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Title:

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

Protocol Number:

PACNS0332

Phase:

Phase III

Physician:

Kenneth Cohen

Purpose:

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.

Eligibility:

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

Treatment:

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):

Population:

Pediatric

Last Update

05/24/2013 04:02 AM

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