Trial Information

Dose Intensive Chemotherapy for Patients Greater Than or Equal To 10 Years of Age With Newly Diagnosed High Stage Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumors (PNET) and Ependymoma: A Feasibility Study of an Intensive Induction Chemotherapy Regimen Followed by Standard Irradiation

OBJECTIVES:

- Determine the toxicity of adjuvant dose-intensive induction chemotherapy with
cisplatin, vincristine, cyclophosphamide, and etoposide with or without methotrexate
followed by standard radiotherapy in patients with surgically resected, newly diagnosed
high stage medulloblastoma or supratentorial primitive neuroectodermal tumor, or
incompletely resected ependymoma.

- Determine the response rate, time to progression, overall survival, and pattern of
failure in these patients treated with this regimen.

OUTLINE: Patients receive dose-intensive induction chemotherapy consisting of cisplatin IV
over 6 hours on day 0; vincristine IV on days 0, 7, and 14; and etoposide and
cyclophosphamide IV over 1 hour on days 1 and 2. Patients with M1+ disease (i.e., evidence
of dissemination beyond primary tumor site) also receive methotrexate IV over 4 hours on day
3. Patients receive filgrastim (G-CSF) subcutaneously daily beginning on day 7 and
continuing until blood counts recover. Chemotherapy continues every 21-28 days for a total
of 3 courses in the absence of disease progression or unacceptable toxicity. Patients then
undergo radiotherapy 5 days a week for 6.5 weeks beginning 3-6 weeks after completion of
chemotherapy.

Patients are followed at 6 weeks, then every 3 months for 2 years, every 4 months for 1
year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 6-20 patients will be accrued for this study.