A Phase I/II Feasibility Study of Oral Etoposide Given Concurrently With Radiotherapy Followed With Dose Intensive Adjuvant Chemotherapy for Children With Newly Diagnosed High Stage Medulloblastoma

Trial Information

A Phase I/II Feasibility Study of Oral Etoposide Given Concurrently With Radiotherapy Followed With Dose Intensive Adjuvant Chemotherapy for Children With Newly Diagnosed High Stage Medulloblastoma

OBJECTIVES:

- Assess the response rate and toxicity of oral etoposide and radiotherapy in children
with newly diagnosed high stage medulloblastoma.

- Compare the response rate and toxicity of these patients to historical control patients
registered on POG #9031.

- Estimate the 2-year event-free survival and overall survival of these patients.

- Evaluate the toxicity of dose intensive chemotherapy with oral etoposide, cisplatin,
cyclophosphamide, and vincristine following craniospinal irradiation in these patients.

OUTLINE: Patients begin treatment within 1 month of surgery. Patients receive 6 weeks of
radiotherapy to the head and spine, with boosts to the posterior fossa and to sites of
metastasis. Patients also receive 2 courses of oral etoposide once daily for 3 weeks
concurrent with and immediately following radiotherapy (weeks 1-3 and 5-7).

Patients then receive adjuvant chemotherapy consisting of cisplatin IV once every 4 weeks
for 3 courses beginning on week 11, oral etoposide daily for 21 days every 4 weeks for 3
courses (weeks 11, 15, and 19), cyclophosphamide IV on days 1 and 2 with filgrastim (G-CSF)
SQ daily for at least 10 days every 4 weeks for 8 courses (weeks 23-51), and vincristine IV
on days 1, 8, and 15 every 4 weeks for 8 courses (weeks 23-51).

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
for 1 year, and annually thereafter.

PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within about 2
years.