Brain Tumors Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor
cells. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of etoposide plus radiation therapy
followed by combination chemotherapy in treating children with newly diagnosed advanced
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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