Clinical Trials

Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor

Location:

Rochester, MN

Trial status:

Open for Enrollment

Why is this study being done?

OBJECTIVES: Primary - Determine whether carboplatin radiosensitization increases long-term, event-free survival of pediatric patients with newly diagnosed, previously untreated, high-risk medulloblastoma or supratentorial primitive neuroectodermal tumors. - Determine whether isotretinoin increases long-term, event-free survival of these patients. Secondary - Compare residual disease response to radiotherapy alone versus radiotherapy and carboplatin in these patients. - Identify molecular prognostic indicators suitable for patient stratification in future trials. OUTLINE: This is a randomized, open-label, factorial-designed, multicenter study. Patients are stratified according to location of disease and dissemination status (M0 medulloblastoma with > 1.5 cm² residual tumor vs M+ medulloblastoma vs M0 supratentorial primitive neuroectodermal tumor [SPNET] with < 1.5 cm² residual tumor vs M0 SPNET with > 1.5 cm² residual tumor vs M+ SPNET vs M0 diffusely anaplastic medulloblastoma ). Patients are randomized to 1 of 4 treatment arms. - Arm I (standard chemoradiotherapy and standard maintenance therapy): - Chemoradiotherapy: Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40 and receive vincristine IV over 1 minute on days 1, 8, 15, 22, 29, and 36. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy. - Maintenance therapy: Patients receive cisplatin IV over 6 hours on day 1, vincristine IV over 1 minute on days 1 and 8, and cyclophosphamide IV over 1 hour on days 2 and 3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) or IV beginning on day 4 and continuing until blood counts recover (at least 10 days). Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. - Arm II (standard chemoradiotherapy plus carboplatin and standard maintenance therapy): - Chemoradiotherapy: Patients receive carboplatin IV over 15 minutes once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40 and undergo radiotherapy and receive vincristine as in arm I. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy. - Maintenance therapy: Patients receive maintenance therapy as in arm I. - Arm III (standard chemoradiotherapy, standard maintenance therapy plus isotretinoin, and continuation therapy with isotretinoin): - Chemoradiotherapy: Patients undergo chemoradiotherapy as in arm I. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy. - Maintenance therapy: Patients receive oral isotretinoin twice daily on day 1 and days 16-28 and cisplatin, vincristine, cyclophosphamide, and G-CSF as in arm I maintenance therapy. Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to continuation therapy. - Continuation therapy: Patients receive oral isotretinoin twice daily on days 15-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. - Arm IV (standard chemoradiotherapy plus carboplatin, standard maintenance therapy plus isotretinoin, and continuation therapy with isotretinoin): - Chemoradiotherapy: Patients undergo chemoradiotherapy as in arm II. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy. - Maintenance therapy: Patients receive maintenance therapy as in arm III. Patients then proceed to continuation therapy. - Continuation therapy: Patients receive continuation therapy as in arm III. After completion of study treatment, patients are followed up periodically for up to 10 years. PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.

Last updated: 11/03/2012

NCT ID:

NCT00392327