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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
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
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 cm² 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 cm² residual tumor vs M+ medulloblastoma vs M0 supratentorial primitive neuroectodermal tumor [SPNET] with less than 1.5 cm² residual tumor vs M0 SPNET with greater than 1.5 cm² 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
01/24/2017 05:03 AM
 

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