Brain Tumors

Clinical Trials

Below is a list of Brain Tumors 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 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 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 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/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 study using an alkylating agent (Temozolomide) combined with radiation therapy for treating low-grade gliomas (RTOG 0424)
This research study is being done to:

• Find out whether a drug called Temozolomide combined with radiation will control a tumor longer than radiation alone or radiation combined with other chemotherapy drugs used in previous clinical trials
• Find out what effects (good and bad) Temozolomide and radiation has on a low-grade glioma

ACNS0232, Radiotherapy Alone vs. Chemotherapy Followed by Responsebased Radiotherapy for Newly Diagnosed Primary CNS (Central Nervous System) Germinoma
Patients are being asked to take part in this study because they have a type of cancer called a germinoma germ cell tumor, which can be a rapidly growing tumor able of spreading to other parts of the brain and spinal cord. Normal germ cells are the body's reproductive cells which are usually found in reproductive organs. Germ cells typically give rise to egg cells in ovaries of females and sperm cells in the testicles of males.
There are different types of germ cell tumors. Doctors find out which type a person has
based on the results of a biopsy (a surgical procedure that removes a portion of the tumor for testing) and/or tumor markers. Tumor markers are chemical substances (such as
proteins) that are produced by tumor cells and released into the bodily fluids. Germ cell tumors can be malignant and can sometimes spread through the brain and spinal canal before symptoms appear. The amount of radiation treatment patient's get, and the chance of cure, will depend on whether the disease has spread at the time the patient's diagnosis is made.
Germinoma germ cell tumors that start in the brain are most often treated with large doses of radiotherapy (high energy x-rays) with excellent cure rates. However, there is concern about the late effects of such treatment. Late effects are problems that arise later in life after treatment is completed such as learning difficulties, lower amounts of hormones or other problems in performing daily activities, depending on what area of the brain is treated with radiation therapy.
One of the goals of this study is to find out if using chemotherapy (anti-cancer drugs) and lower amounts of radiation therapy give the same results (cure rate) while lowering the late effects of higher doses of radiation therapy.

This is a phase III study, where patients are randomly assigned to either standard therapy such as radiotherapy (Regimen A) or experimental therapy (Regimen B) where patients receive both chemotherapy and radiotherapy in order to determine which treatment is better and/or safer. When patients enroll on this study they will be randomized to one of the two treatment arms. Randomization means that the treatment will be decided by chance, as in flipping a coin. This is done with a computer program. The two treatment arms are:

- Regimen A (this is the standard treatment with high doses of radiation therapy)
- Regimen B (this is treatment with chemotherapy and lower doses of radiation
therapy)

Both types of treatments have been shown in other smaller studies to be effective in bringing about long term remission, or control of the CNS germinoma.

Why Is This Study Being Done?
This study is being done to find out:
? The study is being done to try to reduce the frequency and severity of late effects without reducing the likelihood of cure.
? If the level of a protein called human chorionic gonadotrophin (HCG) that the tumor can release into the blood or CSF (the cerebrospinal fluid that surrounds the brain and spinal cord) can be used to tell how well each regimen will work.
? If there is any difference in the chance of being cured or having the cancer come back if the tumor has already spread by the time of diagnosis.
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ACNS0334, A Phase III Study for the Treatment of Newly Diagnosed Supratentorial PNET (primitive neuroectodermal tumor) and High Risk Medulloblastoma in Children < 36 months Old with Intensive Induction Chemotherapy with Methotrexate Followed by Consolidation with Stem Cell Rescue vs. the Same Therapy Without Methotrexate
Study Rationale:
Parents/ Guardians are being asked to allow their child to take part in this study because their child is less than three years old and has a tumor called a high risk medulloblastoma or primitive neuroectodermal tumor (PNET). Left untreated, these tumors are always fatal.


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


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

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

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

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

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

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

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

Researchers are also going to do research tests on some of the tumor tissue taken out during surgery. These tests are being done to better understand things about the tumor cells such as the kinds of proteins in them and if they have any genetic differences. The research staff will also collect some blood for these research tests. About one teaspoon of blood will be taken before the child starts treatment. An attempt will be made to obtain this sample at the same time the child is having other routine blood tests.
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CCI-779 (Temsirolimus) and Temozolomide (Temodar) in Combination with Radiation Therapy in Patients with Glioblastoma Multiforme (GBM)
This study is being done to:
-Add CCI-779 to the standard treatment temozolomide (TMZ) and radiation (RT), which is hoped to make the standard treatment better. CCI-779 helps to stop signals that cause tumors to grow.
-Test the safety of the CCI-779 when given in combination with TMZ or in combination with TMZ and RT.
-Find the highest safe dose of CCI-779, an investigational agent, to give with RT and TMZ, which can safely be given without causing bad side effects.
-See what effects (good and bad) it has on the patient and the cancer.
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Chemotherapy (Carboplatin and Isotretinoin) and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor (PNET)
Patients are being asked to take part in this research study because they have been diagnosed with a type of cancer called medulloblastoma, a type of brain tumor. This study is for patients with high risk medulloblastoma. The term, risk, refers to the chance of the cancer coming back after treatment.
One or more of the following factors make the cancer more likely to return after treatment:
- The tumor is not at the very back of the brain
- Some of the tumor was not removed by surgery
- The cancer has spread to more than one site
It is common to enroll children and adolescents with cancer in a clinical trial that seeks to improve cancer treatment over time. Clinical trials include only people who choose to take part. Patients have a choice between a standard treatment for medulloblastoma and this clinical trial.
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Drug and Radiation Therapy for the Treatment of Glioblastoma Multiforme (N0177)
This research study is being done to determine the effectiveness of combining an investigational drug called erlotinib (OSI-774) and radiation therapy in treating patients who have glioblastoma multiforme, a special type of brain tumor.
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Measles Virus Derivative Producing CEA (MV-CEA) in Patients with Recurrent Glioblastoma Multiforme (GBM)
This research study is being done to:

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

Phase I/II Trial of Imatinib Mesylate (Gleevec; STI-571) in Treatment of Recurrent Oligodendroglioma and Mixed Oligoastrocytoma (N0272)
This research study is being done:

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

Treatment with Sorafenib (Nexavar) and CCI-779 (Temsirolimus) in Patients with Recurrent Glioblastoma
This study is being done:
-To find the highest dose of sorafenib that can be given without causing unacceptable bad side effects.
-To find out what effects (good and bad) sorafenib and CCI-779 have on a patient and the brain tumor.
-To compare patient's response to sorafenib and CCI-779 with laboratory studies of a patient's blood cells and tumor tissues.
-To look at sorafenib and CCI-779's ability to slow down the growth of the tumor.
A tumor has "switches" that turn on tumor cell growth and division. These two drugs are thought to prevent two of the main switch pathways in the tumor cells from working properly, which hopefully might prevent the cells from growing. Sorafenib and CCI-779 are experimental drugs not yet approved by the Food and Drug Administration.
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