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Purpose of study:
The overall goal of this study is to compare the effects, good and/or bad, of the chemotherapy drugs carboplatin and isotretinoin on subjects with high risk medulloblastoma and to find out if one or both are better than standard therapy alone.
In this study you will get either standard therapy alone, standard therapy plus one of the chemotherapy drugs added to the regimen, or standard therapy plus both of the chemotherapy drugs.
The main aims of this study are:
Other aims of this study are:
Who can participate:
What will happen during the study:
Subjects (people participating in the study) will receive 1 of 4 different treatment plans. The treatment plan they 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. Subjects who have had clinical depression or an allergy to parabens or soybeans will be randomized to Regimen A or Regimen B and will not receive isotretinoin.
The treatment plan will begin within 31 days after your surgery (to remove the tumor) and will involve a combination of radiation therapy and chemotherapy. The treatment on this clinical trial takes either 9 or 15 months (depending on the treatment arm you are randomized to) and is divided into 2 or 3 stages (also depending on the treatment arm you are randomized to).
The first stage of therapy is called chemoradiotherapy. All subjects will receive a combination of radiation therapy and chemotherapy to kill the cancer cells left over after surgery. This stage of therapy will take 6 weeks. Some subjects will have an extra chemotherapy drug, carboplatin, added to this treatment phase.
In the second stage of therapy, called Maintenance, all subjects will receive a combination of chemotherapy drugs (see Attachment #1 for a list of drugs used). Maintenance therapy will last 6 months. The goal of maintenance therapy is to kill any remaining cancer cells that are left over from chemoradiotherapy. Some subjects will have an extra chemotherapy drug, isotretinoin, added to their regimen of chemotherapy drugs during this stage.
Only some subjects will go onto a third stage of therapy, called Continuation. Continuation therapy will consist of 6 more months of therapy with the drug isotretinoin.
The stages of therapy and chemotherapy drugs that you receive will depend upon which treatment arm you are assigned to. You will be "randomized" into one of the study groups described below.
All subjects will receive the standard therapy for medulloblastoma, but some subjects will receive additional drugs during their course of therapy.
The four treatment arms are as follows:
Who to contact:
PI: Mark Ranalli, MD