A Phase II Study of Temozolomide (TEMODAR) in the Treatment of Adult Patients With Supratentorial Low Grade Glioma
- Determine the efficacy of temozolomide, defined as response rate (complete and partial
response), in patients with supratentorial mixed low-grade glioma.
- Assess the safety profile of temozolomide in patients with supratentorial low-grade
- Assess the time to tumor progression in patients treated with temozolomide.
OUTLINE: Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every
28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year, every
4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (complete and partial response)
Susan M. Chang, MD
University of California, San Francisco
United States: Food and Drug Administration
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|