Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase II Study of Temozolomide in the Treatment of Recurrent Malignant Gliomas
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who
have recurrent or progressive malignant glioma.
OBJECTIVES:
- Determine the progression-free survival and response rate of patients with recurrent or
progressive malignant glioma treated with temozolomide.
- Determine whether certain categories of malignant gliomas, such as oligodendroglioma,
are more sensitive to temozolomide.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients are stratified according to histologic categories (recurrent glioblastoma
multiforme [closed to accrual 11/30/01] vs recurrent anaplastic astrocytoma vs recurrent
anaplastic oligodendroglioma).
Patients receive oral temozolomide twice daily for 5 consecutive days. Courses repeat every
28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.
;
Primary Purpose: Treatment
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