Phase II Treatment of Children With Newly Diagnosed Malignant Central Nervous System Tumors With Temozolomide Prior to Radiation Therapy
- Determine the response rate to treatment with temozolomide in children with newly
diagnosed malignant central nervous system tumors.
- Determine the toxicity of this treatment in these patients.
- Determine the overall survival in these patients for 18 months following the study
after receiving this treatment.
OUTLINE: Patients are stratified according to type of disease (ependymoma vs brain stem
glioma vs malignant glioma vs other).
Patients receive oral temozolomide on days 1-5. Treatment repeats every 28 days for a
maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
Patients with a partial or complete response may receive an additional 8 courses of
temozolomide following radiotherapy.
PROJECTED ACCRUAL: A maximum of 100 patients (25 per stratum) will be accrued for this study
over 24-36 months.
Primary Purpose: Treatment
Henry S. Friedman, MD
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|