Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase II Study of Temozolomide (SCH 52365, Temodal(R)) for the Treatment of Recurrent Malignant Glioma
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 malignant glioma.
OBJECTIVES: I. Determine the safety and efficacy of temozolomide in patients with recurrent
malignant glioma. II. Determine the radiographic response to this regimen in these patients.
III. Determine the time to tumor progression of these patients on this regimen. IV.
Determine the quality of life of these patients.
OUTLINE: Patients receive oral temozolomide once daily for 42 days. Courses repeat every 70
days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed every 1-2 months. Patients are followed every 3-4 months.
PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 2 years.
;
Primary Purpose: Treatment
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