Introduction

This family protocol summary is about the Children's Oncology Group study ACNS0821. It tells who is eligible and gives basic information about the study. More details about the study are in the consent form and protocol. You can get these from your oncologist.

ACNS0821 is a Phase II clinical trial. A trial is another word for a study. This study (clinical trial) is a therapeutic clinical trial. That means it is done to learn about treatment -- its safety and how well it works. The purpose of a Phase II trial is to learn if a new treatment works in treating a type of cancer and how it affects the body.

In a Phase II trial, patients with a specific type of cancer receive a new treatment using a dose that was found to be safe in a Phase I trial. Patients are checked for side effects of the treatment and to see whether the cancer shrinks or goes away.

Phase II trials are offered to patients whose disease has not responded to other less experimental treatments or to patients whose disease doesn't have a standard treatment. Phase II trials may be offered to patients with the type of disease that responded well in Phase I trials.

ACNS0821 compares 2 treatments. These treatments are called study arms. Usually, one study arm is the standard or the best proven current treatment. The other study arm has some changes or additions. The new treatment is thought to be at least as good as the standard treatment. It is not known if the new treatment will be better than the standard treatment.

Each child is assigned to a study arm by a method called randomization. This is a process like flipping a coin that assures that each child has a fair and equal chance of being assigned to any of the study arms. This way, the study arms can be compared fairly.

In most clinical trials, we will not know which treatment is better until all of the children taking part in the trial have completed treatment and have been getting checked for several years. If one of the treatments is found to be better or safer than the others while the trial is still going on, the trial will be stopped. All children still in the trial will be given the treatment with the best results when possible.

It is important to understand that participating in a clinical trial is entirely voluntary. The decision about whether or not to participate will not affect the care provided by the health care team in any way. You can find additional information about participation in clinical trials at www.childrensoncologygroup.org Always discuss any questions that you may have with your health care team.

Study Number

ACNS0821

Official Title

Temozolomide with Irinotecan versus Temozolomide, Irinotecan plus Bevacizumab for Recurrent/Refractory Medulloblastoma/CNS PNET of Childhood, A COG Randomized Phase II Screening Trial

Trial Opening Date

ACNS0821 opened on 11/22/2010. The study committee hopes to enroll 120 patients, which should take about 4-5 years.

General Patient Eligibility

• Age: <22 years
• Diagnosis: Medulloblastoma/CNS PNET that has returned after treatment (recurrent) or has not responded to treatment (refractory)

Please consult your doctor to determine whether your child may participate in this study.

General Background and Study Goal

There is currently no standard treatment for medulloblastoma that has come back after treatment (called "recurrent") or has not gone away with initial treatment (called "refractory").

Irinotecan and temozolomide are chemotherapy drugs that have been used to treat other types of cancer, and may be useful to treat recurrent or refractory medulloblastoma/CNS PNET. Bevacizumab is a medication that blocks the growth of blood vessels, including blood vessels in tumors. This medication may be helpful in treating medulloblastoma/CNS PNET. The goals of this study are to:

• study the effects of giving temozolomide and irinotecan to children/adolescents with recurrent or refractory medulloblastoma
• study the effects of adding bevacizumab to treatment with temozolomide and irinotecan for children/adolescents with recurrent or refractory medulloblastoma/CNS PNET.

Summary of Treatment

Patients will be randomized to one of two study arms:

• Arm A: temozolomide with irinotecan
• Arm B: temozolomide with irinotecan and bevacizumab

Each cycle of therapy lasts 28 days. All patients will receive temozolomide tablets or liquid once a day for 5 days and irinotecan through an IV once a day for 5 days. Patients on Arm B will receive an additional drug, bevacizumab, by IV, on Day 1 and Day 15 of each treatment cycle. Your oncologist will order scans to evaluate how the therapy is working. The therapy may continue for up to 12 cycles.

Special Considerations

Patients on Arm B may require an additional clinic visit on Day 15 for IV bevacizumab.

Risks and Side Effects

Chemotherapy can cause side effects during and after treatment. All risks and side effects will be explained in detail by your healthcare team during the consent process. They can answer any questions that you may have about giving permission for your child to be in the clinical trial or other aspects of care. Please refer to the consent form for a detailed explanation of the side effects associated with the treatment on this study.

Contact Information

Your child's oncologist and nurses are the best source for further information.

Study Chair:
Adam Levy M.D.
Montefiore Medical Center

FAMILY PROTOCOL SUMMARY REVIEW/APPROVALS