Clinical Trial: Cancer, Brain Tumor

ACNS0332: Medulloblastoma/PNET study PRO00000577

Full Name

ACNS0332: Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients: A Groupwide Phase III Study

Description

Treatment on this study will begin within 31 days after the participant's surgery (to remove the tumor) and will involve a combination of radiation therapy and chemotherapy. Treatment on this study takes either 9 or 15 months depending on the arm to which the participant is assigned, and is divided into 2 or 3 stages. In the first stage (called chemoradiotherapy), all participants will receive a combination of radiation therapy and chemotherapy. This stage will last 6 weeks. In the second stage of therapy (called Maintenance), all participants will receive a combination of chemotherapy drugs. This stage will last for 6 months. The third stage is called Continuation, but not all participants go onto the third stage. The continuation stage will consist of 6 more months of therapy with the drug isotretinoin. The stages of therapy and chemotherapy the participant receives will depend upon which arm they are assigned. Those assigned to Arm A will receive standard chemoradiotherapy (radiation therapy and the drug vincristine). Those participants will then receive standard Maintenance chemotherapy. Those assigned to Arm B will receive chemoradiotherapy plus the experimental drug carboplatin. Those participants will then receive standard Maintenance chemotherapy. Those assigned to Arm C will receive standard chemoradiotherapy. They will then receive Maintenance therapy with the addition of the drug isotretinoin and Continuation therapy with isotretinoin. Those assigned to Arm D will receive chemoradiotherapy plus the experimental drug carboplatin. They will then receive Maintenance therapy with the addition of the drug isotretinoin and Continuation therapy with isotretinoin. Participants assigned to Arm C or D will be required to complete a "Patient Drug Diary". After completion of study treatment, patients are followed periodically for up to 10 years. A total of 300 patients will be accrued for this study.

Eligibility

Inclusion Criteria

o 3 to 21 Years
o Histologically confirmed diagnosis
o Meets required staging criteria
o Must be able to complete required testing, i.e MRI, etc.