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ACNS0334 A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children< 36 Months Old

Purpose of study:

The purpose of this study is to compare two experimental treatment regimens to see if one is better for subjects 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. We would like to know if adding methotrexate will prove more effective than not adding methotrexate during induction therapy. We do not know if adding methotrexate will prove more effective and it may cause additional side effects.

The overall goal of this study is to compare the effects, good and/or bad of induction therapy that includes methotrexate with induction therapy that does not include methotrexate on infants with high-risk medulloblastoma/PNET to find out which is better.In this study, you will get either induction with methotrexate or induction without methotrexate. You will not get both.

Other goals of this study are:

  • To see how the study treatments affect the quality of life of subjects (people participating in the study)
  • To see how the study treatments affect the brain development of subjects
  • To look at tumor tissue to see if there are differences in tumors that can help scientists learn more about high-risk medulloblastoma/PNET and ways to treat it.?

Who can participate:

Children less than 36 months (3 years) of age at time of definitive surgery who have high risk Medulloblastoma will be eligible for study entry.

Additional screening for eligibility will be required.

What will happen during the study:

Randomization

Subjects (people participating in the study) will receive 1 of 2 different treatment plans. The treatment plans are called Regimen A and Regimen B. The treatment plan you receive is decided by a process called randomization. Randomization means that the treatment is assigned based on chance. It is a lot like flipping a coin, except that it is done by computer to make sure that there are about the same number of people on each treatment plan of the study. The randomization process is described in the COG Family Handbook for Children with Cancer.

Some subjects will be randomized to receive Regimen A induction; others will get Regimen B induction. The rest of the study treatment (surgery and consolidation with stem cell rescue) will be the same in both groups of subjects.

Treatment Plan

The treatment on this clinical trial takes about 6 months. It is divided into 3 stages: induction and consolidation with stem cell rescue. Subjects may also have a second surgery between induction and consolidation. Subjects will receive a total of 6 cycles of chemotherapy – 3 cycles during induction therapy and 3 cycles during consolidation therapy. Each cycle of Induction chemotherapy lasts about 21 days and Consolidation chemotherapy about 28 days.

Chemotherapy during Consolidation is given in three 28 day cycles. Your stem cells will be given after each cycle to help the bone marrow recover more quickly.

The 2 different treatment plans are the same except for the drugs given during induction.

Regimen A

You will get 3 cycles of induction therapy with common chemotherapy drugs. During this time, your blood stem cells will be collected and stored for use later in your therapy.

If the tumor goes away with the induction therapy, you will then have 3 cycles of consolidation therapy with 2 other drugs. With each cycle of consolidation when the drugs are done, some of your blood stem cells will be given back to you. This is called stem cell rescue.

If the tumor has gotten smaller but is not completely gone or does not change in size after induction therapy, you may have a second surgery to try to remove the rest of the tumor. After surgery, you will then have 3 cycles of consolidation therapy . With each cycle of consolidation when the drugs are done, some of your blood stem cells will be given back to you (stem cell rescue).

Regimen B
You will have 3 cycles of induction therapy with the same drugs used in Regimen A plus the addition of one other drug. The rest of the therapy is the same as on Regimen A.

Timing
Subjects will receive a total of 6 cycles of chemotherapy – 3 cycles during induction therapy and 3 cycles during consolidation therapy. Each cycle of Induction chemotherapy lasts about 21 days and Consolidation chemotherapy about 28 days.?

Who to contact:

PI: Mark Ranalli, MD
614-722-3563
Mark.Ranalli@nationwidechildrens.org
 

Nationwide Children's Hospital
700 Children's Drive Columbus, Ohio 43205 614.722.2000