Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients
This randomized phase III trial is studying different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma or supratentorial primitive neuroectodermal tumor.
Histologically confirmed diagnosis of medulloblastoma or supratentorial primitive neuroectodermal tumor (PNET) Newly diagnosed disease Previously untreated disease Meets 1 of the following criteria: M0 medulloblastoma with greater than 1.5 cmÂ² residual tumor M+ medulloblastoma M0 or M+ supratentorial PNET Diffusely anaplastic medulloblastoma with any M-stage or residual tumor Must have undergone stereotactic biopsy or attempted neurosurgical resection of the tumor within the past 31 days Good Health Normal Labs
This is a randomized, open-label, factorial-designed, multicenter study. Patients are stratified according to location of disease and dissemination status (M0 medulloblastoma with greater than 1.5 cmÂ² residual tumor vs M+ medulloblastoma vs M0 supratentorial primitive neuroectodermal tumor [SPNET] with less than 1.5 cmÂ² residual tumor vs M0 SPNET with greater than 1.5 cmÂ² residual tumor vs M+ SPNET). Patients are randomized* to 1 of 4 treatment arms. Arm I (standard chemoradiotherapy and standard maintenance therapy): Arm II (standard chemoradiotherapy plus carboplatin and standard maintenance therapy): Arm III (standard chemoradiotherapy, standard maintenance therapy plus isotretinoin, and continuation therapy with isotretinoin): Arm IV (standard chemoradiotherapy plus carboplatin, standard maintenance therapy plus isotretinoin, and continuation therapy with isotretinoin):
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