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

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

1. To determine whether carboplatin radiosensitization increases long term event-free survival for high risk medulloblastoma/PNET patients.
2. To determine whether Isotretinoin increases long term event-free survival for high risk medulloblastoma/PNET patients.
3. To compare residual disease response to radiation alone versus radiation plus carboplatin.
4. To identify molecular prognostic indicators suitable for patient stratification in future trials.
5. To evaluate the HRQOL during phases of active treatment specific to treatment modalities.
6. To describe the neuropsychological functioning of the study population and to evaluate the relationship
between neuropsychological status and health related quality of life.

Age at least 3 years and les than 22 years at time of diagnosis. Newly diagnosed, previously untreated 1) M0 Medulloblastoma with >1.5 cm2 residual, 2) M+ Medulloblastoma, 3) M0 or M+ Supratentorial PNET. Patients with anaplastic medulloblastoma are eligible regardless of M-stage or residual tumor. All patients with M4 disease are not eligible.

Protocol Number110712
Principal InvestigatorRichard Drachtman
PhasePhase III
ScopeNational
Applicable Disease SitesBrain and Nervous System
Therapies InvolvedChemotherapy multiple agents systemic
Chemotherapy single agent systemic
Radiotherapy
Drugs InvolvedCISPLATIN
VINCRISTINE
ISOTRETINOIN
CARBOPLATIN
CYCLOPHOSPHAMIDE
Participating InstitutionsRobert Wood Johnson University Hospital in New Brunswick
Robert Wood Johnson Medical School

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.