Cancer Treatment

Clinical Trials

Below is a list of Cancer Treatment clinical trials from the clinical trials database at Mayo Clinic.

This list includes only trials about which Mayo researchers choose to publish information. Mayo Clinic may be conducting other trials which are not in this database. Mayo's clinical trials include experimental treatments, often unavailable elsewhere, which frequently lead to improved patient care for people worldwide. Patients should ask their doctor at Mayo about clinical trials appropriate for their situation.

A Phase Ib Study of SGN-40 (anti-huCD40 mAb) in Combination with Rituximab (Rituxan) and Gemcitabine (Gemzar) for the Treatment of Patients with Relapsed or Refractory (resistant) Diffuse Large B Cell Lymphoma (DLBCL)
Patients are being asked to take part in this research study because they have relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

The purpose of this study is to test how well an investigational drug called SGN-40 works in combination with gemcitabine and rituximab, two commonly used drugs for certain types of cancer. The study doctors hope to find out what a safe dose is when these three study drugs are combined, what the side effects are, and whether or not they are an effective combination in treating relapsed or refractory DLBCL. More than 100 people with cancer have received SGN-40 in earlier research studies. These previous research studies were used to evaluate the safety of different doses and schedules of SGN-40 when given on its own.
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A Phase II Study of Pemetrexed (Alimta) With Sorafenib (Nexavar) Versus Pemetrexed Alone as Second-line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Patients are being asked to take part in this research study because they have been diagnosed with non-small cell lung cancer (NSCLC).

The purpose of this research study is to:
- Compare the effects, good and/or bad, of using BAY 43-9006 in combination with pemetrexed versus pemetrexed alone, on the patient's non-small cell lung cancer (NSCLC)
- Find out if there are individual differences and/or tumor characteristics that will affect response to treatment

BAY 43-9006 is an U.S. Food and Drug Administration (FDA)-approved drug for the treatment of kidney cancer. Pemetrexed is a standard chemotherapy drug that is used in patients with this type of lung cancer that did not respond to or that progressed after a first course of treatment.
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MC0542 - Phase II Study of 17-N-Allylamino-17- Demethoxygeldanamycin (17-AAG) (Tanespimycin) In Combination With Gemcitabine (Gemzar) In Patients With Metastatic Pancreatic Cancer
Patients are being asked to take part in this research study to find out the effects (good and bad) of the combination of gemcitabine and 17AAG has on a patient and their metastatic pancreatic cancer. Gemcitabine is a chemotherapy drug approved by the U.S. Food and Drug Administration (FDA) for use in metastatic pancreatic cancer. 17AAG is an investigational or experimental anti-cancer agent that has not yet been approved by the FDA for use in metastatic pancreatic cancer.
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MC0785, Antibody Therapy with Alemtuzumab (Campath), Rituximab (Rituxan), and GMCSF (Sargramostim) for Initial Treatment of High Risk Chronic Lymphocytic Leukemia (CLL)
Patients are being asked to take part in this research study because they have been diagnosed with chronic lymphocytic leukemia (CLL). This study is being done to see how their disease responds to treatment.
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N063D/BIG 2-06, ALTTO: Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Study - A randomised, multi-centre, open-label,phase III study of adjuvant lapatinib, trastuzumab, their sequence and their combination in patients with HER2/ErbB2 positive primary breast cancer
Patients are being asked to take part in this research study because they have early stage HER2 positive (HER2+) breast cancer that has been surgically removed. Patients will also have received some chemotherapy to treat the cancer. The most common treatment used in the United States and Canada is doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan) - sometimes referred to as "AC," but it's possible the patient will have received another treatment.
The purpose of this research study is to:
- Find out what effects (good and bad) the study treatment has on the patient and their cancer.
- Compare four different study treatment combinations to see if one is better
- Find out what effects this study has on a patient's quality of life.

Because of recent research by North Central Cancer Treatment Group (NCCTG), the
standard treatment for HER2+ breast cancer now includes trastuzumab (Herceptin).
However, not all patients with HER2+ breast cancer do better with trastuzumab, so
investigators are trying to find out why.

GW572016 (lapatinib, brand name: Tykerb) is a new drug that is taken every day by mouth. Lapatinib is considered "investigational" in this study. "Investigational" means that the U.S. Food and Drug Administration (FDA) has not approved lapatinib as a treatment for early breast cancer.

This study is comparing trastuzumab to lapatinib and each drug alone to two
combinations of trastuzumab and lapatinib. The four treatments being studied here are:
- Group 1 - Standard treatment of trastuzumab alone for one year
- Group 2 - Lapatinib alone for one year
- Group 3 - Trastuzumab for 12 weeks followed by a six week break, and then
lapatinib for 34 weeks
- Group 4 - Trastuzumab and lapatinib together for one year
The true benefit of taking lapatinib either instead of trastuzumab or with trastuzumab is not known.
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Phase 2 Study to Evaluate the Safety and Efficacy of Monoclonal Antibody Lumiliximab in Combination with Fludarabine, Cyclophosphamide (Cytoxan), and Rituximab (Rituxan) Versus Fludarabine, Cyclophosphamide, and Rituximab Alone in Patients with Relapsed Chronic Lymphocytic Leukemia (CLL)
Patients are being asked to take part in this research study because their doctor has tested the patient's blood and/or bone marrow and determined that they have a diagnosis of relapsed Chronic Lymphocytic Leukemia (CLL). The purpose of the study is to compare the clinical benefit of Lumiliximab in combination with Fludarabine, Cyclophosphamide, and Rituximab (FCR) to FCR alone and to compare the safety of Lumiliximab when given in combination with FCR to FCR alone. This will include looking at what side effects occur and how often they occur.
Lumiliximab is an investigational drug made by Biogen Idec Inc. (Biogen Idec) that is
being studied for the treatment of relapsed chronic lymphocytic leukemia (CLL). Regulatory authorities have not yet approved lumiliximab for general use, but they have allowed it for use in clinical trials. Lumiliximab is a monoclonal antibody made of monkey and human proteins. A monoclonal antibody is a substance made in the laboratory that binds to a specific protein. Although doctors don't know exactly how lumiliximab works, it is believed that lumiliximab binds to a protein on CLL cells and causes them to die.
At the time of this summary, a total of 257 patients have received lumiliximab. This includes patients with CLL as well as patients with allergic disorders. In clinical trials in patients with CLL, lumiliximab has been given alone as well as with fludarabine, cyclophosphamide, and rituximab (FCR), a drug combination frequently used to treat people with CLL.
Fludarabine is a type of chemotherapy drug, which has been approved for the treatment of patients with CLL. Cyclophosphamide is another approved chemotherapy drug often given with fludarabine. Rituximab is a monoclonal antibody made of mouse and human proteins. It attaches to a specific protein found on most CLL cells. Rituximab has been approved in the US, Canada, and Europe for the treatment of some cancers. Although rituximab is commonly used for the treatment of CLL, it has not been approved for this disease.
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Phase 3 Study of Treatment for Newly Diagnosed Higher Risk Favorable Histology Wilms Tumor
Patients are being asked to take part in this study because they have a Wilms tumor in which the cancer cells look almost like normal cells in the kidney (this is called favorable histology).
There is, however, some risk that the cancer will return after treatment.

It is common to enroll children and adolescents with cancer in a clinical trial that seeks to
improve cancer treatment over time. Clinical trials include only people who choose to take
part. Patients have a choice between a standard treatment for Wilms tumor and this clinical trial.
The usual treatment for people with these tumors is to have surgery to remove as much tumor as possible, then anti-cancer drug therapy (chemotherapy), and some therapy with high energy X-ray (radiation therapy).

Chemotherapy and radiation have side effects and late effects, so study doctors are trying to find out the amount of treatment to give patients that will treat their cancer and at the same time have less of these effects. Late effects are health problems that happen to patients later in life because of the drugs or radiation used to treat their cancer. Late effects may include health problems such as poor growth, inability to have children, impaired organ function (such as problems with breathing, poor heart function or heart failure) or the development of a second type of cancer.

The overall goal of this study is to find out if:
Patients with Wilms tumor that has spread only to their lungs can be treated without having radiation therapy to their lungs. Patients whose lung tumors go away completely after the first six weeks of standard chemotherapy will not have to have radiation therapy

Patients with Wilms tumor that has spread only to their lungs whose lung tumors do not go away after the first six weeks of standard chemotherapy for Wilms tumor can be treated by using two additional chemotherapy drugs, plus radiation therapy

Patients who have Wilms tumor that has spread to other parts of the body in addition to or instead of in the lungs, can be treated by using two additional chemotherapy drugs along with the standard drugs, and radiation therapy

Some genetic information about the tumor cells can help the researchers put patients in the experimental treatment group.
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Phase I/II Study of PS-341 (Velcade) in Combination with Paclitaxel (Taxol), Carboplatin, and Concurrent Thoracic (Lung) Radiation Therapy for Non-small Cell Lung Cancer (NSCLC)
This study is being done to find the highest dose of the investigational drug PS-341 that can be given in combination with carboplatin, paclitaxel, and radiation therapy without causing bad side effects.
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Phase II Study of Rituximab (Rituxan) Given in Conjunction with Standard Chemotherapy in Primary Central Nervous System (CNS) Lymphoma
The purpose of this study is to decide if the addition of rituximab to a standard chemotherapy regimen improves the likelihood of the tumor responding to treatment, and to determine how well the tumor can be controlled without the use of radiation therapy.
Although rituximab is widely used and effective in the treatment of lymphoma, it is not currently known if it will work for lymphoma occurring in the brain (primary central nervous system lymphoma). When used for other lymphomas, rituximab has improved the results of chemotherapy with very little or no additional side effects.
Both chemotherapy alone and chemotherapy combined with radiation have been effective in primary central nervous system lymphoma. It is not known if the radiation is necessary, but it is known that the risk of severe side effects affecting intellect and personality (dementia) is high after combined radiation and chemotherapy. For this reason, radiation will not be used as part of this protocol. The choice of using radiation later if the disease gets worse or comes back remains, and the patient would then discuss that with their doctor.
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R-04, A Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine (Xeloda) with or without Oxaliplatin with Preoperative Radiation Therapy and Continuous Intravenous (IV) Infusion of 5-Fluorouracil (5FU) with or without Oxaliplatin in the Treatment of Patients with Operable Cancer of the Rectum
This study is being done with patients with rectal cancer to:
- See if taking a drug called capecitabine as a pill, twice a day by mouth during the weeks a patient receives radiation therapy, is as good as the standard treatment with the drug 5-fluorouracil (5-FU) given continuously into a patient's vein during the weeks the patient receives radiation therapy.
- See if adding oxaliplatin to capecitabine and 5-FU can improve how well these drugs work. At this time researchers do not know which chemotherapy drugs, when combined with radiation therapy, are most effective for this type of cancer.
- Look at the four different treatment options by obtaining important information regarding quality of life.
- The U.S. Food and Drug Administration (FDA) currently considers the use of both capecitabine and oxaliplatin to be investigational when given before surgery to remove this type of cancer.
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06-213 A Phase 2 Study of Lapatinib (Tykerb) in Combination with Trastuzumab (Herceptin) in Patients with HER2-Positive, Metastatic Breast Cancer
Patients are being asked to take part in this research study because they have breast cancer that has spread to other parts of their body. This research study is evaluating a drug called lapatinib as a possible treatment for breast cancer. In this study, the drug is combined with trastuzumab (Herceptin), which is a standard treatment for breast cancer. The FDA (the U.S. Food and Drug Administration) has not yet approved this drug combination for use for this type of cancer. Lapatinib is approved for use in this type of cancer when used in combination with capecitabine (Xeloda), a type of chemotherapy. Therefore, the use of the combination of Lapatinib and Herceptin is investigational. The purpose of this research study is to determine the effects that the combination of the study drug (lapatinib) plus Herceptin has on a patient and their cancer. Lapatinib is a compound that may stop cancer cells from growing.

This drug has been used in other research studies of patients with breast cancer and information from those research studies suggests that lapatinib in combination with Herceptin may help to shrink or stabilize breast cancer in this research study. In this research study, the staff are studying the effects of the combination of lapatinib plus Herceptin in patients with breast cancer that has spread outside of the breast. The researchers are also studying whether positron emission tomography (PET/CT) scans can predict which patients will benefit from the study treatment. Finally, the research staff are studying genes and proteins in the patient's tumor tissue that may lead to sensitivity or resistance to Herceptin and to the combination of Herceptin plus lapatinib. The researchers are also studying genes and proteins in the patient's tumor tissue to try to understand the changes that might occur to allow cancers to spread and/or to grow.
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12345 A Study to Evaluate Changes in Phosphate Regulating Factors in Patients with Advanced Renal Cell Carcinoma (RCC) Treated with Sorafenib (Nexavar)
Patients are being asked to take part in this research study because they have a disease called advanced renal cell carcinoma (RCC). Patients will be taking a drug called sorafenib (Nexavar). Sorafenib is an anti-cancer medication that is currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of renal cell carcinoma.
The results of this study may help researchers understand how treating RCC patients with sorafenib may be linked to low phosphorous level in the blood, and how this low phosphorous level may or may not affect bone mineral density (BMD). Bone mineral density is a way of measuring bone strength. By measuring BMD it is possible to predict bone fracture risk in the same manner that measuring blood pressure can help predict the risk of stroke. The research staff also want to learn whether sorafenib treatment has any effect on the ability of the heart to pump blood efficiently.
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A Dose-Finding Study of CpG 7909 in Previously Treated Chronic Lymphocytic Leukemia
The purpose of this research study is to evaluate the use of CpG 7909. CpG 7909 is a short strand of DNA, the genetic material found in cells. CpG 7909 has the potential to stimulate the immune system, and we are studying these effects to learn if CpG 7909 has potentially beneficial effects in people with chronic lymphocytic leukemia. The purpose of this research study is to see if we can measure biological changes in Chronic Lymphocytic Leukemia (CLL) cells and chemicals in your blood after receiving CpG 7909.
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A Molecular Staging Study of Endometrial Cancer (GOG 0210)
This research study is being done to:

• Collect tissue, urine and blood samples from patients who have endometrial cancer.
• Collect information from patients (for example: age, race, level of education, health history, family health history, and treatments for cancer).
• Learn more about, treat and prevent endometrial cancer.
• Create a tissue storage bank for samples sent to the studys sponsor, the Gynecologic Oncology Group (GOG).

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A Phase 1-2, Multicenter, Open-Label Study of the X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 Given in Combination with Gemcitabine (Gemzar) in Patients with Advanced Pancreatic Cancer
Patients are being asked to take part in this research study because they have advanced pancreatic cancer and are a candidate for chemotherapy with a drug called gemcitabine, which is currently a standard treatment for pancreatic cancer.

This study is being done to find out what dose of a new drug, named AEG35156, given in combination with the standard chemotherapy drug, gemcitabine, will work the best and without causing unacceptable side effects.

The study drug AEG35156 is not approved by the U.S. Food and Drug Administration (FDA) for use outside of this clinical study. Gemcitabine is a chemotherapy drug which has been approved by FDA for the treatment of advance pancreatic cancer.

The primary purpose of this study is to:
- Find out how much of the study drug (AEG35156), when taken with standard doses of gemcitabine, can be given without causing bad side effects
- See if the study drug can improve the effectiveness of the gemcitabine
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A Phase 1b Dose Escalation/Phase 2 Randomized, Noncomparative, Multiple Center, Open Label Study of CP-751,871 in Combination with Paclitaxel and Carboplatin and of Paclitaxel and Carboplatin Alone as First Line Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC)
This study is being done to learn:
- The highest safe dose of the cancer drug called CP-751,871 that can be given every three weeks with paclitaxel and carboplatin to patients with cancer without causing bad side effects;
- About the side effects (good or bad) of CP-751,871, paclitaxel and carboplatin when given together;
- How the body handles or processes CP-751,871 when given with paclitaxel and carboplatin;
- If the patient's body generates antibodies (substances produced by the immune system to help fight infectious or foreign materials) against CP-751,871; and
- If CP-751,871 helps paclitaxel and carboplatin to fight the patient's cancer.

CP-751,871 is an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA) for standard clinical use. This drug will be available to patients only during this study. Paclitaxel has been approved by the FDA for the treatment of lung cancer, but has not been approved in the combination used in this study, and its use is considered investigational. Carboplatin has been approved by the FDA for the treatment of ovarian cancer, but has not been approved in the combination used in this study, and its use is also considered investigational.
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A Phase 2 Trial of Irinotecan (Camptostar, CPT-11), Oxaliplatin, and Capecitabine (Xeloda) as First-Line Treatment for Advanced Small Intestine Cancer
Adenocarcinoma of the small bowel is a rare form of cancer. At this time, there is no standard treatment known to make it better. A small study was done and that study showed that combining the drugs irinotecan, oxaliplatin, 5-fluorouracil, and leucovorin made tumors get smaller in some patients whose cancer had spread to other parts of their body. In another study, though, this treatment caused some bad side effects. This new study has included a change of the 5-fluorouracil and leucovorin to a similar oral medication called capecitabine. It also tests one of the patient's genes to determine the dose of chemotherapy to be used. The investigators made these changes to try to make the drug combination safer for use in patients.
The main purpose of this research study is to see if small bowel cancer tumors get smaller when treated with irinotecan, oxaliplatin, and capecitabine (a newer, oral form of 5-fluorouracil) based on the dose of the medications determined by a gene called UGT1A1. The researchers will also look at what the side effects of the chemotherapy drugs are.


The gene UGT1A1 makes a protein that affects how the chemotherapy drugs, especially the irinotecan, affect a patient's body. People with certain type of the UGT1A1 are more likely to get the side effects from one of the drugs, irinotecan. In this research study, the researchers will test a sample of the patient's blood to find out what type of UGT1A1 they have and that will help the researchers decide what dose of the chemotherapy drugs to give the patient. People with different UGT1A1 types will get different doses of this chemotherapy.

Part of the purpose of this research study is to try two different ways to help patients have fewer side effects when irinotecan, oxaliplatin, and capecitabine are used together.
- The researchers will look to see if giving different doses of this chemotherapy to patients with different UGT1A1 types will cause fewer side effects. The dose may affect how bad the side effects are.
- The researchers will use the newer version of 5-fluorouracil called capecitabine. Capecitabine is a tablet that will be taken by mouth instead being injected into a vein.
Also, the research staff want to find out if this chemotherapy works better in some types of small bowel tumors than others. Tumor types may be different, for example, because of where in the small intestine the tumor started or because of errors in the DNA. The researchers will look to see if patients with small bowel cancer also have another disease called celiac disease (also called sprue) and how that affects treatment. The research staff will look at patients blood samples and tissue samples to find out what type of small bowel tumor the patient has and whether or not they also have celiac disease.
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A Phase 2, Study of Carfilzomib in Patients with Relapsed Multiple Myeloma
Patients are being asked to take part in this research study because they have a cancer of the blood called multiple myeloma.
The purpose of this study is to see how safe and effective an investigational new drug [a drug that has not received approval by the U.S. Food and Drug Administration (FDA)] called carfilzomib is in patients with multiple myeloma who have received prior treatment for their disease. The research staff want to find out what effects, good and/or bad, it has on the patient and their cancer.
Carfilzomib is a type of drug called a proteasome inhibitor. A proteasome is a protein found within cells that has the important role of identifying and marking damaged proteins that are needed to be destroyed by the cell for survival. The inhibition of the proteasome allows for damaged protein to build up within cells. This build up of damaged protein causes the cell to die. In the laboratory, the way carfilzomib works is similar to another drug that has been approved by the FDA to treat Multiple Myeloma.
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A Phase 3 Clinical Study to Investigate the Prevention of Relapse in Lymphoma [Diffuse Large B-Cell Lymphoma (DLBCL)] Using Daily Enzastaurin (LY317615.HCl)
This study will compare patients who are using the investigational drug enzastaurin every day, to patients who are following the current standard of care. This will help us:

- Find out what effects (good and bad) the enzastaurin (a drug) has on the patient and their cancer
- Determine if there are indicators (markers) in a patient's blood or tissue that might tell us if an individual would respond better to this drug than others
- Find out how enzastaurin is used by the body, how long it stays in the body, and how the body gets rid of it
- Find out what effect this drug has on a patient's over all quality of life. We will do this by having patients complete questionnaires at some of their study visits.
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A Phase 3 Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg) Combined with Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults
Acute myeloid leukemia (AML) is a cancer of the bone marrow, the spongy tissue inside the large bones of the body where blood cells are made. In AML, the bone marrow makes large numbers of immature white blood cells called blasts. These blast cells crowd out the normal cells of the bone marrow. They may flood the bloodstream and invade vital organs such as the brain, testes, ovaries, or skin. These cancerous AML cells can sometimes form a solid tumor called a chloroma.

The standard treatment for this disease is to use a combination of cancer-fighting drugs called chemotherapy. Chemotherapy destroys the leukemia cells in the blood and bone marrow. In the first phase, called Induction 1, the medical team tries to remove all visible signs of leukemia and allow normal blood cells to be restored. This is called remission. The next phase of treatment is called Induction 2. Induction 2 is another round of chemotherapy to kill the few remaining leukemia cells that may have survived Induction 1. In the next phase of treatment, called Intensification 1, more chemotherapy is used to kill any remaining blast cells. Then the medical team does a Stem Cell Transplantation (SCT) or gives additional high doses of chemotherapy to try to keep the leukemia from coming back.

Nearly 500 children are diagnosed with AML every year, and half are cured with standard therapy. In other words, half of the children diagnosed with AML and treated as described above remain with no signs of cancer (remission) for five years. The overall goal of this study is to see if the research staff can increase this cure rate without causing more serious side effects of therapy. Side effects are unintended and unwanted results of treatment.

Researchers want to know if they can improve the cure rate for AML by adding a new chemotherapy drug, called gemtuzumab, to the standard chemotherapy treatments.
Gemtuzumab has been studied in adults with AML in combination with standard chemotherapy drugs. It has also been studied in small groups of pediatric patients. These studies have determined what dose of gemtuzumab can be given safely with other chemotherapy drugs.

Another goal of this study is to determine which children with AML need a stem cell transplant and which children do not. During intensification treatment, the study doctors will assign patients to either receive more chemotherapy, or a stem cell transplant. This is decided based on two factors: 1) the patient's risk of AML coming back, and 2) if they have a matched stem cell donor available.

The research staff will also be studying how well children with Down syndrome do on the standard therapy. Down syndrome patients may respond differently to chemotherapy drugs than patients without Down syndrome. This study will give study doctors information about how Down syndrome patients respond to standard therapy.

A secondary goal of the study is to understand the biology of AML better. These tests are optional and will be done only if the patient agrees. Study doctors want to test blood or bone marrow for certain genetic changes in leukemia cells. This would help them to learn more about AML and how to treat patients better. They also want to look for very small amounts of leukemia. This is called minimal residual disease (MRD). Researchers want to find out if measuring MRD can be used in the future to decide how great the risk of relapse is for a person.

In summary, the goals of this study are:
1. To see if adding a new drug called gemtuzumab to the current standard AML treatment will improve the cure rate without causing more serious side effects
2. To compare the outcomes of children who have higher risk disease and receive a stem cell transplant to children who do not have higher risk disease
3. To evaluate how well children with Down syndrome (who are over four years old) do when they receive the standard chemotherapy without gemtuzumab
4. To understand the biology of AML better with the optional biology tests

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A Phase 3 Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy (18.00 Gy) and Chemotherapy in Children with Newly Diagnosed Standard Risk Medulloblastoma
This study is being done to:
- Find out if the overall dose of radiation to the brain and spine can be lowered without lowering rates of survival in children with medulloblastoma
- See if the volume of radiation given during the boost (extra radiation sent to the tumor area) can be lowered without lowering survival rates in children with medulloblastoma

Secondary goals of this study are to:
- Look at what characteristics are shared among children who are treated with a smaller amount of boost dose of radiation and have their cancer come back
- Look for the effects of lower radiation on children's hearing, ability to learn, and hormone function
- See if children given a smaller amount of boost dose radiation have fewer side effects to their hearing and hormone function compared to children that get the standard amount boost dose
- Develop a marker from the tumor's DNA that can tell how a child with medulloblastoma cancer may progress
.
Standard therapy for medulloblastoma includes surgery followed by radiation therapy (use of high-energy x-rays to kill cancer cells) to the brain and spinal cord with or without chemotherapy (treatment with anti-cancer drugs).

Recent studies using a combination of chemotherapy and radiation therapy to treat children with standard risk medulloblastoma have been 70 and 80 percent effective in curing this disease. However, many children have long-term side effects from radiation therapy to the brain and spine, including hearing loss, changes in hormone function (which can impact growth and sexual development), and learning problems (especially in younger children).

This study will look at what will happen if a smaller amount of radiation therapy is given to the brain and spinal cord of children with medulloblastoma. Some patients on this study will be given a standard dose of radiation and others will get a lowered dose.

This study will also look at what will happen if the amount of radiation that is given during the "boost dose" of radiation is lowered. Some patients on this study will be given a standard-amount boost, which means that the radiation is aimed at the entire area at the back of the brain. Other patients will be given a smaller amount boost which means that they will be given radiation aimed more directly to the tumor bed. All patients on this study will be treated with chemotherapy during and after radiation therapy.
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A Phase 3 Study of Reduced Therapy in the Treatment of Children with Low and Intermediate Risk Extracranial Germ Cell Tumors
This study is being done to:
- Avoid chemotherapy in low risk testicular/ovarian germ cell tumors by using surgery and observation, and using chemotherapy only if the tumor comes back.
- Lower the total amount of chemotherapy cycles given (three times instead of four)
for those patients getting chemotherapy and find out the effects, good and/or bad.
- Lower the number of days over which the chemotherapy is given from five to three days.
A secondary goal of the study is to understand the biology of germ cell tumors better.
Researchers would like to know more about the genetic factors that affects the development of germ cell tumors.
Patients are being asked to take part in this study because they have been told that they have a germ cell tumor. A germ cell tumor is a type of cancer that happens in the ovaries (for females) or the testes (for males). This tumor may also be found in other areas of the
body such as the brain, chest or abdomen.
A germ cell tumor is considered low risk when it is present only in the testes or ovaries and is completely taken out by surgery.
A germ cell tumor is considered intermediate risk when:
- It is present only in the testes or ovary, but is not completely taken out by surgery.
- It is present in the testes or ovary and has spread to the lymph nodes or other organs.
- It is present only at one site outside the ovaries or testes, but may or may not be completely taken out by surgery.
The term, risk, refers to the chance of the cancer coming back after treatment.

The standard treatment for patients who have low risk testicular tumors is surgery to take out the tumor and observation; the standard treatment for patients with low risk ovarian tumors is surgery plus chemotherapy (cancer-fighting drugs) given for four cycles (with five days for each cycle of treatment).
The standard treatment for patients with intermediate risk germ cell tumors is surgery plus chemotherapy given for four cycles (with five days for each cycle of treatment).
Germ cell tumors are rare, and account for only 3 percent of all childhood cancers. However, the survival rate for patients with these types of tumors is very high at 95 percent for low risk tumors and 93 percent for intermediate risk tumors.
The standard treatment for germ cell tumors is very effective. Study doctors would like to know if it is possible to lower the side effects from chemotherapy treatment. Side effects are unintended or unwanted results. When chemotherapy is lowered, there have been fewer side effects from chemotherapy. This study will test if lowering the amount of chemotherapy given to intermediate risk tumor patients and not giving chemotherapy to low risk patients will result in the same high survival rate.
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A Phase I and Pharmacological Clinical Trial of 17-Allylamino-17-demethoxygeldanamycin (17-AAG) and Cytarabine (Ara-C) in Refractory (Resistent) Leukemia and Myelodysplastic Syndrome (MDS)
- Find the highest dose of the cancer drugs called 17-AAG (17-Allylamino-17-
demethoxygeldanamycin) and cytarabine that can be given in a 60-day schedule to patients with advanced cancer without causing bad side effects
- Learn about the side effects of 17-AAG and cytarabine when given together
- Learn how the body handles or processes the drugs and learn the other effects the drugs have on the body using blood and bone marrow samples

17-AAG is an investigational drug that has not been approved by the U.S. Food and Drug
Administration (FDA), or any other regulatory agency, for commercial use but is approved by the FDA for use in this research study. Cytarabine has been approved by the FDA for the treatment of acute myelogenous leukemia. This study will provide information that will allow the investigators to further study if the combination is more effective than each drug given alone.
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A Phase I Dose Escalation Study of the PKC Inhibitor, Aurothiomalate (ATM) in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
Background:
- PKCé is a protein that may help one type of lung cancer to grow.
- Gold sodium thiomalate (ATM) may block the effects of PKCé.
- This study is the first step in trying to find out if ATM can be used safely in the
treatment of the type of lung cancer that depends on PKCé for growth.
This study is being done:
- To find the highest dose of the PKCé inhibitor, ATM, that can be given to patients
with advanced non-small cell lung cancer (NSCLC) without causing bad side
effects;
- to learn if ATM can stop or slow the growth of a patient's NSCLC tumor;
- to learn about the side effects of ATM when given to patients with NSCLC; and
- to learn how the body handles or processes ATM and how ATM affects the body
using blood and tissue samples and in some cases, positron emission tomography
(PET) imaging.
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A Phase I Study of Aminoflavone (AFP464) for the Treatment of Cancer
This study is being done to:
- test the safety of a drug called Aminoflavone (AFP464) and see what effects (good and bad) it has on patients with solid tumors;
- find the highest dose of AFP464 that can be given without causing bad side
effects; and to
- learn how the body handles or processes the drug.
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A Phase I Study of Weekly Oral ZEN-012, a Small Molecule Anti-Cancer Agent, in Patients With Advanced Cancer and Lymphoma
Patients are being asked to take part in this research study because they have cancer that has continued to grow despite the treatments they may have already received. Either the standard drugs used to treat their disease are no longer working or there are no known treatments that work because the patient's tumor cells may be resistant to these treatments. This clinical trial is about testing ZEN-012 which is a newly discovered chemical compound. It belongs to a group of drugs which may stop tumor cell growth.
This study is being done to:
- test the safety of ZEN-012 and see what effect (good and bad) it has on the patient and their cancer
- find the highest dose of ZEN-012 that can be given without causing bad side effects.

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A Phase I Study of Weekly Oral ZEN-012, a Small Molecule Anti-Cancer Agent, in Patients With Advanced Cancer and Lymphoma
Patients are being asked to take part in this research study because they have cancer that has continued to grow despite the treatments they may have already received. Either the standard drugs used to treat their disease are no longer working or there are no known treatments that work because the patient's tumor cells may be resistant to these treatments. This clinical trial is about testing ZEN-012 which is a newly discovered chemical compound. It belongs to a group of drugs which may stop tumor cell growth.

This study is being done to:
- Test the safety of ZEN-012 and see what effect (good and bad) it has on the patient and their cancer
- Find the highest dose of ZEN-012 that can be given without causing bad side
effects
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A Phase I Trial of 17-Allylaminogeldanamycin (17-AAG) and PS341 (Velcade) in Advanced Malignancies (Cancer)
This study is being done to:
- Find the highest dose of the cancer drugs called 17AAG and PS341 that can be given to patients with advanced cancers without causing unacceptable side effects
- Learn about the side effects of 17AAG and PS341 when given together
-
The combination of 17AAG and PS341 is investigational. This means that the combination has not been approved by the U.S. Food and Drug Administration (FDA). This is a "phase I" study. Phase I studies are offered only to patients for whom standard treatments have not been helpful.
To find the highest safe doses of 17AAG and PS341 that can be given together, the first group of three to six patients will receive lower doses of the drugs. If these patients do not have severe side effects, the next group of three to six patients will get higher doses of one of the two drugs. The doses will be increased until at least some patients have severe side effects.

The dose that a patient gets may increase during this study, but if they have bad side effects their dose may also be lowered at future visits. All patients will be watched carefully for any serious side effects. These side effects cannot be completely known ahead of time. Phase I studies may involve significant risks for this reason.
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A Phase I/II Study of the Raf Kinase/VEGFR Inhibitor Sorafenib (Bay 43-9006) in Combination with the mTOR Inhibitor RAD001 (Everolimus, Certican) in Patients with Relapsed Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Multiple Myeloma
Sorafenib and RAD001 are two drugs that block some of the main switch pathways in tumor cells from working properly. When combined, it is hoped that they might prevent the cells from growing or cause them to die. Preliminary experiments with RAD001 in lymphoma patients have shown definite anti-tumor activity.
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A Phase II Study of Conformal Radiotherapy in Patients with Low-Grade Gliomas
Older children with low grade gliomas that have come back after surgery or are causing problems are often treated with radiation therapy. Younger children are usually treated first with chemotherapy but, if the tumor comes back after chemotherapy, they then often also get radiation therapy.

Radiation therapy can cause severe side effects (a problem that happens when the treatment affects the healthy parts of a patient's body). New types of radiation therapy can treat a
smaller area of the body and doctors think that patients who get these kinds of radiation might have fewer side effects. The purpose of this study is to test the safety and effectiveness of this "smaller field radiation" in patients with low grade gliomas. This study will also try to find out if the results of a special test performed on the tumor tissue are related to the way the tumor responds to radiation.
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A Phase II Trial of CC-4047 (Actimid) Plus Dexamethasone (Decadron) in Patients with Relapsed or Refractory (Resistant) Multiple Myeloma
Patients are being asked to take part in this research study because they have multiple myeloma that has recurred after initial treatment. CC-4047 is a new drug that is related to thalidomide and lenalidomide. The research staff is studying the effects, both good and bad, of CC-4047 in combination with dexamethasone in patients with multiple myeloma that has recurred after initial treatment.
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A Phase II Trial of Chemotherapy and Radiation Therapy Before Surgery (local excision) in Patients with Rectal Cancer
This study is being done to test whether giving patients a combination of chemotherapy and radiation before the cancer is surgically removed with a procedure called local excision can effectively treat the cancer. We also want to find out what effect that treatment has on the patient's quality of life.

We hope that by giving patients the combination of chemotherapy and radiation before surgery, the tumor will shrink. This will allow the doctor to remove the cancer with a local excision, a surgical procedure designed to leave as much of the rectum and lower intestine intact as possible while still removing all of the cancer. This operation has a better chance of allowing patients to continue to have normal bowel function than the standard therapy for this kind of cancer.
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A Phase II Trial of Gemcitabine (Gemzar) in combination with 17-Allylaminogeldanamycin (17AAG) (Tanespimycin) in Advanced Epithelial Ovarian and Primary Peritoneal Cancer
Gemcitabine is a U.S. Food and Drug Administration (FDA)-approved anti-cancer drug. 17AAG is an investigational drug. This study is being done to determine the effects (both good and bad), of gemcitabine in combination with 17AAG, when used in the treatment of patients with ovarian and primary peritoneal cancer. In particular, the effects of the gemcitabine/17AAG combination on cancer growth and extent will be evaluated using blood tests (such as CA125) and other testing (such as CT scans and chest x-rays) as suited for patients receiving both gemcitabine and 17AAG. Additionally, side effects of gemcitabine and 17AAG will be closely watched, with dosage changes made as needed to protect the health of treated patients. 17AAG can cause the damage of some kinds of proteins in cancer cells that keep the cancer from dying and promote the growth of the cancer. By destroying these proteins, 17AAG may shrink the cancer or slow the growth of the cancer. In experiments done by Dr. Haluska and his collegues, the effects of 17AAG on cancer cell death was greatly increased when gemcitabine was given prior. In patients that have previously received gemcitabine, we will learn whether 17AAG can reverse tumor resistance to gemcitabine and shrink tumors in patients with ovarian and primary peritoneal cancers. In patients who have had no prior exposure to gemcitabine, we will learn whether the combination of gemcitabine and 17AAG has the ability to shrink tumors in patients with ovarian and primary peritoneal cancers.
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A Phase II/III Randomized Study of CDX-110 Vaccine with Radiation and Temozolomide (Temodar) in Patients with Newly Diagnosed Glioblastoma Multiforme
Patients are being asked to take part in this research study because they have been diagnosed with glioblastoma multiforme (GBM) and have had surgery to have it removed. Their doctor has also determined that temozolomide, a commonly used chemotherapy for this disease, is an appropriate therapy for the patient. This study will find out whether adding the CDX-110+GM-CSF vaccine to temozolomide is better or worse than temozolomide by itself at preventing brain tumors from growing, and helping patients with brain tumors live longer.

The CDX-110 + GM-CSF vaccine is an experimental (investigational) vaccine that is being tested to treat glioblastoma by activating the immune system to fight the cancer.
An investigational vaccine is one that is not approved by the U.S. Food and Drug Administration (FDA). The purpose of CDX-110 is to "train" the immune system to recognize a protein called EGFRvIII. About half of the glioblastoma tumors contain EGFRvIII, and EGFRvIII has only been found in cancer cells. It is hoped that when CDX-110 is given to a patient with a glioblastoma tumor containing EGFRvIII, the immune system will "recognize" and kill the glioblastoma cells.

GM-CSF is a man-made version of a substance naturally produced by a patient's body that "activates" the immune system. GM-CSF has been approved by the FDA as a treatment to help bone marrow recovery after bone marrow transplants, and to help restore white blood cells after chemotherapy in certain cancer patients. GM-CSF has also been used in many clinical studies, including studies that investigate GM-CSF in combination with different cancer vaccines as an "immune activator". Thus, it is hoped that using GM-CSF with CDX-110 will increase the immune response against tumor cells.
Patients will receive GM-CSF at a dose of 150 micrograms. This dose is significantly lower than the FDA approved dose for bone marrow stimulation (the study dose is about one-third of the FDA-approved dose).

Temozolomide is a chemotherapy drug (capsule that is taken by mouth) that has been approved by the FDA for the treatment of brain cancer. Temozolomide, along with radiation therapy and surgery, is currently the most common treatment, and is generally considered the best available treatment, for this type of brain tumor.
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A Phase III Randomized Study of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery for Patients with One to Three Brain Metastases
This study is being done to:
- Compare overall survival and to compare the effects (good and bad) of stereotactic radiosurgery (SRS) to SRS plus whole brain radiation therapy (WBRT) on a patient and his/her brain metastases.
- Find out if adding WBRT to SRS will offer any additional benefit to receiving SRS alone in treating these possible microscopic tumor deposits in the brain. It is not known whether more treatment will be better or worse. There may be microscopic tumor deposits that are not yet visible on imaging (the MRI scan) that may appear in the future.

This study is a clinical trial conducted by the North Central Cancer Treatment Group (NCCTG). Clinical trials are research studies designed to find better ways to treat diseases like cancer.
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A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab (Avastin) for Patients With Completely Resected (removed) Stage IB -IIIA Non-Small Cell Lung Cancer (NSCLC)
Patients are being asked to take part in this research study because they have non-small cell lung cancer, which has been removed by a surgeon. This research is being done because even with the most aggressive after-surgery treatment with chemotherapy, many people still have the lung cancer recur (come back).
The purpose of this study is to determine if adding the new drug bevacizumab to chemotherapy improves the chance for cure for patients who have had surgery for the removal of the lung cancer. The research staff will compare the effects (good and bad) of adding bevacizumab to chemotherapy with standard chemotherapy alone on the patient and their lung cancer to see which is better at preventing the cancer from coming back.
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A Structured Multidisciplinary Intervention to Improve Quality of Life of Patients Receiving Active Oncological Treatment (MC0491)
This research study is being done to learn if carefully planned visits with members of a health care team can improve the quality of life (QOL) and mood issues of the patient and their caregiver compared to standard medical care.
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A Study to Evaluate Changes in Phosphate Regulating Factors in Patients with Advanced Renal Cell Carcinoma (RCC) Treated with Sorafenib (Nexavar)
Patients are being asked to take part in this research study because they have a disease called advanced renal cell carcinoma (RCC). Patients will be taking a drug called sorafenib (Nexavar). Sorafenib is an anti-cancer medication that is currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of renal cell carcinoma. The results of this study may help researchers understand how treating RCC patients with sorafenib may be linked to low phosphorous level in the blood, and how this low phosphorous level may or may not affect bone mineral density (BMD). Bone mineral density is a way of measuring bone strength. By measuring BMD it is possible to predict bone fracture risk in the same manner that measuring blood pressure can help predict the risk of stroke. The research staff also want to learn whether sorafenib treatment has any effect on the ability of the heart to pump blood efficiently.
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AALL06N1, "A Study of Neurocognitive Function in Children Treated for Acute Lymphocytic Leukemia (ALL)"
Patients are being asked to take part in this research study because they have been diagnosed with acute lymphocytic leukemia (ALL) and have agreed to be treated on a COG treatment study. In this study, the researchers want to learn more about children who are treated on the COG studies AALL0232 and AALL0434. In both these treatment studies, patients (people on the study) are randomized (randomized means assigned randomly like the flip of a coin, but it is done by a computer so no one will know what treatment the patient will receive) between two different treatment arms that compare different ways to give the chemotherapy, methotrexate. Methotrexate is given in a two month long phase of treatment called Interim Maintenance.

In this study, the research staff want to closely evaluate side effects that might be due to methotrexate. Specifically, the researchers want to learn more about possible side effects that affect the nervous system. A recent, large study of adult survivors of childhood ALL found no differences between survivors who never received radiation treatments and the general population with respect to the likelihood of being married, having a job, and having health insurance.

However, there are children who have neurologic side effects during therapy, or who have learning disabilities after therapy has ended. This study is looking at whether the use of methotrexate is likely to cause those side effects that affect the nervous system. This study will also look at whether or not the possible side effects are different with the different ways methotrexate is given.


Why Is This Study Being Done?
The study is being done to determine the effects, if any, of methotrexate, on learning skills and memory. Information gathered from previous studies is incomplete. There is currently no way of predicting who is likely to develop nervous system side effects related to the use of methotrexate, regardless of the way that methotrexate is given. Side effects are unintended or unwanted results of treatment. In addition, there is no way of predicting whether the nervous system side effects will be minor or major.

This study will also determine: 1) Whether rare, sudden side effects of leukemia therapy, such as seizures, are associated with learning difficulties; 2) Whether certain genetic traits (qualities of a person?s DNA that make the person unique) are associated with the possibility of methotrexate side effects; 3) Whether changes in the amounts of a substance that is found in the patient?s body are associated with side effects of methotrexate, and; 4) Whether or not a new imaging study, similar to an MRI, will predict who is at risk for side effects related to methotrexate.

The overall goal of this study is to evaluate the potential toxicity associated with methotrexate in more detail.
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AAML0431, The Treatment of Down Syndrome Children with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Under the Age of 4 Years
Parents/ Guardians are being asked to allow their child take part in this study because their child has Down syndrome (DS) and has recently been diagnosed with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS).

AML is a cancer of the bone marrow, the spongy tissue inside large bones where blood cells are made. In AML, the bone marrow makes large numbers of immature white blood
cells called blasts. These blast cells crowd out the normal cells of the bone marrow. They may flood the bloodstream and invade vital organs such as the brain, testes, ovaries, or skin. These cancerous AML cells can sometimes form a solid tumor called a chloroma. Many patients have MDS before they get AML. MDS is a disease in which the body
makes fewer blood cells than usual. Bone marrow in MDS patients does not produce enough healthy blood cells. MDS can develop into leukemia.


What Is The Current Standard Of Treatment For This Disease?
The standard treatment for AML and MDS is to use a combination of cancer-fighting drugs called chemotherapy. Chemotherapy destroys the leukemia cells in the blood and bone marrow. The standard treatment regimen consists of two phases of therapy, called Induction and Intensification. In the Induction phase we try to remove all visible signs of leukemia and allow normal blood cells to be restored. This is called remission. Induction treatment is usually repeated for three cycles of therapy (each cycle 28 days). The next phase of treatment is called Intensification. Intensification chemotherapy is used to kill the few remaining leukemia cells that may have survived Induction. Intensification is usually three cycles of therapy, and includes high dose cytarabine (one of the chemotherapy drugs) in the last cycle. Patients with AML or MDS may also be treated with up to seven doses of cytarabine that is injected into the spinal fluid.

Why Is This Study Being Done?
Research has shown that children with DS are more likely to develop leukemia than children who do not have DS. However, they are also known to respond better to chemotherapy than children with AML who do not have DS.

The overall goal of this study is to see if we can increase the cure rate and decrease the side effects of therapy. Side effects are unintended and unwanted results of treatment. In this study, we will test the effects good and/or bad of changing the order of one of the chemotherapy treatments, high dose cytarabine (Ara-C). Subjects in this study will receive high dose cytarabine earlier in the treatment schedule than in past studies. Since DS patients do well on chemotherapy, study doctors want to see if it is possible to lower the side effects of chemotherapy without lowering the effectiveness of the treatment. Study doctors would like to know the effects good and/or bad of reducing the following chemotherapy treatments:

1) The number of treatments given in the spinal fluid (called ?intrathecal?)
2) The number of doses of daunorubicin, one of the chemotherapy drugs

A secondary goal of the study is to learn more about the biology of AML and MDS in DS patients. These tests are optional and will be done only if the parent/ guardian agree. Briefly, the biology studies will:
? Test for genetic changes in the leukemia cells, and genetic factors which might affect a patient?s likelihood of getting leukemia and outcome with treatment
? Look for very small amounts of cancer cells in the blood and bone marrow, called minimal residual disease (MRD). Researchers want to find out if measuring MRD can be used in the future to decide how great the risk of the cancer coming back is for a person and predict how a patient will do with treatment
? See what happens to high dose cytarabine (one of the chemotherapy drugs) in the body and how much of the drug remains active over an 8-hour period. These are called pharmacokinetic (PK) tests.
? Collect blood and bone marrow specimens and store them in a cell bank for future research into Down syndrome

In summary, the goals of this study are to:
1. See if changing the order of high dose cytarabine in the treatment plan has an affect on the cure rate for DS patients
2. See if lowering the number of treatments into the spinal fluid and the number of doses of daunorubicin will be as effective as standard treatment with fewer side effects
3. Understand the biology of AML and MDS better with the optional biology tests
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ACCL05C1, A Group-Wide, Prospective Study of Ototoxicity (hearing loss) Assessment in Children Receiving Cisplatin Chemotherapy
Patients are being asked to take part in this study because they are scheduled to receive treatment with a chemotherapy (cancer-killing) drug, called cisplatin. Cisplatin is a drug that may cause a side effect called ototoxicity. Ototoxicity is damage to the patient's hearing system that causes hearing loss.


Why Is This Study Being Done?
When people are being treated for cancer they receive chemotherapy drugs that can cause hearing loss. It is standard care to have hearing tests on a regular basis to monitor for hearing loss. The standard type of hearing tests is called conventional audiometry. In this study, researchers want to learn more about evaluating for ototoxicity by looking at conventional audiometry in different ways and by using two new types of hearing tests. These two new tests are called ultrahigh frequency (UHF) audiometry and otoacoustic emission and are more sensitive to measuring hearing loss than conventional tests.


The goals of this study are to:
- Determine the best way to recognize ototoxicity
- Determine if it is possible to use two hearing tests, ultrahigh frequency (UHF) audiometry and evoked otoacoustic emission (OAE), as extra tests to measure ototoxicity
- Have the researchers review the results of all the hearing tests done on patients on this study. This process is called central review. It allows researchers to evaluate the quality of the tests done at all the hospitals taking part in this study.
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ACF4375g: An Open-Label, Phase 1b, Dose-Escalation Study of the Safety and Pharmacology of the Anti-CD40 Monoclonal Antibody SGN-40 Administered in Combination with Bortezomib (Velcade, PS-341) in Patients with Relapsed or Refractory (resistant) Multiple Myeloma
Patients are being asked to take part in this research study because they have a type of cancer called multiple myeloma that has reoccurred after initially responding to treatment or they have failed to respond to a previous treatment. The purpose of this study is to test the safety of SGN-40 at different dose levels when combined with a drug called bortezomib (Velcade). The research staff want to find out what effects, good and/or bad, it has on patients and their multiple myeloma. It will also determine the highest tolerated dose of SGN-40 that may be used in other studies.




The use of SGN-40 in this research study is experimental which means that it is not approved by the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma. Bortezomib is approved by the FDA for the treatment of patients with multiple myeloma who have received at least one prior therapy.
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ACNS0334, A Phase III Study for the Treatment of Newly Diagnosed Supratentorial PNET (primitive neuroectodermal tumor) and High Risk Medulloblastoma in Children < 36 months Old with Intensive Induction Chemotherapy with Methotrexate Followed by Consolidation with Stem Cell Rescue vs. the Same Therapy Without Methotrexate
Study Rationale:
Parents/ Guardians are being asked to allow their child to take part in this study because their child is less than three years old and has a tumor called a high risk medulloblastoma or primitive neuroectodermal tumor (PNET). Left untreated, these tumors are always fatal.


It is common to enroll children and adolescents with cancer in a clinical trial that seeks to improve cancer treatment over time. Clinical trials include only people who choose to take part.


What is the current standard of treatment for this disease?
Treatment for high risk medulloblastoma or primitive neuroectodermal tumor (PNET) in children less than 36 months old usually involves surgery to remove as much of the tumor as possible followed by chemotherapy (anti-cancer drug therapy) and sometimes radiation.

There is no standard treatment for infants and young children with very high-risk medulloblastoma/PNET. Several research studies have treated children less than three years with medulloblastoma/PNET with intense chemotherapy and stem cell rescue. After surgery, patients were given intense chemotherapy (induction) after which the patients own blood stem cells were collected (harvested) and then more intense chemotherapy was given (consolidation). After the intense chemotherapy, the patient?s own blood stem cells were given back to the patient to help recovery (rescue). Blood stem cells are the cells from which new blood cells develop such as red blood cells, white blood cells, and platelets. Blood stem cells can be found in the peripheral blood (bloodstream) or the soft tissue of the bone, called the bone marrow. This approach has been used in an attempt to improve patient survival and to delay, reduce and possibly eliminate radiation therapy.

In some children whose medulloblastoma/PNET came back or got worse, this intense treatment with stem cell rescue improved survival. The treatment has also been used with newly diagnosed patients with high risk medulloblastoma and PNET. Children with minimal tumor left after surgery and/or after chemotherapy appeared to do better. In a clinical trial called ?Head Start 2?, a chemotherapy drug, methotrexate was added to a four drug combination (induction) used in several earlier trials. This was then followed by the intense chemotherapy with stem cell rescue (consolidation). In children with tumors that had metastasized (spread), high rates of complete disappearance of tumor were noted.

Similarly, another clinical study evaluated three cycles of the same four-drug combination (Induction), followed by three cycles with stem cell rescue (consolidation). Side effects for each of the three consolidation cycles with stem cell rescue? often appeared less than the side effects seen with the first three cycles of chemotherapy.

Why is this study being done?
The purpose of this study is to compare two experimental treatment regimens to see if one is better for patients with high risk medulloblastoma or primitive neuroectodermal tumor (PNET). Each regimen consists of induction, consolidation, and blood stem cell rescue.

The difference in the regimens is that in one regimen an additional drug, methotrexate, will be added to the induction therapy. The researchers would like to know if adding methotrexate will prove more effective than not adding methotrexate during induction therapy. The researchers do not know if adding methotrexate will prove more effective and it may cause additional side effects.

Researchers are also going to compare tests and surveys to see how the treatments on this study are affecting the quality of life and development of subjects.

Researchers are also going to do research tests on some of the tumor tissue taken out during surgery. These tests are being done to better understand things about the tumor cells such as the kinds of proteins in them and if they have any genetic differences. The research staff will also collect some blood for these research tests. About one teaspoon of blood will be taken before the child starts treatment. An attempt will be made to obtain this sample at the same time the child is having other routine blood tests.
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ANBL0532, Phase III Study of Single vs. Tandem Myeloablative Consolidation Therapy for High-Risk Neuroblastoma
Patients are being asked to take part in this study because they have high risk neuroblastoma. Neuroblastoma is a type of cancer. Neuroblastoma shows up as a lump or mass in the belly or around the spinal cord in the chest, neck, or pelvis. Neuroblastoma is a cancer of nerve cells. It develops in nerve cells that are outside of the brain. It often spreads to bone, liver, lymph nodes and bone marrow, which is the soft tissue in the center of bones where blood cells are made. Patients in this study have the type of neuroblastoma that is called High Risk because their tumor has spread from where it started or because their type of tumor is harder to treat.

What Is The Current Standard Of Treatment For This Disease?
The treatment for neuroblastoma includes three parts (phases) of therapy called Induction, Consolidation and Maintenance. During Induction therapy anti-cancer drugs (chemotherapy) and surgery are used to kill and remove as much tumor as possible. Blood stem cells are collected during the Induction phase of therapy. After collection the blood stem cells are frozen and stored to be used during the Consolidation phase of treatment. Blood stem cells are the cells that create new blood cells, such as red blood cells, white blood cells, and platelets. Blood stem cells can be collected from the blood by using a machine that can separate out the part of blood that has stem cells and then return the remaining blood back to the patient.

During the Consolidation phase of treatment extremely high doses of chemotherapy are given to better kill any remaining neuroblastoma cells. The extremely high doses of chemotherapy destroy healthy bone marrow. Bone marrow is the soft tissue in the hollow of flat bones of the body that produces new blood cells. The peripheral blood stem cells that were stored during the Induction phase of treatment are given back to the patient after the high dose Consolidation chemotherapy. These stems cells allow the bone marrow to return to normal so that new blood cells can be made. This type of therapy is called a hematopoietic stem cell transplant. Once the patient has healed from the effects of high doses of chemotherapy, radiation therapy is given to the first place the tumor was found and to any additional places where the tumor was found after Induction therapy.

During the third phase of therapy, Maintenance, an oral drug, called cis-retinoic acid (Accutane) is given.
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ARAR0331, "Treatment of Childhood Nasopharyngeal Cancer with Chemotherapy and Chemoradiotherapy"
Patients are being asked to take part in this research study because they have a rare malignant (cancerous) tumor called nasopharyngeal carcinoma (NPC). The tumor is in the nasopharynx, the upper part of the throat behind the nose. Air passes through it to the lungs and food passes through it as it is swallowed. An opening on each side of the nasopharynx leads into an ear.

Because of where it sits, an NPC-type tumor cannot usually be totally removed by surgery. Standard (usual) treatment for people diagnosed very early is radiation therapy only. Others, with more advanced disease get chemotherapy and radiation therapy. These people commonly have larger tumors, or cancer that has spread to the lymph nodes of the neck. This study will use radiation therapy, chemotherapy and chemoradiotherapy.
- Radiation therapy is the use of high-energy x-rays or other types of radiation to kill cancer cells.
- Chemotherapy is the use of anti-cancer drugs to stop the growth of cancer cells.
- Chemoradiotherapy is chemotherapy given at the same time as radiation therapy


Why Is This Study Being Done?
Recent studies done in adults have shown that chemoradiotherapy works better than radiation therapy followed by chemotherapy.

Studies in adults have also shown that the drug amifostine can help prevent the loss of, and thickening of, saliva. This side effect of radiation therapy to the head and neck causes dryness of the mouth which leads to dental problems, problems swallowing and infections.

The goals of this study are:
1) To see if a combination of chemotherapy followed by chemoradiotherapy works better at treating children with advanced NPC than the standard therapy.
2) To see how well amifostine protects children against dry mouth when given daily before radiation therapy.
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ARET0332, A Study of Unilateral Retinoblastoma With and Without High-Risk Features and the Role of Adjuvant Chemotherapy
Patients are being asked to take part in this study because they have unilateral retinoblastoma. Retinoblastoma is an eye cancer which affects young children and is found in the retinal layer of the eye (the back layer of the eye). Unilateral means the disease is in only one eye.


Why Is This Study Being Done?
The purpose of this study is to collect information about patients who have retinoblastoma in only one eye and have had the eye removed. Based on an exam of the eye that was removed, doctors will try to see if the patient is more likely (at high risk) to have the cancer come back. They also hope to find out whether or not chemotherapy keeps the cancer from coming back in patients who are high risk. Patients whose cancer has not spread to other parts of the body are called low risk. Low risk patients will only have surgery and will be carefully watched by the study doctor to see if the cancer spreads to other parts of the body. The research staff hope this information will help them to better treat retinoblastoma.
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Biospecimen Resource for Familial Pancreas Research, a Data and Tissue Registry (also known as a bio-repository, bio-bank, data and tissue database, data and tissue bank, etc.) to Help Advance Research in Familial Pancreas Disease.
The research staff is collecting clinical and family histories, blood and/or tissue samples from family members of patients diagnosed with pancreatic diseases, including pancreatic cancer and melanoma. This will help the researchers to learn whether inherited factors increase the risk of pancreatic diseases, pancreatic cancer, or other cancers. These future studies could involve searching for changes in the genetic material (DNA) taken from blood and/or tissue. The information and samples will be used in future research studies.

Some of the future research studies could involve genetic testing. Because the genetic tests are not used for regular medical care, the patient will not be told the results of the test(s). The test results will not be put in the patient's medical record either.

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Biospecimen Resource for Pancreas Research, a Data & Tissue Bank (also known as a bio-repository, bio-bank, data & tissue database, data & tissue registry, etc.) to Help Advance Research in Pancreas Disease.
This study is being done to develop better ways to screen people at risk for pancreatic conditions, including pancreatic cancer. It is being done to try to find new genes or substances that may make some people more likely to develop pancreatic conditions, and to find agents that may help to prevent, treat, or cure them.

The research staff is collecting clinical and family histories, blood and/or tissue samples from patients diagnosed with pancreatic diseases, including pancreatic cancer. This will help the researchers to learn whether inherited factors increase the risk of pancreatic diseases, pancreatic cancer, or other cancers. These studies will involve searching for changes in the genetic material (DNA) taken from blood and/or tissue. The information and samples will be used in current and future research studies.

Some of the future research studies could involve genetic testing. Because the genetic tests are not used for regular medical care, patients will not be told the results of the test(s). The test results will not be put in the patient's medical record either.
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Bisphosphonates as Treatment in Breast Cancer (S0307)
This study is investigational and is being done to find out if adding a drug (a bisphosphonate) to hormonal therapy or chemotherapy will help prevent cancer from spreading to the bones or other parts of the body. Bisphosphonates are a group of drugs that have strong effects on the bones and have been shown to strengthen the bones in many patients who take them. This study will compare three study drugs, ibandronate, clodronate, and zoledronic acid in breast cancer.
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CA190002: A Phase I/ II, Ascending Multiple-Dose Study to Evaluate the Safety and Pharmacokinetics of BMS-753493 in Patients with Advanced Cancer
Patients are being asked to take part in this research study because they have been diagnosed with advanced cancer.

The Purpose of the study is:
- To determine the highest tolerated dose of a new investigational drug called BMS-753493 in patients with advanced cancer.
- Evaluate the effect (good or bad) and the safety of the drug, and measure the levels of the drug in the blood at various times throughout the study.
- Look at the effect of drug on certain cancers (ovarian, renal and breast).

BMS-753493 is a drug that has two parts that work together to get rid of the patient's cancer. The first part, called "folate" guides the drug to the cancer cells. The second part of the drug, called "epothilone", is the part of the drug that is designed to kills the cancer cells. Studies in animals and humans have shown that some cancer cells express the folate receptor on their surface. This means that the folate can find these cells and then guide the epothilone to these unhealthy cells to do its work. This will hopefully reduce side effects by keeping the epothilone away from healthy cells that do not contain the folate receptors.
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CCI-779 (Temsirolimus) and Temozolomide (Temodar) in Combination with Radiation Therapy in Patients with Glioblastoma Multiforme (GBM)
This study is being done to:
-Add CCI-779 to the standard treatment temozolomide (TMZ) and radiation (RT), which is hoped to make the standard treatment better. CCI-779 helps to stop signals that cause tumors to grow.
-Test the safety of the CCI-779 when given in combination with TMZ or in combination with TMZ and RT.
-Find the highest safe dose of CCI-779, an investigational agent, to give with RT and TMZ, which can safely be given without causing bad side effects.
-See what effects (good and bad) it has on the patient and the cancer.
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CHAARTED: ChemoHormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer
This study is being done to:
See if giving docetaxel chemotherapy, at the time a patient is starting hormonal therapy (treatments to lower testosterone) is more helpful than giving it only at the time the hormonal therapy is no longer working.

Hormonal therapy refers to drugs or surgical procedures such as an orchiectomy (removal of testicles) used to lower a patient's testosterone. This puts prostate cancer into remission (cancer has completely or partially gone away) in most patients as testosterone can worsen the cancer. It is the standard treatment for prostate cancer. Normally chemotherapy is reserved for when a patient's cancer starts to grow again despite having a low testosterone level. In this study the patient will either get a chemo therapy drug docetaxel when they start hormonal therapy or when/if their cancer grows with a low testosterone level. If a patient is to have chemotherapy when starting hormones for the first time, they may get chemotherapy when/if their cancer grows back with a low testosterone level.

This protocol is suggesting that a patient's doctor use docetaxel (a type of chemotherapy) if the patient's disease gets worse, even if they had received docetaxel when they started hormone therapy. A patient's doctor may try another hormone treatment before starting them on docetaxel chemotherapy. The reason for this study is to see if getting docetaxel when a patient starts hormone therapy (or within 90 days of starting hormonal therapy) and again, if their disease gets worse, is better than getting docetaxel only at the time the patient's disease gets worse. This study will tell us which way is more effective in treating a patient's disease.
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Chemotherapy (Carboplatin and Isotretinoin) and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor (PNET)
Patients are being asked to take part in this research study because they have been diagnosed with a type of cancer called medulloblastoma, a type of brain tumor. This study is for patients with high risk medulloblastoma. The term, risk, refers to the chance of the cancer coming back after treatment.
One or more of the following factors make the cancer more likely to return after treatment:
- The tumor is not at the very back of the brain
- Some of the tumor was not removed by surgery
- The cancer has spread to more than one site
It is common to enroll children and adolescents with cancer in a clinical trial that seeks to improve cancer treatment over time. Clinical trials include only people who choose to take part. Patients have a choice between a standard treatment for medulloblastoma and this clinical trial.
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Combination Chemotherapy (Methotrexate, Nelarabine) in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia
Acute lymphoblastic leukemia (ALL) is a type of cancer that occurs in the bone marrow. It is a disease in which there is an uncontrolled growth of abnormal white blood cells, referred to as blasts. These abnormal cells crowd out the normal cells in the bone marrow. Sometimes these blasts cells can be found in the brain, spinal cord, and/or other organs of the body. It is common to enroll children and adolescents with cancer in a clinical trial that seeks to improve cancer treatment over time. Clinical trials include only people who choose to take part. You have a choice between a standard treatment for T-cell ALL and this clinical trial.

What Is The Current Standard Of Treatment For This Disease?
In the first stage, called Induction, the medical team tries to remove all visible signs of leukemia and allow normal blood cells to be restored (this is called remission). Six chemotherapy drugs are used during this stage of treatment. The leukemia treatment is the same for patients who choose to be on this study and those who do not.

The following is detailed information on the current standard of Induction therapy:

Standard Treatments and Procedures for Patients with T cell ALL

Central Line
For drugs to be given by vein, the doctor will likely recommend that the patient have a central venous line placed.

Methods for Giving Drugs
Various methods will be used to give drugs to patients.
- PO - Drug is given by tablet or liquid swallowed through the mouth.
- IV - Drug is given using a needle or tubing inserted into a vein. It can be given by IV push over several minutes or by infusion over minutes or hours.
- IM - Drug is given using a needle injected into the muscle.
- SQ - Drug is given by injecting a needle into the tissue just under the skin.
- IT - Drug used to treat the brain and spinal cord is given using a needle inserted into the fluid surrounding the spinal cord.

Most drugs used on this study will be given using a needle or tubing inserted into the vein (IV).

Therapy for patients on all treatment plans:
The purpose of Induction therapy is to kill as many of the leukemia cells as possible so the disease goes into remission.

Drugs/ How the drug will be given/ Days
Cytarabine IV or SQ Day 1
Vincristine IV Days 1, 8, 15, 22
Prednisone PO or IV Days 1 - 28
Daunorubicin IV Days 1, 8, 15, 22
PEG Asparaginase* IM Days 4 [or 5 or 6]
Methotrexate** IT Days 8, 29
Leucovorin (patients with Down syndrome ONLY) PO 48 and 60 hours following each IT MTX

*If patients develop an allergy to PEG asparaginase, six injections of a different form of asparaginase (called Crisantaspase) may be substituted for each dose of PEG asparaginase

**If patients have leukemia in the spinal fluid of the first spinal tap they may also get methotrexate on Days 15 and 22


Standard tests and procedures
The following tests and procedures are part of regular cancer care and may be done even if the patient does not join the study.
- Physical exams
- Frequent labs to monitor blood counts and blood chemistries
- Urine tests to measure how the kidneys are functioning
- Pregnancy test for females of childbearing age before treatment begins
- X-rays and scans to monitor the patient's response to treatment
- Tests to monitor heart and lung functioning
- Bone marrow aspirations to see if the leukemia is responding to treatment
- Spinal taps to check for leukemia cells in the spinal fluid and to give chemotherapy into the spinal fluid

Measurement of Early Response to Treatment
During Induction therapy, tests will be done on the patient's bone marrow samples to let the researchers know how well the patient is responding to treatment. Two types of tests will be done.
1. The patient's local hospital laboratory will perform standard tests to measure how much leukemia is still left.
2. The central Children's Oncology Group (COG) laboratory will use a specialized test to measure minimal residual disease. This test detects numbers of leukemia cells that are too small to be seen by human eyes.

Using the results of these tests, in combination with the patient's age and white blood cell count at diagnosis and whether or not the patient had leukemia in their spinal fluid or testicles, researchers will then be able to place the patient into one of four categories:

1. Low Risk: These patients are less than 10 years old and have a white blood cell count of less than 50,000 at diagnosis, without evidence of testicular disease or leukemia in the central nervous system. In addition, these patients have very few or no leukemia cells in the bone marrow tested in your local hospital by Day 8 or Day 15 and there is little minimal residual disease found in the bone marrow tested at the COG laboratory from Day 29. Low Risk patients will not take part in the study of the new drug, nelarabine, nor will they receive radiation therapy since they are expected to do well with standard treatment.
2. Intermediate Risk: This group included all of those patients who do not meet criteria or fit the definition for Low Risk, High Risk or patients who still have T cell leukemia at the end of Induction.
3. High Risk: Regardless of any other features or test results, these patients have 5 percent to 25 percent blasts visible under the microscope on Day 29 of Induction therapy OR more than 1 percent blasts detected by a special test for minimal residual disease (MRD).
4. Patients with T cell leukemia at the end of Induction: Regardless of any other features or tests results, these patients have more than 25 percent blasts visible under the microscope on Day 29 of Induction therapy.

The term "risk" refers to the chance of the cancer coming back after treatment. Once the researchers have measured the patient's early response to treatment, they will be able to find out which of these risk categories of T cell ALL the patient belongs to. This will help determine the amount of chemotherapy the patient will need for the second part of the treatment.
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Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia (ALL) That Has Relapsed in the Central Nervous System (CNS) or Testes
This study is being done to see if stronger chemotherapy (anti-cancer drugs) used with less radiation therapy can bring about a remission (make the cancer go away).
Patients are being asked to take part in this study because they have acute lymphoblastic leukemia (ALL). At least 18 months have passed since they were first diagnosed with ALL. The leukemia had gone away (been in remission) but now it has returned (relapsed). The leukemia returned in their central nervous system (brain and spinal cord) and the testes.
The research staff know that radiation therapy can cause long-term side effects (side effects are unintended physical reactions to the drugs that are unrelated to the reasons the drugs are being used). The researchers hope to find out if this study treatment will still make the same high rates of remission that are seen with standard treatment but cause less long-term side effects. In addition to these treatment aims, the research staff would like to use information collected on this study to answer some research questions that might help future patients. Patients can choose to be on this clinical trial without taking part in this piece of the research.

The research aims are as follows:
- See if tiny amounts of leukemia cells might be present in the bone marrow (the soft tissue in the hollow of flat bones of the body that makes new blood cells) at the time of relapse (study entry). Researchers want to know if the amount of these cells can tell the research staff how well a patient might respond to treatment.
- Look for changes in the genetic structure (DNA) of relapsed patients. The research staff want to see if genetic changes make a difference in how the patient responds to treatment and in the types of side effects the patient has while being treated.
- Look at the effects that the disease and treatment have on thinking, learning, and behavior. The research staff want to know if patients have fewer learning and other psychological problems if less CNS radiation therapy is given.
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Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation, Radiation Therapy, and/or Surgery in Treating Patients With Ewing Sarcoma
This study is being done to:
- Improve the outcome of patients with Ewing sarcoma.
- Compare the survival of patients in a study of:
- standard drug treatment and whole lung irradiation versus
- high dose, stronger drug treatment followed by replacement of peripheral blood stem cells (transplant). Stem cells are the cells that create new blood cells, such as red blood cells, white blood cells, and platelets. They can be found in the peripheral blood (bloodstream) or the soft tissue of the bone, called the bone marrow.

Patients are being asked to take part in this study because they have a type of cancer called Ewing sarcoma that has spread to the lung or pleura (lining of the lung and chest cavity).
Ewing sarcoma is a cancerous tumor that forms in the bone or soft connective tissues.
These tumors spread quickly to other areas of the body including the lungs. Ewing
sarcoma is always fatal without treatment.

The standard treatment for patients with Ewing sarcoma with disease that has spread to the lungs or pleura is standard dose chemotherapy and whole lung radiation therapy. It is possible that stronger chemotherapy, using high doses of standard chemotherapy drugs may improve the outcome (survival) for these patients. However, the side effects of using both whole lung radiation therapy and high dose chemotherapy would be too much to combine these treatments.
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Combined Chemotherapy and Hormone Therapy for Individuals with a Low Risk of Cancer Recurrence after Ten Years: The TAILORx Trial
This study is being done to:
- Determine whether patients who have a tumor with a 10 percent chance of their tumor
recurring (coming back following treatment) after 10 years benefit from
chemotherapy
- Determine whether patients who have a 5 percent chance of their tumor recurring
(coming back following treatment) after 10 years have a very low risk of recurrence with hormonal therapy alone (and do not need chemotherapy to reduce their risk of recurrence)
- Create a tissue and blood specimen bank that includes specimens from all women who participate in this study
- Collect follow-up information regarding the health status of all women who
participate in the study for 20 years in order to evaluate new diagnostic tests in the
future as they develop that may predict benefit or side effects from certain cancer
treatments.
Patients are being asked to take part in this trial because they have breast cancer that is estrogen receptor and/or progesterone receptor positive that has not spread to the auxiliary lymph nodes. Although the patients have received surgical treatment for their cancer, there is a chance that they may have a future recurrence of the cancer in the breast, chest wall, or other parts of their body. Based on researchers' current knowledge about the treatment of breast cancer, the doctors believe that patients in this study are candidates for chemotherapy in addition to hormonal therapy in order to reduce their risk of recurrence, a recommendation that is consistent with established guidelines for treatment of this type of breast cancer.
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Comparison of Types of Radiation Techniques for Women with Early Stages of Breast Cancer (B-39)
Studies have shown that giving radiation therapy to the breast after lumpectomy helps keep cancer from coming back in the breast. The purpose of this study is to see if partial breast irradiation (PBI) is as good as or better than whole breast irradiation (WBI) in keeping cancer from coming back in the breast. WBI is a standard treatment after a lumpectomy. WBI is radiation therapy given 5 days a week for 5 to 7 weeks to the whole breast. PBI is radiation therapy given only to the area of the breast where the cancer was removed. PBI is given 2 times a day on 5 days. PBI may be given over a period of 5 to 10 days. There are 2 different methods of PBI that are being used in this study: multi-catheter brachytherapy and 3-D conformal external beam irradiation.
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Daily Oral Polyphenon E in Asymptomatic Rai Stage 0-II Patients with Chronic Lymphocytic Leukemia (MC0419)
This research study is being done to:

• test the effects (good and bad) of an extract of green tea (called polyphenon E) on patients who have chronic lymphocytic leukemia (CLL);
• find the highest dose of polyphenon E that can be given without causing unacceptable bad side effects;
• learn how the body handles or processes polyphenon E and polyphenon Es other effects in the body using blood and bone marrow samples.

There is no approved treatment for patients who don't have obvious signs or symptoms of their early stage CLL, despite the fact that the cancer gets worse in many patients with this illness, and in time will require treatment for it.
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E2805, Phase 3 Trial of Sunitinib (Sutent) versus Sorafenib (Nexavar) versus Placebo in Patients with Resected (Surgically Removed) Renal Cell Carcinoma
The purpose of this study is to see if either Sunitinib or Sorafenib can prevent recurrence of a patient's kidney cancer and to compare the effects (both good and bad) of the Sunitinib and the Sorafenib with placebo (pills that look like the study drugs, but are not active or do not contain the drug) on the patient and their kidney cancer to see which is better.
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Estrogen-DNA Adducts in Breast, Urine and Serum (Blood) as Biomarkers of Breast Cancer Risk
This study is being done to:

Low/ Average Risk Patients:
1. Measure the level of certain hormones, enzymes and cellular products in urine and serum (blood) samples obtained from women who are low or average risk for developing breast cancer
2. Determine whether the level of these products present in urine and blood samples may be related to risk of developing breast cancer

High Risk/ Recently Diagnosed Breast Cancer Patients
1. Measure the level of certain hormones, enzymes and cellular products in breast nipple fluid samples, urine and serum (blood) samples obtained from women who are high risk for developing breast cancer and in women with a recent new diagnosis of breast cancer
2. Determine whether the level of these products present in urine, blood, and nipple fluid samples may be related to risk of developing breast cancer
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Evaluating the Role of Exemestane Plus GnRH Analogue as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer (IBCSG 25-02)
This research study is being done to:

• see if the combination of ovarian function suppression using a GnRH analogue plus tamoxifen is better at stopping the return of breast cancer than the combination of ovarian function suppression using a GnRH analogue plus exemestane;
• compare the effects (good and bad) of exemestane to the effects of tamoxifen.
• see how the treatment affects how well the patient feels.
• see if there are any effects (good and bad) that happen after treatment has stopped.

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Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane Adjuvant Therapies for Pre-Menopausal Women with Endocrine Responsive Breast Cancer (IBCSG 24-02)
This research study is being done to:

• see if ovarian function suppression [OFS] plus giving tamoxifen or exemestane is better at stopping the return of breast cancer than just giving tamoxifen in pre-menopausal women. Ovarian function suppression [OFS] shuts down the ovaries and stops them from making hormones such as estrogen.
• see if a newer hormone drug called exemestane plus OFS is better than tamoxifen plus OFS.
• see what are the good and bad side effects of the treatment.
• see how the treatment affects how well the patient feels.
• see if there are any effects (good and bad) that happen after treatment has stopped.

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Flavopiridol and Cisplatin in Advanced Epithelial Ovarian and Primary Peritoneal Cancers (MC0261)
This research study is being done to learn the effects (good and bad) of the drugs flavopiridol and cisplatin when given together to patients with ovarian and primary peritoneal cancer.
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Gene Analysis for the Understanding of Barrett's Esophagus and Esophagus Cancer
This study is being done to advance the understanding of how esophagus cancer and Barrett's Esophagus develop as well as ways to treat these conditions. This will be done by analyzing blood and tissue to identify genes that may be involved in the development of esophagus cancer and Barrett's Esophagus.
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Genetic Epidemiology of B-Cell Lymphoproliferative Disorders
The major purpose of this research study is to understand how genetic and environmental exposures contribute to the development of blood or lymph node cancer. This study will improve our understanding of what causes blood or lymph node cancers.

In addition, we hope this study will lead to ways to detect such cancers early, and perhaps, even to prevent them. Patients are asked to participate because either they or a family member is known or thought to have blood or lymph node cancer. There is some evidence that a personal or family history or environmental exposures may increase a person's chances of having a blood or lymph node cancer.
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Genetics Study for Women with Breast Cancer and Starting Anastrozole (Arimidex) Treatment (MC0532)
This study is being done to examine how a woman's genes affect the way her body responds to anastrozole treatment. Researchers will look at changes in hormone levels, bone density and mammograms.
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GOG-0215, A Phase 2 Study Evaluating Bone Mineral Density in Individuals Having Removal of the Ovaries to Prevent Ovarian Cancer, Receiving Either Zoledronic Acid (Zometa) or Observation
The purpose of this study is to look at the effects of zoledronic acid (Zometa) on preventing bone loss in women who undergo early menopause due to surgical removal of their ovaries. Women who choose to have their ovaries removed before menopause will experience immediate menopause due to the loss of estrogen in the body. A lack of estrogen can cause a variety of side effects, one of which is bone loss. Substantial bone loss can lead to a higher risk of bone fractures. This study is being conducted to find a way to prevent the loss of bone in women who have chosen to undergo this surgery.
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GOG-0219, A Phase III, Randomized Study of Weekly Cisplatin and Radiation versus Cisplatin and Tirapazamine (IND #46525) and Radiation in Stage IB2, IIA, IIB, IIIB and IVA Cervical Cancer Limited to the Pelvis
Patients are being asked to take part in this research study because they have cancer of the cervix. This study is being done to determine if combining Tirapazamine (TPZ) with Cisplatin during radiation therapy increases the amount of time until a patient's cancer returns compared with Cisplatin and radiation therapy alone.

The Tirapazamine (TPZ) used in this study is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA) for either routine clinical use or for the use described in this study. However, the FDA has allowed the use of this drug in this research study.
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H23750, The Effect of Diflunisal (Dolobid) (IND 68092) On Familial Amyloidosis: A randomized, double blind, placebo controlled, international multi-center trial of Diflunisal on neurologic disease progression in 200 familial amyloidal patients
Patients are being asked to participate in this research study because they have been diagnosed with Familial Amyloid Polyneuropathy (FAP) and have symptoms of nerve and/or heart damage. FAP is an inherited disease that attacks the nerves and heart, generally causing death 7-15 years after diagnosis. At present, the only treatment for FAP is liver transplantation.

Medicines are needed to treat this disease. A common anti-inflammatory drug called diflunisal (Dolobid) that is similar to Motrin has been shown to prevent amyloid formation in a test tube and in the blood of normal human volunteers. The research staff would like to find out if diflunisal stops amyloid production in patients with FAP. All patients participating in the study will be encouraged to seek liver transplantation. Patients pursuing liver transplantation will be welcomed into the study provided the operation is unlikely to be performed within 12 months of entering the study based on the status of the liver transplant waiting list. Participation in this study will not affect the patient's current status on a liver transplant waiting list, nor future listing for transplantation.

This research study is designed to establish whether diflunisal, an anti-inflammatory drug that has been used for over 20 years in patients with arthritis, can stop nerve and heart damage resulting from amyloid produced by patients with FAP. Researchers know that diflunisal prevents formation of amyloid in the test tube. This study will determine if diflunisal can block amyloid production in FAP patients.
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Imaging Cells in Monoclonal Antibody Therapy for Lymphoma
This study is being done to learn about how and/or why Rituxan works in the body. It is designed to help to find out how cancer-fighting cells in the body move into the tumor before and after Rituxan is given
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Immunosuppressant, Alefacept (Amevive), in the Treatment of Cutaneous T-Cell Lymphoma and Peripheral T-Cell Non-Hodgkin Lymphoma (LS058C)
This study is being done to test the safety of alefecept (Amevive) and see what effects (good and bad) it has on the patient and lymphoma. The study will find the best dose of alefacept (Amevive) that will produce response in the tumor without causing severe side effects. This research is being done so researchers can find better treatments for people with T-cell lymphoma.
This research study is being done by the Lymphoma SPORE (Specialized Program of Research Excellence). The Lymphoma SPORE is a group of 2 health care centers, Mayo Clinic Rochester and the University of Iowa, that have joined together to research lymphoma and lymphoma treatments. For this study, Mayo Clinic Rochester and the University of Iowa are working with other institutions (City of Hope and John Hopkins) who have been awarded SPORE grants from the NCI. The SPORE is supported by the National Cancer Institute. Mayo Clinic Rochester is the coordinating site for the SPORE.
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Intensive Treatment for Intermediate-Risk Relapse of Childhood B-Precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies
Patients have been treated in the past for a cancer of the blood cells called acute lymphoblastic leukemia (ALL). Patients are being asked to take part in this study because the leukemia has come back (relapsed) and is of intermediate risk. The term "risk" refers to the chance of the cancer coming back again after treatment for this relapse. The patient's leukemia is defined as "intermediate risk" because one of the following apply:
-The leukemia returned in their bone marrow (with or without leukemia in
other parts of their body) 3 years or more after they were first diagnosed
with ALL.
-The leukemia returned in the patient's central nervous system (spinal fluid) and/or the testes (but not in the bone marrow) less than 18 months after they were first diagnosed with ALL.

It is common to enroll children and adolescents with cancer in a clinical trial that seeks to
improve cancer treatment over time. Clinical trials include only people who choose to
take part. Many different chemotherapy treatment programs have been used for children with intermediate risk relapse of ALL, and there is no real standard treatment at this time. Patients have a choice between other treatments for ALL and this clinical trial.

What Is The Current Standard Of Treatment For This Disease?
There is no generally accepted standard treatment for intermediate risk relapse of ALL at this time. Combination chemotherapy has been the main treatment for children with intermediate risk relapsed ALL. Several studies have used various combinations and had similar outcomes in the number of children treated successfully.

The first month of treatment usually involves chemotherapy very similar to that given to treat ALL for the first time. Children with intermediate risk relapse have an excellent chance of going into a second remission (disappearance of all signs and symptoms of ALL).
However, the risk that the leukemia will come back after getting into remission is definitely higher than it was when the patient was first diagnosed with ALL. Because of this, the treatment that is given for relapse is more intensive (stronger) than that given to treat ALL for the first time. Like the first treatment for ALL, treatment for intermediate risk relapse has several phases. All phases of treatment are very important. The total length of chemotherapy treatment used for intermediate risk relapse varies from about 1.5 to 2.5 years in most cases.

Some doctors also recommend bone marrow (stem cell) transplants for some children and adolescents with intermediate risk relapse. This study will recommend bone marrow transplant for children with intermediate risk relapse that go into a second remission and have a matched family donor. About 20 to 30 percent of patients will have a close match. This use of bone marrow transplant is considered to be a valid treatment. Also, radiation therapy is sometimes used in relapsed ALL, especially if the relapse involves organs such as the brain or testes.

Why Is This Study Being Done?
Since there is no standard treatment regimen for children with intermediate risk relapse of ALL, the major goal of this study is to establish an effective therapy. The study treatment plan is based on an earlier plan (?POG 9412?) which showed a good effect in children who had a relapse of ALL in the brain. In this study, the treatment will be strengthened by giving higher doses of chemotherapy drugs more often. This study is to determine how effective this treatment is for all types of intermediate risk relapse.

Patients received vincristine during their first treatment for ALL, and it is part of treatments commonly used for relapsed ALL. The standard dose of vincristine is 1.5 milligrams/square meter (mg/m2)with a maximum dose of 2 mg. Higher doses of vincristine have been used to treat children with other forms of cancer and a recent Dutch trial has also used a higher dose to treat children with ALL. The researchers want to see if a higher dose of vincristine (2 mg/m2 with a maximum dose of 2.5 mg) can get rid of the cancer for as long as possible in more patients with relapsed ALL.


Researchers want to compare the effects, good and/or bad, of chemotherapy with a high dose of vincristine against chemotherapy with a standard dose of vincristine. The research staff want to find out which dose is better. In this study, patients will get either the high dose of vincristine or the standard dose of vincristine. Patients will not get both.

The goals of this study are:
1) To find out the effectiveness and side effects of the high dose combination chemotherapy treatment for all patients on this study.
2) To find out the effectiveness and side effects of higher dose vincristine compared to standard dose vincristine.

In addition to the treatment goals, researchers would like to use specimens collected on this study to answer some research questions that might benefit future patients. Patients can choose to be in this clinical trial without taking part in this research portion.

One of the biology research goals involves a test to measure minimal residual disease (MRD). This test measures numbers of leukemia cells that are too small to be counted using traditional methods. Researchers will use it to find out if leukemia is still present in the bone marrow. The research staff also want to study the genetic make-up of the cancer cells to try to learn about why people get cancer and if the genes in the cancer cells can predict how someone will respond to treatment.

Biology Research Goals (Optional Participation):
1) To find out if MRD levels can be used to tell how well a patient with relapsed ALL is responding to treatment. Researchers also want to find out if high MRD levels can be used to identify people at higher risk of another relapse.
2) To study genetic changes, and patterns within the genes of the leukemia cells. The research staff hope to learn more about disease resistance and find out if they can predict how well someone will respond to chemotherapy.
3) To find out if a) differences that occur naturally in genes (polymorphisms) might be part of the reason why some people develop leukemia and b) if those differences influence why some patients have certain side effects with treatment.

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Irinotecan (CPT-11) and/or Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer (N0147)
This research study is being done in patients who have had surgery for colon cancer to: Find out the effectiveness of the following six different combinations of drugs in stopping the return of your colon cancer these treatments, namely cetuximab (C225), irinotecan (CPT-11) and oxaliplatin (OXAL), are considered investigational in the stage of colon cancer that you have. These drugs are given in combination with standard chemotherapy drugs called 5-fluorouracil (5-FU) and leucovorin (CF).
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MC0482, Phase III Study of Stem Cell Transplantation Compared to Parenteral Melphalan and Oral Dexamethasone in the Treatment of Primary Systemic Amyloidosis (AL)
This study is being done to determine whether the response rate is different for patients who receive melphalan in one dose followed by stem cell vs. the same total dose of melphalan given over ten doses with six weeks between each dose.
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MC057H - A Phase II Study of GW 786034 (Pazopanib) in Advanced Thyroid Cancer
Patients are being asked to take part in this research study because they have metastatic medullary, anaplastic, or advanced differentiated thyroid carcinoma. This study is being done to learn what effects (good and bad) GW786034 has on the patient and their: metastatic medullary, anaplastic, or advanced differentiated thyroid carcinoma.
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MC0677, B7-DC XAb Plasma Therapy for the Treatment of Metastatic Melanoma. A Feasibility/Pilot Study
Patients are being asked to take part in this research study because they have been diagnosed with metastatic melanoma and they are a candidate for plasma therapy. This treatment uses an antibody taken from a patient that appears to activate the immune system against melanoma.
The study drug is a small sample of the patient's plasma containing the antibody B7-DC XAb. The antibody was discovered for its ability to stimulate the immune system in a way in which the body would become aware of the presence of the cancer. The molecule will bind receptors on the surface of immune cells and stimulate anti-tumor immunity. The researchers can measure the results of this change in the peripheral blood (blood from a vein) as well as look to see if this will reduce the size of the tumors.
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MC0784, Phase II Trial of Pentostatin, Cyclophosphamide, and Rituximab (Rituxan) followed by Consolidation with Lenalidomide (Revlimid) for Previously Untreated B-Cell Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Patients are being asked to take part in this research study because they have previously untreated B-cell Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). This study is being done to learn about the effectiveness and side effects of pentostatin, cyclophosphamide and rituximab (PCR) followed by lenalidomide for previously untreated CLL/SLL and to learn whether lenalidomide treatment after treatment with PCR can eliminate residual CLL/SLL that remains after PCR.
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MC078B, A Phase I/II, Prospective, Open-Label Study to Determine the Safety and Efficacy of CC-4047 (Actimid) in Patients with Primary, Post Polycythemia Vera, or Post Essential Thrombocythemia Myelofibrosis
Patients are being asked to participate in this research study because they have been diagnosed with primary, post polycythemia vera or post essential thrombocythemia myelofibrosis. CC-4047 is a medicine that is chemically similar to a drug called thalidomide. This study is being done to test the safety of CC-4047 and to see what effects (good and bad) it has on patients and their disease.
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Measles Virus Derivative Producing CEA (MV-CEA) in Patients with Recurrent Glioblastoma Multiforme (GBM)
This research study is being done to:

• Test the safety of the measles virus, MV-CEA, and see what effects (good and bad) it has on you and your brain cancer
• Find the highest dose of MV-CEA that can be given without causing bad side effects
• Find out how the tumor and your cells respond to the MV-CEA
• Test levels of CEA in your blood at different doses of MV-CEA
• Test for the presence of measles virus in your body after you are given MV-CEA

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Monoclonal Antibody, Bevacizumab (Avastin), for Treating Angiosarcoma (NU04S1)
This research study involves the use of a drug called Bevacizumab. Bevacizumab is currently approved by the Food and Drug Administration (FDA) as a treatment for patients with metastatic colon cancer. It is not approved as a treatment for angiosarcoma, so it is considered experimental in this study. Bevacizumab works by blocking a substance in a persons body called endothelial growth factor, or VEGF. VEGF is found in many normal tissues and is important in the making of new blood vessels (both normal and abnormal) in a persons body. Cancerous tumors may cause too much VEGF to be made. This study is being done to find out what effects (good and bad) Bevacizumab has on a patient and angiosarcoma; find out what side effects this drug causes and how often they happen.
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N057K, Phase I/II Evaluation of Everolimus (RAD001, Certican), Radiation and Temozolomide (Temodar, TMZ) Followed by Adjuvant Temozolomide and Everolimus in Newly Diagnosed Glioblastoma (GBM)
The purpose of this research study is to:
- Add the study drug everolimus to the standard treatment of temozolomide and radiation to see if this addition makes the standard treatment better. Everolimus helps to stop signals that cause tumors to grow. Everolimus is an investigational drug and is currently not approved for use in brain tumors.
- Test the safety of the everolimus when given in combination with temozolomide.
- Find the highest safe dose of everolimus in combination with temozolomide after radiation is complete that can safely be given without causing bad side effects.
- See what effects (good and bad) it has on patients and their cancer.
- Test whether changes on a research FDG PET/CT or FDG PET scan can predict a response to everolimus therapy. FDG is a radioactive chemical that is injected into a patient's vein before the scan and is an imaging agent routinely used throughout the country.
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N0682, A Phase II Study of Denileukin Diftitox in Combination with Rituximab (Rituxan) in Previously Untreated Follicular B-cell Non-Hodgkin Lymphoma Patients
Patients are being asked to take part in this research study because they have follicular B-cell Non-Hodgkin lymphoma and have not had any chemotherapy or radiation treatment.
This research study is being done to find out what effects, good and/or bad, the drug denileukin diftitox combined with rituximab has on the patient and their follicular B-cell Non-Hodgkin lymphoma.

It is important to realize that while rituximab is frequently used as initial treatment for
this type of lymphoma, chemotherapy is also often used in combination with rituximab as
the first treatment for follicular lymphoma. Treatment with chemotherapy plus rituximab may result in more patients responding to treatment and for a longer time, but also in more side effects.

While doctors hope rituximab and denileukin diftitox will be more useful against cancer compared to rituximab alone or rituximab in combination with chemotherapy drugs, there is no proof of this yet.
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Optimizing Treatment Strategies for Surgically Treatable Osteosarcoma, Based on Response to Pre-operative Chemotherapy.
Study doctors would like to find out how best to treat subjects with osteosarcoma by comparing how subjects do when treated with different anti-cancer drugs. The standard anti-cancer drugs used to treat subjects with osteosarcoma are methotrexate, doxorubicin (also called adriamycin) and cisplatin. These three drugs together are called MAP. This study is being done to:
- See if adding ifosfamide and etoposide (VP-16) to chemotherapy will help get rid of the disease in subjects who have a poor tumor response to MAP alone.
- See if adding a "biologic" drug called interferon after MAP chemotherapy can help get rid of the disease in subjects who have a good tumor response to standard chemotherapy. This study will use pegylated interferon alfa-2b, interferon that has been changed to last longer in the body so it can be given less often.
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Pentostatin, Cyclophosphamide and Rituximab (PCR) Followed by Campath-1H for Previously Treated Relapsed or Refractory Patients with Chronic Lymphocytic Leukemia
This research study is being done to see if patients who are treated with this drug combination will go into remission (a complete or partial disappearance of the disease), and if the remission will be maintained with CAMPATH-1H treatment.
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Phase 3 Study of Chimeric Antibody 14.18 (Ch14.18) in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue
Neuroblastoma is a solid, cancerous tumor that shows up as a lump or mass in the belly or around the spinal cord in the chest, neck, or pelvis. The standard treatment for neuroblastoma consists of anti-cancer drugs (chemotherapy), surgery, and radiation therapy. Children with high-risk neuroblastoma often respond to standard treatment at first, but there is a high risk that the cancer will come back. This study is being done to try to raise the number of children with high-risk neuroblastoma who can avoid having the cancer come back.

Prior to taking part in this study patients would have already had chemotherapy, surgery, radiation therapy, and stem cell transplant treatment. Patients were helped by this treatment.
The reason for this companion study is to compare two different treatments aimed at keeping or improving their response to previous treatments. This study involves the use of an investigational biologic therapy, ch14.18, a monoclonal antibody. Monoclonal antibodies are proteins made in the laboratory, designed to bind to specific cancer cells. ch14.18 was designed to bind to neuroblastoma cells and other cancer cells that express the GD-2 antigen. When ch14.18 binds to the neuroblastoma cells, the body's immune system is excited to attack and kill the neuroblastoma cells. Ch14.18 represents a new kind of cancer therapy that, unlike chemotherapy and radiation, targets the death of cancer cells without killing nearby healthy cells. There is laboratory proof to suggest that ch14.18 can target the body's own immune cells to get rid of cancer cells. These immune cells armed by ch14.18 include cells that are activated by GM-CSF and cells turned on by aldesleukin (IL-2). Prior studies had shown the safest doses of ch14.18 and IL-2 to be given after stem cell transplant.

GM-CSF and IL-2 are drugs that are like a fluid made by the body in everybody. Usually the body makes small amounts of GM-CSF that helps it to produce normal infection fighting white blood cells. The body also makes small amounts of IL-2 that helps white blood cells fight infection. It is now possible to make GM-CSF and IL-2 outside of the body and give humans much higher doses than their own body makes. There is some proof that, in the laboratory and in animals, GM-CSF and IL-2 raises the anti-cancer effect of monoclonal antibodies like ch14.18. The research staff wish to see if aldesleukin (IL-2) can help improve the helpfulness of ch14.18 in humans.
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Phase 3 Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) versus VAC Alternating with Vincristine and Irinotecan (VI) for Patients with Intermediate-Risk Rhabdomyosarcoma (RMS)
The current standard treatment for rhabdomyosarcoma (RMS) is surgery to remove as much tumor as possible, chemotherapy (anti-drug therapy) with vincristine, dactinomycin and cyclophosphamide (together called VAC therapy), and, for almost all tumors, radiation therapy (treatment with high energy X-rays).
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Phase 3 Trial of Irinotecan-Based Chemotherapy Plus Cetuximab (Erbitux) with or without Bevacizumab (Avastin) as Second-Line Therapy for Patients With Metastatic Colorectal Cancer who Have Progressed on Bevacizumab with either FOLFOX, OPTIMOX, or XELOX
The purpose of this study is to find out if the addition of bevacizumab improves response and survival.

Bevacizumab is the common name for the commercial drug Avastin. The bevacizumab used in this trial, however, is for use in research studies only and may be made at locations different from those where Avastin is made. Although some differences may exist, bevacizumab for research use and the commercial drug, Avastin, are manufactured by a similar process, meet similar standards for final product testing, and are expected to be very similar in safety and effectiveness.
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Phase 3 Trial of Maintenance Chemotherapy Comparing 12, Monthly Cycles of Paclitaxel or Xyotax (CT-2103) (IND#70177), Versus No Treatment Until Documented Relapse In Women with Advanced Ovarian or Primary Peritoneal Cancer Who Achieve A Complete Clinical Response to Primary Platinum/Taxane Chemotherapy
Patients are being asked to take part in this research study because they have ovarian or primary peritoneal cancer that has been confirmed by surgery. The patient's physician has told the patient that chemotherapy (treatment with a drug) is needed to control the growth of the tumor and reduce the chance of recurrence (coming back). Standard chemotherapy for the patient's cancer is effective, but a long-term cure is uncommon. Many patients will eventually redevelop disease and need additional treatment. It is hoped that new chemotherapy combinations may improve on the success achieved with current standard treatment programs.

A recently completed study showed that women with advanced ovarian cancer who had no sign of active disease after the completion of the initial five or six cycles (periods of treatment and rest) of chemotherapy who continued to receive chemotherapy had a delay in the return of their cancer. Unfortunately, in this trial it was not possible to determine if the delay in the return of their cancer was associated with an improvement in how long they lived. A second question that was not answered by this completed study was whether the benefit of the delay in the return of their cancer was outweighed by the side effects of continuing the chemotherapy.

In the current trial the researchers wish to examine whether women with advanced ovarian cancer who have no evidence of disease after the completion of initial chemotherapy live longer if a specific treatment program is continued once a month for 12 months versus stopping all chemotherapy until there is evidence of return of the cancer. Two different chemotherapy regimens (plans of treatment) and one regimen including no further treatment will be examined. The first of the chemotherapy arms, paclitaxel, is a standard chemotherapy drug used to treat ovarian cancer, and was the drug utilized in the trial noted above. The second drug, Xyotax (CT-2103), is an experimental drug with anticancer activity similar to that of paclitaxel. It is possible that CT-2103 will produce similar results to that found with paclitaxel, but with reduced side effects. Patients will be randomized (like the flipping of a coin) to one of the three possible regimens (paclitaxel, CT-2103 or check-ups only) . Patients have an equal chance of being placed in any one of the three regimens. Neither the patient nor the doctor will decide which regimen is received.
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Phase I Dose-Escalating, Open-Label, Non-Placebo Controlled Study of BAY 43-9006 (sorafenib, Nexavar) in Combination with Carboplatin, Paclitaxel (Taxol) and Bevacizumab (Avastin) in Previously Untreated Patients with Stage IIIB (with malignant pleural effusions) or Stage IV Non-Small Cell Lung Cancer (NSCLC)
This study is being done to learn:
-About the side effects (good or bad) of BAY 43-9006 (Sorafenib), carboplatin, paclitaxel and bevacizumab when given together;
-The highest safe dose of the cancer drug called BAY 43-9006 that can be given with carboplatin, paclitaxel and bevacizumab to patients with advanced nonsmall cell lung cancer;
-If BAY 43-9006, carboplatin, paclitaxel and bevacizumab fight the patient's cancer when given together;
-How much BAY 43-9006, carboplatin, paclitaxel and bevacizumab are in the patient's blood at specific times after they take the drugs.
Sorafenib, paclitaxel, carboplatin and bevacizumab have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of cancer, but have not been approved in the combination used in this study. Therefore, the use of this combination is investigational.
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Phase I/II Trial of Imatinib Mesylate (Gleevec; STI-571) in Treatment of Recurrent Oligodendroglioma and Mixed Oligoastrocytoma (N0272)
This research study is being done:

• To find out how well the investigational drug imatinib works on your brain tumor. Imatinib has been approved by the Food and Drug Administration to treat certain leukemias and a kind of digestive tumor called GIST (gastrointestinal stromal tumor).
• To find out what effects (good and bad) imatinib has on you and your tumor.
• To compare your response to imatinib with laboratory studies of your blood cells and tumor tissue that was taken in prior surgery. This part of the study is optional.

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Phase II Study Comparing Esomeprazole (Nexium)Versus Esomeprazole (Nexium) + Two Doses of Aspirin in Barrett's Esophagus Patients
This study is being done for these reasons:
- To learn about any effects (good and bad) esomeprazole (an acid blocker) with or without aspirin has on a patient and their esophagus;
- To find out if esomeprazole and aspirin have an effect on a patient's risk for getting cancer of the esophagus;
- There are no U.S. Food and Drug (FDA) approved drugs for the prevention of esophageal cancer.
Esomeprazole is a drug which has been approved by the FDA for the treatment of gastroesophageal reflux disease (GERD) and duodenal (small intestine) ulcers. Aspirin is a drug which is used for the treatment of joint inflammation
conditions, pain, fever, strokes, and heart disease. At the present time, neither of these agents is approved for the prevention of esophageal cancer.
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Phase II Study of Paced Breathing for Hot Flashes
Patients are being asked to take part in this research study because they have hot flashes and they
would like to have fewer and/or less severe hot flashes. Paced breathing is a kind of rhythmic and controlled breathing. Practicing paced breathing might be helpful in controlling the hot flashes participants experience.
This study is being done to:
- Look at what effects (good and bad) the paced breathing exercises will have on the patient and
their hot flashes.
- Look at what effects (good and bad) the paced breathing exercises will have on their mood, tiredness, sleep quality, and blood pressure.
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Phase II Study of the Histone Deacetylase Inhibitor PXD101 for the Treatment of Myelodysplastic Syndrome (MDS)
Patients are being asked to take part in this research study because they have Myelodysplastic Syndrome (MDS). This study is being done to learn what effects (good and bad) PXD101 has on a patient and their Myelodysplastic Syndrome. Early studies of PXD101 and other drugs like it suggest that PXD101 can correct the abnormal expression of genes in cancer cells. This study will test whether PXD101 can improve blood counts and reduce bone marrow abnormalities in patients with myelodysplastic syndrome. Also, progression to acute leukemia, survival, and toxicity will be monitored in patients on this study. PXD101 is an experimental agent not yet approved by the U.S. Food and Drug Administration (FDA).
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Phase III Study of Cyclophosphamide (Cytoxan) and Doxorubicin (Adriamycin) (CA) (4 Cycles) Versus Paclitaxel (Taxol) (4 Cycles) as Adjuvant Therapy for Breast Cancer in Women with 0-3 Positive Axillary Lymph Nodes
This study is being done to:
- Compare the effects (good and bad) of the standard chemotherapy, cyclophosphamide and doxorubicin (CA) with the chemotherapy drug, paclitaxel. These drugs are given after surgery, and this treatment is called adjuvant therapy.
- Compare the effects (good and bad) of eight weeks of treatment with 12 weeks of treatment using CA or paclitaxel.
CA treatment (given into a vein every two or three weeks for four treatments) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of breast cancer. Paclitaxel given after combination chemotherapy has been approved for the adjuvant treatment of breast cancer that has spread to the lymph nodes. Paclitaxel is also approved for the treatment of breast cancer that has grown or that has spread to other parts of the body after previous chemotherapy. The use of paclitaxel as an adjuvant treatment for breast cancer that has not spread to the lymph nodes as used in this study, are considered to be investigational or research.
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Quality of Life Study about Religious and Spiritual Activities Used as Coping Resources for Women with Advanced Ovarian, Primary Peritoneal, Fallopian Tube, or Early Stage Endometrial Cancer
More research is indicated to discover the true nature of the spiritual needs and concerns of women with newly diagnosed ovarian, primary peritoneal or fallopian tube cancer, or early stage endometrial cancer.
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Randomized Phase III Clinical Trial Comparing Outcomes of Immunologic Autograft Engineering Versus Standard Autograft Collection in Patients Undergoing Autologous Stem Cell Transplantation for Lymphoma
This study is being done to:
- Find out what effects (good and bad) the modification of the stem cell collection machine (apheresis machine) has on the collection of lymphocytes (the body immune cells that attack lymphoma).
- To see if collecting more lymphocytes by the new apheresis machine settings will or will not slow, decrease, or stop the growth of the patient's lymphoma.
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Risk-Based Treatment for Pediatric Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS)
Patients are being asked to take part in this study because they have a type of cancer called a non-rhabdomyosarcoma soft tissue sarcoma (NRSTS). Non-rhabdomyosarcoma soft tissue sarcomas are rare tumors and little is known about them. At the present time, doctors do not always know what the best treatment will be for a patient with one of these tumors. Studies done in both children and adults with NRSTS have shown that the amount of treatment a patient needs may be based on the risk group of the tumor.

Tumors are assigned a risk group based on features that influence how they behave. For NRSTS, the risk group is based on the type of cells in the tumor (the grade of the tumor), the size of the tumor, if the tumor has spread to other areas of the body, and how much of the tumor can be taken out by surgery. Patients with tumors in the low risk group may be cured with mild treatment, in some cases only surgery. Patients with tumors in the intermediate and high risk groups may need more treatment, including anti-cancer drugs (chemotherapy) and high energy X-ray therapy (radiation therapy).

It is common to enroll children and adolescents with cancer in a clinical trial that seeks to improve cancer treatment over time. Clinical trials include only people who choose to take part. Patients have a choice between a standard treatment for NRSTS and this clinical trial. Patients with NRSTS are commonly treated with surgery, radiation therapy and/or chemotherapy. The type(s) of treatment used depend on the type of tumor and the risk group.
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Selenium Supplementation in Persons With Resected Stage I Non-Small Cell Lung Cancer (E5597)
This research study is being done to determine the effectiveness of selenium in preventing the development of second primary lung tumors in patients who have undergone surgery to remove non-small cell lung cancer.
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SG040-0005, A Randomized, Phase IIb Placebo-controlled Study of RICE Chemotherapy (Rituximab, Ifosfamide, Carboplatin, and Etoposide) with and without SGN-40 (anti-CD40 humanized monoclonal antibody) for Second-line Treatment of Patients with Diffuse Large B-Cell Lymphoma (DLBCL)
Patients are being asked to take part in this research study to test whether a new drug called SGN-40, added to a commonly used drug combination of antibody (rituximab) and chemotherapy drugs (ifosfamide, carboplatin, and etoposide) called R-ICE, is safe and will improve the outcome for participants with diffuse large B-cell lymphoma (DLBCL) that has relapsed or failed to go away completely after initial treatment.
SGN-40 is a type of drug called a monoclonal antibody (the same type of drug as Rituxan or Mab Thera, which patients have previously received). Monoclonal antibodies are proteins that are designed to attack specific targets on cells. SGN-40 is an antibody which is made from human protein and reacts with a target, CD40, on white blood cells and tumor cells. CD40 is found on almost all DLBCL tumors.
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SPORE in Prostate Cancer
This research study is being done to collect regular and routine follow-up information related to the outcome of treatment for prostate cancer.

This study is also being done to relate treatment outcome to measurement of substances in the blood such as PSA and other markers. Also environmental and genetic factors that might be responsible for prostate cancer are being investigated.
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Study of Cancer Drugs Vatalanib (also called PTK/ZK) and Pemetrexed Disodium (also called ALIMTA) for People with Advanced Cancer.
This study is being done to:
- Learn the highest dose of the cancer drugs pemetrexed disodium (also called ALIMTA) and vatalanib (also called PTK/ZK) that can be given together without causing unacceptable bad side effects to patients with advanced cancer
- Learn about the side effects of pemetrexed disodium and PTK/ZK when given together
- Learn how the body handles or processes the drugs and other effects of the drugs in the body using blood and tissue samples.
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Systemic Administration of (Edmonston Strain) of Measles Virus, Genetically Engineered to Express NIS, with or without Cyclophosphamide in Patients with Recurrent or Refractory Multiple Myeloma (MC038C)
Researchers are trying to find new treatments that may be more effective at treating multiple myeloma. The "drug" used in this trial is a modified version of the measles virus used to vaccinate children. The virus has been altered by having an extra gene (piece of DNA) added for a protein called NIS inserted into it. NIS is normally found in the thyroid gland (a small gland in the neck) and helps the body concentrate iodine. Having this additional gene will make it possible to track where the virus goes in a patient's body.

Both the unmodified measles vaccination virus (MV-Edm) and this modified virus (MV-NIS) have been shown to multiply in and destroy myeloma cells in the test tube and in research mice. Researchers hope the MV-NIS will have the same effect in myeloma cells in patients. Because most people have either had the measles or had a measles vaccination, the patient's body may rapidly destroy the MV-NIS. This will be monitored by blood, urine, mouth rinsing, and imaging tests. It is for this reason, however, that some patients may receive in addition to the MV-NIS, a drug called cyclophosphamide. Cyclophosphamide is a common chemotherapy drug which also suppresses the immune system. If researchers find that patients rapidly destroy the MV-NIS, future patients will receive a low dose of cyclophosphamide before the MV-NIS injection to reduce the ability of the patient's immune system to quickly destroy the MV-NIS. Patients will be informed if they will be receiving MV-NIS alone or MV-NIS and the cyclophosphamide.

This virus has not been tested in humans before and it is not a vaccine.

This study is being done to:

-Test the safety of the administration through a vein (IV) of MV-NIS (with or without cyclophosphamide)
-Determine the maximum dose of the virus that can be safely administered in patients with myeloma (with and without cyclophosphamide)
-Determine the fate (where it is, how long it stays there, how it multiplies) of the virus in the body using I-123 with gamma camera imaging. These small doses of radioactive isotope (iodine-123) are used routinely to image the thyroid and other organs without any known problems
-Evaluate the effects of the virus on the body using blood, throat swabs, urine samples and bone marrow biopsies
-Evaluate whether this investigational virus can have any impact on the amount of disease present in patients
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The Use of a Heat Treatment and Vaccine for Patients with Stage 4 Melanoma
This study is being done to learn about the anti-tumor effectiveness of a heat shock vaccine in patients with stage 4 metastatic malignant melanoma.
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Transcutaneous (Topical) Peptide Immunization with NY-ESO-1b (SLLMWITQC) Peptide Using Resiquimod as an Immune Adjuvant: A Pilot Study
This study is being done to:
- Test the safety of the NY-ESO-1b/resiquimod vaccine
- See what effects (good and bad) the NY-ESO-1b/resiguimod vaccine has on a patient
- See if using the vaccine as a gel versus injection is more effective in stimulating the immune system

Both agents used in this study (NY-ESO-1b and resiquimod) have been approved by the U.S. Food and Drug Administration (FDA) for use in clinical trials. Neither has been approved for commercial use.
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Treatment of Children with Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD)
The standard treatment for Hodgkin disease is chemotherapy and radiation therapy (high-dose x-rays). Most patients are cured of their Hodgkin disease, but some people have late effects from the treatment later in life. Late effects can include problems with growth, organ function, and sometimes a second kind of cancer. Late effects may be caused by either chemotherapy or radiation. Researchers believe that if some people can be treated with less treatment or with surgery alone, then these people might have fewer late effects.
This study is being done to:
- See if "late effects" (side effects that show up later in life from the treatment) can be lowered or prevented by using less chemotherapy and radiation.
- Find out if using less chemotherapy and radiation to treat LPHD will still show high cure rates or if cure rates will be lower than with standard treatment.
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Treatment Study for Patients Diagnosed with High Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)
Leukemia is cancer of the blood. It starts in the bone marrow, which is the soft, spongy center of the long bones that makes the three major blood cells: white blood cells to fight infection; red blood cells that carry oxygen; and platelets that help blood clot and stop bleeding. Acute lymphoblastic leukemia (ALL) is a disease in which too many underdeveloped (not normal) infection-fighting white blood cells called "blasts", are found in the blood and bone marrow. These blasts crowd out the normal cells and can be found in the brain, spinal cord, and/or other organs of the body.

ALL is said to be "high risk" because patients have a white blood cell count of over 50,000 and/or they are ten years of age or older. Patients are also classified as "high risk' if any of the following applies:
- They are a male and have leukemia in their testes, regardless of their age and/or white blood cell count
- Patient has gotten treatment with steroid medicines, such as prednisone or decadron, in the month before they were diagnosed with leukemia

This study is being done to see if we can increase the cure rate of high risk ALL without increasing the side effects (unintended and unwanted results) of treatment.

The rate of survival keeps getting better for children and adolescents with high risk ALL. However, leukemia in the central nervous system (CNS) (brain and spinal cord) has become an increasing cause of treatment failure. This study will use an established chemotherapy regimen that has been very effective for treating children and adolescents with high risk ALL and will test if two different changes to this treatment can cure more patients.

Goal #1: To find out if using dexamethasone instead of prednisone during the first month of treatment can improve survival rates without causing more bad side effects. Prednisone and dexamethasone are closely related medicines called "steroids." In previous studies, steroids have been shown to be very effective against ALL, especially when given early in treatment. The standard treatment in high risk ALL is to give prednisone every day for 28 days during the first month of treatment.

When dexamethasone was used for all 28 days of the first month of treatment in many recent U.S. trials for children and adolescents with high risk ALL, there was a higher risk of infection. This included major life-threatening infections.

Because of this, the study will test two things:
- If 14 days of dexamethasone, instead of 28, can be taken without a higher number of bad side effects, and
- If 14 days of dexamethasone will be better than 28 days of prednisone in lowering the number of leukemia cells during the first month of treatment.

Goal#2: To find out if using high doses of methotrexate instead of using lower doses of
methotrexate on a schedule that gradually increases the dose, will keep the cancer from coming back without having more bad side effects.

Methotrexate is a cancer-fighting drug that is very important in the treatment of leukemia.
There are two different ways to give methotrexate during the interim maintenance stage of treatment. We know that both of these ways of giving methotrexate have been very effective in treating ALL, but they have never been directly compared to one another in children and adolescents with high risk ALL.

In"high dose" methotrexate treatment, the same dose of methotrexate is given a total of four times (every two weeks over a nine-week period).

In Capizzi methotrexate, methotrexate is given a total of five times (every 10 days over an eight-week period). Instead of being the same dose (as in high dose methotrexate treatment), Capizzi methotrexate is given at a lower dose the first time, and the amount of the dose slowly increases with each of the later doses. Capizzi methotrexate also includes treatment of another medicine, call PEG-asparaginase, which is given twice during this eight-week stage of treatment.

In addition to the goals related to the changes in treatment, there is an additional research
goal.
Goal#3: To see how quickly patients are helped by the induction phase (reach disease remission) and how well they do after treatment, as measured by the presence or absence of very small numbers of leukemia cells in the bone marrow after the first month of treatment.
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Treatment with Examestane, an Aromatase Inhibitor, versus Placebo, for Postmenopausal Women at High Risk for Developing Breast Cancer (MAP 3)
This research study is being done to test whether exemestane, an investigational drug, will decrease the number of people diagnosed with invasive breast cancer in women at high risk for developing breast cancer. Exemestane is an "investigational drug". The word "investigational" means that the drug has not been approved by the Food and Drug Administration (FDA) for this use in the United States or Canada.
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Treatment with Sorafenib (Nexavar) and CCI-779 (Temsirolimus) in Patients with Recurrent Glioblastoma
This study is being done:
-To find the highest dose of sorafenib that can be given without causing unacceptable bad side effects.
-To find out what effects (good and bad) sorafenib and CCI-779 have on a patient and the brain tumor.
-To compare patient's response to sorafenib and CCI-779 with laboratory studies of a patient's blood cells and tumor tissues.
-To look at sorafenib and CCI-779's ability to slow down the growth of the tumor.
A tumor has "switches" that turn on tumor cell growth and division. These two drugs are thought to prevent two of the main switch pathways in the tumor cells from working properly, which hopefully might prevent the cells from growing. Sorafenib and CCI-779 are experimental drugs not yet approved by the Food and Drug Administration.
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Trial of Intraperitoneal Administration of a CEA-Expressing Derivative Manufactured from a Genetically Engineered Strain of Measles Virus in Patients with Recurrent Ovarian Cancer (MC0117)
The purpose of this research study is:

• to learn the highest dose of a modified measles virus that can be given in the abdominal cavity of patients with recurrent ovarian cancer by using escalating doses of the virus in consecutive groups of patients without causing unacceptable side effects;
• to look at the side effects of the virus when administered in the abdominal cavity; and,
• to assess the virus' effects in the body using blood, urine, throat gargle specimen(s), and tissue samples.

The virus used in this study produces an active protein marker called CEA when it propagates. CEA is a protein, which is found in the blood of people with a variety of diseases, most notably cancer, and it has not been reported to cause disease. The longterm effects of inducing CEA in the blood are unknown. CEA can be measured in blood and used to follow the activity of the virus. MV-CEA is an investigational agent. It is not yet approved by the Food and Drug Administration (FDA) for treatment of cancer.
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Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients with Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma
This study is being done to:
- Find out the most effective treatment with the least amount of therapy that will still cure patients with low risk rhabdomyosarcoma

Results of past research studies with low-risk rhabdomyosarcoma patients show that using the three chemotherapy medicines (including cyclophosphamide) helps to cure more patients, but cyclophosphamide at the high doses that were used in these past studies can cause late effects.

The goals of this study are to see if:
1. Lower doses of cyclophosphamide used together with current standard doses of vincristine and dactinomycin can be as effective or better in curing patients as using the standard doses of vincristine and dactinomycin
2. The length of treatment can be shortened
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Z1031, A Phase 3 Trial Comparing 16 to 18 Weeks of Neoadjuvant (Given Before Surgery) Exemestane (25 mg daily), Letrozole (2.5 mg), or Anastrozole (1 mg) in Postmenopausal Women with Stage 2 and 3 Estrogen Receptor Positive Breast Cancer
Patients are being asked to take part in this study because they have a kind of breast cancer that is affected by the levels of hormones in their body. Patients are also postmenopausal, which can affect the way this kind of cancer responds to certain kinds of treatment. The surgical options do not include the kind of surgery known as breast conserving treatment (or lumpectomy), or in some cases, mastectomy, at this time.

Breast conserving treatment (lumpectomy) is a type of surgery in which the cancer, plus a small amount of surrounding normal tissue, is removed. Mastectomy is a surgical procedure in which the entire breast is removed. Researchers have been studying breast cancer to learn the best way to treat the disease. Chemotherapy (treatment with anticancer drugs) is commonly given before surgery to shrink breast tumors. The therapy in this research study consists of one of three drugs of a type called hormone therapy (a drug used to lower the level of the hormone estrogen). The hormone therapies being tested in this study are exemestane, anastrozole, and letrozole. Research has shown that reducing the amount of the hormone estrogen that gets to the cancer in postmenopausal women with hormone-dependent breast cancer can shrink the breast tumor before surgery.

This study is being done to find out whether it is better to receive exemestane, anastrozole, or letrozole to improve the chance that the breast cancer will get smaller before surgery.
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Zevalin Radionimmunotherapy with High-Dose Melphalan and Stem Cell Transplant for Multiple Myeloma (MC048A)
This research study is being done to:

• Test the safety of an antibody (a protein generated by immune system) called rituximab and a radioactive antibody called Yttrium-90 Zevalin when they are given together with standard high-dose melphalan chemotherapy and stem cell transplant
• See what effects (good and bad) this combination therapy has on you and your multiple myeloma
• Learn what effect this treatment has on your blood B lymphocytes after transplant
• See what effects the radioactive antibody (Yttrium-90 Zevalin) has on your myeloma cells.

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