Neuroblastoma Clinical Trial
Official title:
Phase II Treatment of Children With Newly Diagnosed Malignant Central Nervous System Tumors With Temozolomide Prior to Radiation Therapy
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. Chemotherapy combined with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by radiation
therapy in treating children who have newly diagnosed malignant central nervous system
tumors.
OBJECTIVES:
- 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
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