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 2b Study of Molecular Responses to Imatinib (Gleevec) at Standard or Increased Doses, or Dasatinib (BMS-354825) (NSC-732517) for Previously Untreated Patients with Chronic Myelogenous Leukemia (CML) in Chronic Phase
This study is being done to:
- Find out what effects (good and bad) regular or increased doses of imatinib or
dasatinib has on a patient and their Chronic Myelogenous Leukemia (CML)
- Find out if giving a larger dose of imatinib will have any effect on the patient and their
CML or if giving the drug, dasatinib, will have any effect on the patient and their
CML.
- Find out which treatment works the best for CML in chronic phase when comparing
imatinib treatment at standard doses with higher doses of imatinib treatment and
with dasatinib treatment.
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A Phase 3 Study of Clofarabine and Cytarabine (ara-C) for Older Patients With Relapsed or Refractory (Resistant) Acute Myelogenous Leukemia (AML)
This study is being done to find out what effects (good and bad) clofarabine (also called Clolar) has on a patient and their acute myelogenous leaukemia (AML). Clofarabine is currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) who have not responded or have relapsed after receiving two prior treatments. Early clinical studies using clofarabine in adult patients with AML were conducted. However, clofarabine is not approved by the FDA for the treatment of AML; it is still investigational in this disease. Cytarabine (also called ara-C) is an FDA approved chemotherapy that is given as a treatment for AML.
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A Phase I Clinical Trial of Hyperbaric Oxygen Combined with Radiation and Chemotherapy for Locally Advanced Squamous Cell Cancer of the Head and Neck
Recently, it has become recognized as general knowledge that cancer cells are hypoxic (have a low oxygen concentration). Because of the low oxygen concentrations, many cancer treatments have not been successful. The idea behind this study is to give oxygen to patients by way of a hyperbaric chamber prior to chemotherapy and radiation in hopes of generating greater results in killing cancer cells. A hyperbaric chamber is a hard-shelled pressurized chamber that allows for the delivery of oxygen in higher concentrations.

The purpose of this study is to see how well patients tolerate the treatment and to determine if the treatment schedule is able to be done from a practical standpoint.
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A Phase I Study of Temozolomide (Temodar), Oral Irinotecan (CPT-11, Camptosar), and Vincristine for Children with Refractory (Resistant) Solid Tumors (Cancer)
This study is being done to:
- Find the highest safe dose of irinotecan that can be given together with temozolomide and vincristine, without causing bad side effects;
- Learn what kind of side effects (good or bad) temozolomide, irinotecan and vincristine can cause when given together;
- Learn more about the pharmacology of (how a patient's body handles the drug) temozolomide, irinotecan and vincristine;
- Find out if there is a genetic basis for how patients respond to this treatment in tests called pharmacogenetics or biology studies; and
- See if temozolomide, irinotecan and vincristine when given together is a helpful treatment for patient's tumor.

The drugs in this study are considered investigational because they have not been approved by the U.S. Food and Drug Administration (FDA) to be used together. All of the drugs used in this study have been approved by the FDA for use in adults with certain cancer types. Each drug has been given by itself to children before. Temozolomide and irinotecan has been given to children in another clinical trial. This is the first study in which all three of the drugs will be given to children together. The researchers are using these drugs because they seem to work together against cancer in test tubes and animals. The research staff do not know when used together if temozolomide, irinotecan and vincristine will work in people. There is a lot the researchers do not know about these drugs when used together.
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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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A Phase II Study of Sunitinib Malate (Sutent) for Treatment of Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Patients are being asked to take part in this research study because they have lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Sunitinib is an investigational anti-cancer agent that has not yet been approved by the U.S. Food and Drug Administration for use in CLL and SLL. This medication blocks a signaling pathway in tumor cells called the "VEGF pathway." In the laboratory, this pathway has been shown to be abnormal in CLL B-cells and to be used by these leukemia cells to prolong their survival. It is hoped that blocking this signaling pathway will lead to the death of CLL cells and improvement in the patient's condition.
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CNTO 328, A Phase 2 Multicenter Study of CNTO 328 (Anti IL- 6 Monoclonal Antibody) in Patients with Relapsed or Refractory (resistant) Multiple Myeloma
Patients are being asked to take part in this research study because the research staff want to find out what effects (good and bad) the CNTO 328 has on the patient and their multiple myeloma. CNTO 328 is a chimeric (murine-human) IgG1 kappa monoclonal antibody against IL-6. IL-6 is a central growth factor for myeloma cells. IL-6 is known to enhance cell growth (proliferation), differentiation, and survival of malignant plasma cells in multiple myeloma. The researchers hope that CNTO 328 will result in inhibition (inability of the cells to grow) of myeloma cell growth and apoptosis (cell death) of myeloma cells resulting in a clinical response (decrease in the level of M-protein). The researchers hope that this treatment option will have less side effects (be less toxic) and utilize the beneficial effects of an anti-IL-6 mAb in combination with dexamethasone for patients with advanced multiple myeloma.
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Effects of Urea/Lactic Acid-based Cream and/or Vitamin B6 to Help Prevent Skin Changes and/or Pain that may Result from Treatment with Capecitabine (Xeloda) in Patients with Cancer.
This study is being done to find out what effects (good and bad) urea/lactic acid-based cream and/or vitamin B6 has on patients, and see if it will help prevent the skin changes and/or pain that may result from treatment with capecitabine (Xeloda) for cancer. Patients are being asked to take part in this research study because they have cancer and are going to be treated with capecitabine (Xeloda) for the first time ever.
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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 3 Study to Evaluate Adjuvant cG250 Treatment vs. Placebo in Patients with Clear Cell Renal Cell Cancer and at High Risk for Recurrence
This study is being done to learn the effectiveness and safety of the investigational drug, cG250, to prevent or delay tumor recurrence when compared to a placebo (an inactive substance that looks the same as the study drug).

The study drug, cG250 is considered investigational because it is not approved by the U.S. Food and Drug Administration (FDA) for routine clinical use. The FDA has, however, approved the use of cG250 for this research study. cG250 has the potential to recognize and bind to cancer cells of the kidney. With this binding, the cancer cells are marked for destruction by a patient's immune system and a mechanism to destroy the cells can be activated.
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Phase 3 Trial Comparing Two Different Rituximab (Rituxan) Dosing Regimens for Patients with Indolent Non-Hodgkin Lymphoma
After treatment with standard dose rituximab, this study is being done to see if single doses of rituximab given at 12-week time periods can control the disease longer compared to giving rituximab once a week for four weeks in a row at time of disease progression.

This research study includes a laboratory study that will mathematically relate the rituximab levels in a patient's blood to their response to rituximab. Patients do not have to be in the laboratory study to take part in the treatment study.
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Phase 3 Vaccine Study of Proteinase 3 PR1 Peptide Mixed with Montanide ISA-51 VG Adjuvant and Administered with GM-CSF in Elderly Patients with Acute Myelogenous Leukemia (AML) in First Complete Remission or Adults in Second Complete Remission: A Pivotal Study
Patients are being asked to take part in this research study because they have Acute Myelogenous Leukemia (AML) that is in complete remission. The goal of this research study is to see if a new vaccine (called PR1) can prolong the duration of their complete remission from AML and help patients live longer.


The PR1 vaccine consists of two components. The vaccine includes part of a protein that is made by the leukemia cells. This protein fragment is called a peptide. Another component of the vaccine is an oil-based liquid to help the body respond to the vaccine. The liquid is called an adjuvant. The name of the specific adjuvant in this study is Montanide ISA-51 VG. The vaccine may help fight leukemia by making a patient's normal white blood cells kill the leukemia cells. The vaccine is administered subcutaneously (under the skin, like an insulin shot) on a patient's thighs and arms.
Patients will also receive a drug called GM-CSF (granulocyte-macrophage colony stimulating factor) through a needle under the skin in the same area as the PR1 vaccine.
GM-CSF is a drug that makes blood cells grow and may also make the vaccine stronger.
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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 Gemcitabine (Gemzar) and Carboplatin With or Without AZD2171 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer
The study is being done to:

Compare the effects, good and/or bad, of using AZD2171 in combination with the standard chemotherapy drugs gemcitabine and carboplatin versus standard chemotherapy drugs alone, on the patient and their NSCLC to find out which is better.
Find out if there are individual differences and/or tumor characteristics that will affect response to treatment
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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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17-Allylaminogeldanamycin (17AAG) in Advanced Medullary and Differentiated Thyroid Cancers (MC0476)
This research study is being done to learn what effects (good and bad) 17AAG has on you and your advanced thyroid carcinoma.
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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).

A Phase 1 Study of ABT-888 in Combination with Temozolomide (TMZ, Temodar) in Patients with Non-Hematologic (Blood) Malignancies (Cancer) and Metastatic Melanoma (MM)
This study is being done to:
- Evaluate the safety and tolerability of ABT-888 in combination with TMZ in treating solid cancers and metastatic melanoma
- Find the highest safe dose of ABT-888 in combination with TMZ (administered at one of two standard doses)
- Learn how the body handles and responds to treatment with ABT-888 and TMZ

Patients are also being asked to take part in an optional portion of the study to identify genetic reasons why certain individuals may respond differently to treatment with ABT-888 and TMZ.
ABT-888 is a new investigational drug being developed by Abbott Laboratories (Abbott) that interferes with the activity of PARP. PARP is an enzyme (protein) that may help cancer cells overcome injury or damage caused by radiation and certain types of chemotherapy. ABT-888 is not yet approved for use in the United States or any other countries. The U.S. Food and Drug
Administration (FDA) has allowed the use of ABT-888 in clinical trials.

TMZ is a chemotherapy drug that is approved by the FDA for the treatment of some types of brain cancer, and in Australia for the treatment of metastatic melanoma. However, the combination of ABT-888 and TMZ is also considered investigational. This clinical trial is the first study of this drug combination in humans.
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A Phase 1/2, Open-Label Study of the JAK2 Inhibitor INCB018424 Administered Orally to Patients with Primary Myelofibrosis (PMF) and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
Patients are being asked to take part in this research study because they have been diagnosed with primary myelofibrosis (PMF, normal bone marrow cells have been replaced by fibrous tissue) and post polycythemia vera/essential thrombocythemia myelofibrosis (Post-PV/ET MF, there are excessive red blood cells and/or excessive platelets). These are myeloproliferative disorders (MPDs).

The study will evaluate the safety, tolerability, side effects, levels of the drug in a patient's blood, and the maximum tolerated dose of the investigational drug (INCB018424). Investigational means that the drug being tested has not been approved by the United States Food and Drug Administration (FDA) as a prescription or over-the-counter medicine. Information from this study will be used to determine how well the study medication works and to have a better understanding of how the study medication works in people with a different genetic mutation (change), such as JAK2. Study of the structure of normal and abnormal chromosome (genetic) material and JAK2 mutation test
will be done during the course of the patient's participation in the study. These are genetic tests that will require a blood draw or bone marrow aspirates or biopsies.

Human cells contain genetic material that acts as an instruction book to direct cell
splitting and copying, to help form different body parts, and to determine our physical appearance. This genetic material (DNA and RNA) is organized in a code that produces
proteins that perform many bodily functions. Parts of the genetic code that code into specific proteins are called genes. Differences in the gene's code could mean a different eye color, different skin color, or in some cases differences in how people get certain diseases or why their bodies react differently to certain medications. Studying the difference in genes can lead to better understanding of diseases and body processes, and can help develop new medicines.

There will be 2 phases of the study. The purpose of the dose-escalation phase is to find out how safe it is, what the highest dosage of the drug is that can be tolerated, how the drug is absorbed and its action on the patient's body, the effectiveness and to determine a dose of INCB018424 for the expanded cohort phase of the study. The purpose of the expanded cohort is to enroll more patients to further assess the safety and usefulness of the study medication at one specific dose. Depending on the time of the patient's enrollment, they will participate in either the dose-escalation or expanded cohort phase of the study. Patients will be told which phase of the study they are in.
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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 Evaluation of Dose-Painted IMRT (Intensity Modulated Radiation Therapy) in Combination with 5-Fluorouracil (5FU) and Mitomycin-C for Cancer of the Anal Canal
Until recently, surgery that removed the anus and rectum was considered standard therapy for treating anal cancer. In this type of surgery, the bowel is attached to a permanent opening in the skin of the stomach (colostomy). Waste products from the bowel leave the body through this opening and are collected in a bag, which is changed when necessary.

Radiation therapy and chemotherapy (drugs that fight cancer) when given together have been shown to reduce the need for surgery while preserving the anus and rectum. Patients will only need surgery if radiation and chemotherapy do not get rid of the cancer or if it grows back at a later time.
Standard radiation therapy, although effective in killing cancer cells, has many side effects that may be unpleasant and sometimes may cause long-term complications. This is because the radiation can harm normal parts of the body while killing cancer tissue.

What is IMRT?
Standard radiation techniques cannot avoid delivering radiation to normal tissues (such as bone, bladder, bowel, genitalia, and skin) that are very close to the cancer and to places to which cancer can spread. Normal tissues do not need to get radiation. New ways of giving radiation such as IMRT (Intensity Modulated Radiation Therapy) spare some of these normal tissues and may reduce unwanted side effects. IMRT is an advanced radiation therapy delivery technique. IMRT tries to lower the amount of radiation that normal tissues receive, while still delivering the desired amount of radiation to the cancer and to the areas that the patient's doctor thinks may have cancer cells, such as lymph nodes. IMRT does this by using multiple computer-controlled radiation beams aimed at the patient's cancer, while still delivering a radiation dose comparable to standard radiation.

This research is being done to see if it is possible to reduce the amount of radiation given to the normal areas around anal cancers by using IMRT and to reduce the side effects that are seen with standard radiation methods. It is not known whether IMRT, which is being used to reduce side effects, will result in the control of cancer or the decreased need for surgery as is seen with standard radiation.
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A Phase 2 Study of Carfilzomib in Patients with Relapsed and Refractory (Resistant) 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 previously received bortezomib and either thalidomide or lenalidomide. 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 2 Study of E7389 (Halichondrin B Analog) to Treat Patients Diagnosed with Prostate Cancer which has spread (Metastatic) and is Resistant to Hormonal Therapy
The purpose of this study is to find out the effects, good and bad, E7389 (Halichondrin B analog) has on a patient and their prostate cancer. E7389 (Halichondrin B analog) is an investigational drug. It has not yet been approved by the U.S. Food and Drug Administration (FDA) for use in treating prostate cancer.
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A Phase 2 Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis +/- Chemotherapy for Post-operative Patients with either Endometrial or Cervical Cancer
Patients are being asked to take part in this research study because they have endometrial or cervical cancer that has a high risk for coming back as pelvic or endometrial cancer. The purpose of this study is to determine if an advanced radiation therapy delivery technique called intensity modulated radiation therapy (IMRT see definition below) can spare the patient's normal tissue, including small bowel and large bowel, from radiation.

Definition of IMRT: Many normal tissues, including small bowel and large bowel, are very close to areas at high risk of cancer coming back, such as lymph nodes and vagina. Standard radiation techniques cannot avoid delivering radiation to these normal tissues that do not need to get radiation. IMRT tries to lower the amount of radiation that normal tissues receive, while still delivering the desired amount of radiation to the cancer and to areas that the study doctor thinks may have cancer cells, such as lymph nodes in the pelvis. IMRT does this by using multiple, complicated computer-controlled radiation beams aimed at a patient's cancer.
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A Phase 2 Study of Irinotecan + Temozolomide (Temodar) in Children with Recurrent Neuroblastoma
In the past, children with neuroblastoma that has not responded to previous therapy or neuroblastoma that has come back after therapy has ended have not responded to chemotherapy very well. This study is being done to find out whether neuroblastoma in children who have recurrent or refractory (resistant) disease responds to treatment when the children are given the chemotherapy drugs irinotecan and temozolomide. It is also being done to find out what effects good and bad irinotecan and temozolomide have on the patient and their neuroblastoma. The drugs irinotecan and temozolomide can be given to patients who are not enrolled on this study. The experimental parts of this treatment are the drug doses and the schedule with which they are given.
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A Phase 2 Study of LY573636 Administered as an Intravenous Infusion on Day 1 of a 21-Day Cycle as Second-Line Treatment in Patients with Unresectable or Metastatic Melanoma
This study is being done to find out if the study drug can help patients with this disease and to find out what effects (good and bad) the study drug has on the patient. The study drug, LY 573636 is investigational and not approved for use by the U.S. Food and Drug Administration (FDA).
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A Phase 2 Study of SGN-40 (anti-huCD40 monoclonal antibody) in Patients with Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)
This study is being done to find out what effects (good and bad) SGN-40 has on a patient and large B-cell lymphoma tumors. SGN-40 is an investigational drug, which means it has not been approved for use by the U.S. Food and Drug Administration (FDA). SGN-40 is a monoclonal antibody drug. An antibody is a type of protein that helps protect the body against foreign materials such as bacteria (germs) and viruses. 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 which reacts with the target, CD40, on white blood cells and tumor cells.
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A Phase 2 Study of Sulindac (Clinoril) and Tamoxifen in Patients with Desmoid Tumors that are Recurrent or Not Amenable (Not Responding) to Standard Therapy
This study is being done to:
- Find the effects (good and bad) when combining sulindac and tamoxifen
- Find out if sulindac and tamoxifen are helpful in treating desmoid tumors
- Study tumor samples in a laboratory and find out if there is a way to tell if tumor cells will respond to treatment with sulindac and tamoxifen

Patients are being asked to take part in this study because they have a rare soft tissue tumor called a desmoid tumor (desmoid tumors are also called fibromatosis or aggressive fibromatosis). Surgery and/or radiation therapy are the standard treatment for these tumors, but sometimes, because of the location or size of the tumor, it is not possible to do surgery and/or radiation therapy. In other cases, these treatments are done and the tumor comes back (this is called recurrent tumor). Patients are being asked to take part in this study because their tumor cannot be treated with surgery and/or radiation, or because the tumor has come back.

Sulindac is a drug approved to treat inflammation in patients with arthritis. Several published reports suggest that sulindac may have anti-tumor activity in adults with desmoid tumor. Tamoxifen is an estrogen-blocking drug approved for the treatment of breast cancer. Researchers have reported that tamoxifen may have anti-tumor activity against desmoid tumors. Sulindac and tamoxifen have been investigated, separately and together, in recent clinical studies of adults and children with different types of tumor, including desmoid tumor. Pediatric researchers would like to find out if this combination of sulindac and tamoxifen, taken by mouth, can be taken by children and if this combination has anti-tumor activity against desmoid tumor in children whose tumor cannot be treated with surgery or radiation therapy or whose desmoid tumor has come back.
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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 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 Clinical Trial of the Efficacy and Safety of Subsequent Treatment with the Zevalin (ibritumomab tiuxetan) Study Regimen Versus Observation in Patients with Diffuse Large B-Cell Lymphoma Who are in Complete Remission After First-Line CHOP-Rituximab (CHOP-R) Therapy
This study is being done to find out what effects (good and bad) the drug regimen Zevalin has on a patient and their cancer. Zevalin has been approved by the U.S. Food and Drug Administration (FDA) for one type of lymphoma. This study is being performed to see if the treatment can also be used safely and effectively in patients with a different type of lymphoma known as diffuse large B-cell lymphoma (DLBCL). The use of Zevalin for the treatment of DLBCL is experimental.



The Zevalin regimen includes treatment with two different monoclonal antibodies: rituximab (Rituxan) and ibritumomab tiuxetan (Zevalin). An antibody is a type of protein found in the blood that helps protect the body against foreign matter such as bacteria and viruses. A monoclonal antibody is an antibody produced in the laboratory that attaches to specific kinds of cells. The Zevalin antibodies attach specifically to lymphoma cells. Antibodies can be administered alone, as with rituximab. Or, as with ibritumomab tiuxetan, they can carry small particles of radiation, allowing them to kill several cancer cells at one time.
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A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Treatment with 2 mg Intralesional Allovectin-7 Compared to Dacarbazine (DTIC) or Temozolomide (TMZ, Temodar) in Patients with Recurrent Metastatic Melanoma
The purpose of this study is to evaluate how safe Allovectin-7 is, and how well Allovectin-7 works as a possible treatment for melanoma in comparison to the chemotherapies dacarbazine (DTIC) or temozolomide (TMZ). This study will take place at multiple sites across the country and will enroll approximately 375 patients with metastatic melanoma (cancer that has spread). The treatment patients receive will consist of the injection of Allovectin-7 directly into their tumor or either DTIC chemotherapy given through their veins or TMZ capsules taken by mouth.
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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 for the Treatment of Children and Adolescents with Newly Diagnosed Low Risk Hodgkin Disease
Patients are being asked to take part in this study because they have a type of cancer called Hodgkin disease, a type of lymphoma (cancer of the lymph system). The lymph system is made up of tissue throughout the body that makes and stores infection-fighting cells. Hodgkin disease is one of the most treatable and curable childhood cancers. The standard treatment for Hodgkin disease involves chemotherapy (treatment with anti-cancer drugs) and radiation therapy (the use of high-dose x-rays to kill cancer cells).

Although patients are cured from their cancer, some experience bad effects from treatment later in life. These kinds of side effects are often referred to as "late effects."
This can include problems with growth, problems with some organ functions, and sometimes another cancer develops. It is thought that if some patients can be successfully treated with less intense therapy, those patients might have less bad effects later in life.
In this study, patients whose disease goes away after initial treatment with three cycles of chemotherapy (anti-cancer drugs) will be done with treatment. They will not have any radiation. Treatment without radiation therapy is considered the experimental treatment on this study. Patients whose disease does not go away after initial treatment with three cycles of chemotherapy will have radiation therapy.

If patients only have chemotherapy on this study, and their disease is suspected to have returned, then the study doctors will arrange for a biopsy in order to determine whether or
not their disease has returned. If their disease returns after going away (this is called a relapse) the study doctors will look at how widespread the relapse is, and certain other
symptoms, in order to find out if a patient has a low-risk or a high-risk relapse. Low risk
means their disease has only returned in a few lymph nodes and they have no symptoms like fever, drenching night sweats and/or weight loss. High risk means their disease is in many places and they have symptoms like fever, drenching night sweats and/or weight loss. If a patient has a high-risk relapse, they will be taken off all study therapy and their study doctor will talk to the patient about other treatment options. If they have a low-risk relapse, the research staff will ask the patient to take part in the second part of this study. If patients agree to take part, they will be given additional chemotherapy and radiation. The relapse treatment they will get will be less intensive than the standard relapse treatment and is also considered experimental treatment.
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A Phase 3 Study of Docetaxel (Taxotere) in Combination with CG1940 and CG8711 versus Docetaxel and Prednisone in Taxane-Naive Patients with Metastatic Hormone-Refractory Prostate Cancer with Pain
This study is being done to:
- Study the effects (good and bad) of docetaxel in combination with CG1940/CG8711 versus docetaxel and Prednisone will have on a patient, their pain level, and their metastatic prostate cancer
- Compare the effectiveness of docetaxel in combination with CG1940/CG8711 versus docetaxel and prednisone alone

CG1940 and CG8711 are two parts of an investigational product that is made from prostate cancer cells. The prostate cancer cells used to make this CG1940/CG8711 have been changed so that they release something called GM-CSF (granulocyte-macrophage
colony-stimulating factor) to help make the immune system work against cancer. GMCSF is something made by a patient's body that increases the amount of certain white blood cells and makes them more active.
To make the CG1940/CG8711, the gene for GM-CSF was put into the prostate cancer cells using an artificial virus that has parts of a virus called Adeno-Associated Virus. The cells were then treated with radiation so they cannot grow or divide after they are injected under the skin. The cells themselves are not radioactive. Because a gene was put into the cells this is a form of gene therapy, which is experimental, and is not approved by the US Food and Drug Administration (FDA) unless patients are receiving it as part of a research study such as this one.

Docetaxel is an anti-cancer drug that has been approved by the FDA to treat different types of cancer including prostate cancer. Docetaxel is the common name for the commercial drug Taxotere. Prednisone is a type of drug called a steroid that is used in many different types of disease to reduce inflammation. It is used in prostate cancer treatment to ease symptoms such as pain.

Previous studies with CG1940/CG8711 alone have shown that it is generally well tolerated. In these studies it was observed that PSA (Prostate Specific Antigen) levels could continue to rise during the first few months of immunotherapy. It was also observed that for some patients the PSA level dropped or stabilized after it has initially risen. A possible explanation for this delayed drop in PSA is that it takes time for the body to develop an immune response against the cancer cells.
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A Phase 3 Study of Dose-intensive Response-based Chemotherapy and Radiation Therapy for Children and Adolescents with Newly Diagnosed Intermediate Risk Hodgkin Disease
- The standard treatment for Hodgkin's disease is chemotherapy and radiation. This study is being done to find out if more treatment for slow early responders (patients who do not respond well to the first three cycles of treatment on this study) is better or worse than the standard treatment for Hodgkin's disease.

This study is also being done to find out if:
- Patients who have an early complete response (patients who respond very well to the three cycles of treatment) can be treated successfully without radiation treatment
- Certain factors like symptoms, age, sex, and blood test results tell how well a patient will respond to treatment
- What effects (good and bad) chemotherapy or radiation therapy has on a patient and their Hodgkin disease
- PET scans can give useful information about which places in the body are affected by Hodgkin disease. This is a test that helps to see the activity of tumor in the body. It takes about three to four hours and involves injecting a small amount of radioactive compound and seeing how much of it collects within the areas of the Hodgkin disease. It may be easier and more accurate than the gallium scan test that is used now. Mayo patients will take part in this study of PET scans. The study doctor will tell the patient if they will get a PET scan, a gallium scan, or both.
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A Phase 3 Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) (Followed by Surgery for Selected Patients) for Stage 3 and 4 Head and Neck Cancer
The purpose of this study is to compare the effects, good and/or bad, of radiation therapy and chemotherapy (cisplatin) with radiation therapy, chemotherapy, and cetuximab (C225) on you and your advanced head and neck cancer to find out which is better. In this study, you will get radiation and cisplatin or radiation, cisplatin, and C225.

C225 was approved in 2004 as a treatment for patients with colorectal cancer, and when this study began, C225 was an experimental treatment for patients with head and neck cancer. In 2006, the FDA approved C225 for the treatment of head and neck cancer. C225 may delay or prevent tumor growth by blocking certain cellular chemical pathways that lead to tumor development.

In addition, some patients in this study will have a combination of PET (Positron Emission Tomography) and CT (Computed Tomography) scan (explained below). For those patients, this study will see if PET/CT is a good way to find out the effect of treatment on their cancer.
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A Phase 3 Trial of Treatment of Advanced-Stage Anaplastic Large Cell Lymphoma (ALCL) with Standard APO (Doxorubicin, Prednisone, Vincristine) versus Consolidation with a Regimen Including Vinblastine
This study is being done to:
- Determine the effects (good and bad) of changing from the standard drug vincristine to the drug vinblastine in treating anaplastic large-cell lymphoma (ALCL) and whether or not it will help more patients' disease to get better and stay better
- Gain more understanding of the biology of ALCL and how certain biological markers might relate to treatment outcome

Patients are being asked to take part in this study because they have ALCL, a cancer of the lymphatic tissue. Lymphatic tissue carries lymphocytes to all parts of the body.
Lymphocytes are a special type of white blood cell. The type of ALCL that patients in this study have is at an advanced stage that might not respond as well to treatment. A drug called vinblastine has been shown to achieve remission in patients with ALCL that relapses. Remission occurs when there is no longer any sign of the disease, but if the cancer comes back, then it is considered to have relapsed. In this study, researchers want to see if using Vinblastine in the first treatment of ALCL works better than the standard treatment, which uses a drug called vincristine.
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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 Dose Finding Pilot Study of Stereotactic Body Radiotherapy for the Treatment of Liver Metastasis
This study will be done to learn
- The correct dose of radiotherapy for patients with liver metastases. This is called the Maximum Tolerated Dose (MTD).
- The effects of SBRT (both good and bad) on the patient and their cancer.
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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 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 Trial of the mTOR Inhibitor RAD001 (Everolimus) in Combination with VEGF Receptor Tyrosine Kinase Inhibitor PTK787/ZK 222584 in Patients with Advanced Solid Tumors (Cancer)
This study is being done to learn:
- The highest dose of the cancer drugs called RAD001 and PTK787 that can be given safely without causing bad side effects to patients with advanced cancer. A higher dose level has shown severe side effects in about two out of six patients. If patients consent to this study, they will be receiving the next lower dose level that was tolerated by a previous group of patients;
- About the side effects of RAD001 and PTK787 that may possibly occur when given together, and
- How the body handles or processes the drugs and the other effects of the drugs in the body using blood and tissue samples.
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A Phase I, Open label, Multicenter, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetic Properties of the Orally Administered Negative Enantiomer of Gossypol (AT-101) in Patients with Advanced Malignancies
This study is being done to:
- Test the safety of AT-101 in patients with advanced cancer
- Find the highest dose of AT-101 that can be given without causing unacceptable bad side effects
- Determine what doses of AT-101 should be used in future studies
- Learn how long AT-101 remains in a patient's blood
- Learn what effects (good and bad) AT-101 has on the patient and their cancer

AT-101 is an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA) for standard clinical use.
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A Phase I/II Multi-Center, Open Label Trial of the Safety and Efficacy of R935788 in Patients With Relapsed/Refractory (Resistant) B-Cell Lymphoma
R935788 (for convenience, referred to as R788) is an investigational drug that is being developed for the treatment of B-cell lymphoma. When R788 is broken down in the body it is converted to R940406 (referred to as R406). An investigational drug is one that is not approved by the U.S. Food and Drug Administration (FDA) for use in the United States, but may be used in research studies such as this one.

B-cell lymphoma is a cancer of the white blood cells (also called lymphocytes) that grow abnormally and can grow in many parts of the body, including the lymph nodes, spleen, bone marrow, blood, or other organs.

The purpose of this research study is to see if R788 is safe and effective in controlling lymphoma cancer when it is taken at two different doses, either 200 milligrams (mg) twice a day or 250 mg twice a day. The study will be conducted at many sites and enroll up to 60 patients.
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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-Hodgkins 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 Aerosolized GM-CSF In Patients with First Pulmonary (Lung) Recurrence of Osteosarcoma
This study is being done to find out:
- The effects (good and bad) from inhaling GM-CSF
- What the best dose level is for inhaling GM-CSF.
- If inhaling GM-CSF can delay or prevent another recurrence of osteosarcoma by looking for evidence that inhaling GM-CSF activated the immune system.

The standard treatment for lung recurrences of osteosarcoma is surgery to remove the disease and, possibly, more chemotherapy. This study is being done to investigate a new treatment approach using a drug, GM-CSF, commonly used to help blood cells get better from the effects of chemotherapy. Studies have been done recently with about 40 patients (mostly adults) to see if GM-CSF stimulates the body's immune system to destroy cancer cells in the lung (the immune system is the part of a patient's body that recognizes and destroys cells that are not normal body cells). In the first studies, subjects (patients) received the GM-CSF by using a nebulizer (a nebulizer is a device that turns a drug into a mist that can be inhaled into the lung). Nebulizers are commonly used by people with asthma.
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A Phase II Study of CCI-779 (Temsirolimus, Torisel) in Combination with Rituximab (Rituxan) in Patients with Relapsed or Refractory (Resistent) Mantle Cell Lymphoma
This study is being done to see:
- If the experimental drug CCI-779 when given with rituximab can slow down or stop the growth of mantle cell non-Hodgkin's lymphoma (MCL)
- What effects (good and bad) the combination of the two drugs has on a patient and their MCL.
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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 Study of Motexafin-Gadolinium and Radiation Therapy for Brainstem Glioma of Childhood
Patients are being asked to take part in this research study because they have been diagnosed with a type of brain tumor called brainstem glioma. Brainstem glioma is a disease in which cancer cells form in the tissues of the brain that is connected to the spinal cord. 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 brainstem glioma and this clinical trial.

What is the current standard of treatment for this disease?
The standard treatment for brainstem tumors is radiation therapy. Radiation therapy is the careful use of high-energy radiation to treat cancer. Radiation therapy destroys the cancer cells ability to reproduce. Surgery is not possible because the tumor is located in an area of the brain that is difficult to safely remove. Damage to this part of the brain as a result of the surgery can cause a child to become mentally and/or physically disabled.

Standard Treatment and Procedures Common to all Patients with Brainstem
Glioma

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

-Magnetic Resonance Imaging (MRI)
MRI uses radio waves and a strong magnetic field rather than x-rays to provide clear and
detailed pictures of organs and tissues inside the body. An MRI of the brain is performed to measure the size of the tumor to see how the treatment is working.

Methods for Giving Drugs
IV Motexafin-Gadolinium on this study will be given using a needle or tubing inserted into a vein.

Standard Tests and Procedures
The following tests and procedures are part of regular cancer care and may be done even if they do 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 women able to become pregnant
- Scans to monitor the patient's response to treatment

Why is this study being done?
The research staff are asking patients to take part in a research study of an anti-cancer medicine called Motexafin-Gadolinium that will be used together with radiation therapy to treat brainstem gliomas.

The overall goals of this study are to:
- Find out how well Motexafin-Gadolinium treatment plus radiation therapy controls the growth of brainstem gliomas;
- Learn more about the effects, good or bad, of Motexafin-Gadolinium treatment plus radiation therapy on patients with brainstem gliomas

Radiation therapy cures less than one out of ten children. Giving chemotherapy after radiation has not improved the therapy. The researchers want to try an experimental combination of giving Motexafin-Gadolinium each day just before the radiation treatment to try to make the radiation therapy work better than it does when it is given alone.

This is a Phase II study of the experimental drug Motexafin-Gadolinium along with
radiation therapy. A Phase II study is done to find out how well the drug improves the
disease. A Phase I clinical trial has been completed. The highest dose without too many
side effects was found in that study. The research staff want to find out if combining Motexafin-Gadolinium with radiation therapy is a better treatment than radiation alone, and if children treated this way will be more likely to be cured.
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A Phase II Study of the Combination of Cyclophosphamide (Cytoxan), Prednisone and Rituximab (Rituxan) (CPR) in Children, Adolescents and Young Adults with CD20 Positive Post-Transplant Lymphoproliferative Disease (PTLD) following Solid Organ Transplantation (SOT)
Patients are being asked to take part in this research study because they have post-transplant lymphoproliferative disease (PTLD) after their solid organ transplant (SOT). Since transplanted tissue is foreign to the body, the body can reject the transplanted tissue. To prevent rejection, patients are given anti-rejection drugs (also called immunosuppressive drugs). PTLD is a complication of the immunosuppressive drugs. It is caused when white blood cells divide and reproduce abnormally, the same way cancer cells grow out of control. PTLD acts the most like lymphoma or cancer of the lymph system (which makes and stores infection fighting white blood cells).


The usual first treatment for PTLD is to reduce or stop using the immunosuppression drugs. But some patients do not respond to this intervention (known as refractory PTLD).
In this study, patients will be treated with standard anti-cancer therapy, cyclophosphamide and prednisone, and a drug called rituximab (which research has shown may improve the outcome of lymphoma patients when it is added to standard chemotherapy). The goal of this study is to improve the outcome of refractory PTLD without increasing treatment-related side effects.


Why Is This Study Being Done?
? To find out if rituximab, together with the commonly used cancer drugs, cyclophosphamide and prednisone, is effective in treating PTLD after a solid organ transplant;
? To find out what the effects, good and bad, are for this drug combination;
? To study the biologic and genetic features of PTLD, including looking at the genes to see if they can predict how patients will respond to treatment on this study; and
? To get a sense of how many patients less than 31 years old have PTLD after a solid organ transplant.
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A Phase II Study of Trastuzumab-MCCDM1 Administered Intravenously (IV) to Patients with HER2-Positive Metastatic Breast Cancer Who Have Progressed While Receiving Trastuzumab (Herceptin).
The purpose of this study is to investigate an experimental drug called trastuzumab-
MCC-DM1 (T-DM1) for the treatment of metastatic breast cancer. T-DM1 is an experimental drug, which means it has not been approved by the United States Food and Drug Administration (FDA). This study is being done to learn whether T-DM1 can be given to humans safely and if it can slow or stop further tumor growth or make tumors get smaller in patients with metastatic breast cancer.
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A Phase II Study to Assess the Ability of Neoadjuvant Chemotherapy +/- Second Look Surgery to Eliminate All Measurable Disease Prior to Radiation for Non-Germinomatous Germ Cell Tumor (NGGCT)
This study is being done to:
- See if patients with non-germinomatous germ cell tumor (NGGCT) respond to the anti-cancer drugs (chemotherapy) used in the first part of this study, called Induction. These drugs are carboplatin, etoposide (VP-16), and ifosfamide.
- See if high-dose anti-cancer drugs (thiotepa plus VP-16) with peripheral blood stem cell (PBSC) rescue work better at getting rid of the cancer in patients who did not respond well enough to the standard-dose chemotherapy given in Induction
- Learn the survival rates of patients with NGGCT who get the treatment given by this study
- Learn the frequency of certain side effects that happen as a result of the treatment
- Watch how tumor markers in blood and spinal fluid correspond with results from scans, exams, or surgery in response to the chemotherapy treatment.

Patients are being asked to take part in this study because they have a type of brain cancer called NGGCT. This is a brain tumor formed by cancerous cells. Germ cells are very primitive cells. Germ cell tumors that arise in the brain account for less than 5 percent of all brain tumors.
There are different types of germ cell tumors. Doctors decide which type a patient has based on the results of a biopsy (a surgical procedure that takes out a part of the tumor for testing) and/or tumor markers.
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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 Melanoma Peptide (protein) Vaccinations for Patients with Metastatic Melanoma.
This study is being done to:
- Find out what effects (good and bad) the melanoma peptide vaccines have on patients with melanoma. Melanoma peptide vaccines are solutions of short proteins similar to proteins found in melanoma tumor tissue. This vaccine is being tested to see if it can stimulate the immune system to react against these proteins and against cancer. These melanoma peptide vaccines are considered investigational anticancer treatments as they have not been approved by the Food and Drug Administration (FDA).
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A Phase II Trial of Sunitinib (SU11248) in Multiple Myeloma
Sunitinib is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration for use in treatment of multiple myeloma. In patients with this type of cancer there are increased numbers of blood vessels in a patient's bone marrow associated with the cancer cells. Sunitinib is known to be able to decrease the blood vessel formation in tumors and thus may be able to benefit patients. In addition, it is also known to decrease the effect of certain chemical substances secreted by the cancer cells that are known to be important for survival of the cancer cells. This is the reason we are studying the potential benefits of this drug.
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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 Study of Pilocarpine (Salogen) as Treatment for Vaginal Dryness in Post-Menopausal Women
This study is being done to see if pilocarpine will help with vaginal dryness. Pilocarpine is a drug that has been used to treat dry eyes and dry mouth. Patients are being asked to take part in this research study because they are post-menopausal and are experiencing vaginal dryness, and they have a history of breast cancer or do not want to take vaginal estrogen for a fear of increased risk of breast cancer.
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A Phase III Trial Evaluating the Effectiveness and Safety of Bevacizumab (Avastin), a Biologic Response Modifier Drug, in Combination with Chemotherapy Treatment in Patients with Previously Treated Metastatic Breast Cancer (cancer that has spread) (RIBBON II).
This study is being done to see if bevacizumab*, when given in combination with a standard-of-care treatment is able to:
- Increase how long people live with metastatic breast cancer that has gotten worse
- Delay tumor growth in people with metastatic breast cancer that has gotten worse
- Shrink tumors in people with metastatic breast cancer, and that has gotten worse
- To find out what effects (good and bad) the bevacizumab (a drug) has on patients and their cancer.

* Bevacizumab has not been approved by the U. S. Food and Drug Administration (FDA) for the treatment of breast cancer.
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A Pilot Study to Determine the Toxicity of the Addition of Rituximab to the Induction and Consolidation Phases and the Addition of Rasburicase to the Reduction Phase in Children with Newly Diagnosed Advanced B-Cell Leukemia/Lymphoma Treated with LMB/FAB Therapy
This study is being done to:
- Find out the effects, good and bad, of adding two new drugs, rituximab and rasburicase, to the standard chemotherapy drugs
- Find out the effects, good and bad, of rasburicase when given to see if it can lower the uric acid levels (salts found in patient's bloodstream)
- Compare the amount of cancer cells in the body before, during and after treatment
- Find out if there are proteins or genetic information (genes patients inherit from their parents) in the tumor cells that can tell researchers the best way to treat children with B-cell leukemia/lymphoma.

Non-Hodgkin's lymphoma is a cancer of the lymph nodes (tissue throughout the body that filters disease germs from the blood). B-cell leukemia is cancer of the blood that develops in the bone marrow where blood cells are made. (ALL is a disease in which too many underdeveloped [not normal] infection-fighting white blood cells (blasts) crowd out the normal cells).

The first investigational drug, rituximab, is an anti-cancer drug that attaches to lymphoma cells and causes these cancer cells to die by stimulating the body's own immune system (the system that recognizes and attacks cells that are not normal body cells). Rituximab has been given safely along with standard chemotherapy to adult NHL patients.

However, rituximab has not yet been used in combination with standard chemotherapy to treat children.

The second drug given on this trial is called rasburicase. Rasburicase is a drug that lowers uric acid levels in the blood. Uric acid levels go up because of the death of the normal cells and tumor cells when the chemotherapy is given. Too much uric acid in the blood can cause the kidneys to fail. Researchers want to see if rasburicase can lower the uric acid levels, but they also need to find out what kind of side effects children may have when they take rasburicase. The standard drugs used to treat B-cell lymphoma are vincristine, prednisone and cyclophosphamide.
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A Pilot Study Utilizing Molecular Profiling of Patients' Tumors to Find Potential Targets and Select Treatments for Their Refractory (Resistant) Cancers
The purpose of this study is to determine if a patient's tumor has any targets (specific proteins) that may respond to a treatment that has been chosen using a method called molecular profiling. Molecular profiling is a way to analyze the patient's tumor looking at DNA, RNA (genes) and proteins to determine possible therapeutic targets specific for their tumor, and thus potentially enabling the selection of a more specific therapy for the patient's cancer.
After a molecular profiling is performed on the patient's tumor, by a specialty certified
laboratory (CLIA certified) called Molecular Profiling Institute (MPI) a specific
treatment will be selected by an oncology doctor. Using specific guidelines set in place
as part of the study, the Medical Monitor for this study will recommend a treatment
regimen based on the results of the molecular profiling to the patient's local doctor. Their local doctor will prescribe the appropriate treatment for the patient.
The therapy selected from the molecular profiling analysis (test) might be different than the treatment which is currently considered standard treatment of the patient's disease. There will be no investigational drugs used as part of this study. The doctor will treat the patient using drugs that are already approved by the U.S. Food and Drug Administration (FDA) and commercially available to treat cancer, although not necessarily the patient's specific type of cancer.
If the results of the molecular profiling analysis do not reveal any therapeutic targets, the patient will be treated with a therapy selected by their doctor. The current expectation is that there is a 70 percent chance of identifying a therapeutic target on the patient's tumor using molecular profiling.
In addition, the research staff will determine how long the patient's tumor stays stable or shrinks compared to how long their tumor stayed stable or shrank on the treatment the patient had just received before entry in this study.
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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 of Daunorubicin and Gemtuzumab-Ozogamicin Therapies to Treat Adult Acute Myeloid Leukemia (E1900)
This study is being done to find out which of the study treatments is best for patients with newly diagnosed AML.
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A Study of Methotrexate to Treat LGL Leukemia (E5998)
This study is being done to compare the effects of Methotrexate with prednisone and cyclophosphamide with prednisone. Study doctors want to find out whether the Methotrexate with prednisone decreases the number of large granular lymphocytic leukemia (LGL) cells in the blood and whether it helps to increase the number of red blood cells.
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A Study to Evaluate an Investigational Treatment Versus Placebo in Patients with Kidney Cancer and a High Risk of Recurrence
This research study is being done to learn the effectiveness and safety of an investigational drug to prevent or delay kidney tumor recurrence when compared to a placebo.
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A study to look at the dosing, safety and tolerability of a Monoclonal Antibody, CP-751,871 in patients with advanced solid tumors (A4021010)
This study is being done to learn the highest dose of the investigational drug called CP-751,871 that can be given without causing unacceptable side effects and to see what effects (good or bad) it has on you and your cancer.
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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