A Phase II Study of Temozolomide (TEMODAR) in the Treatment of Adult Patients With Supratentorial Low Grade Glioma
OBJECTIVES:
Primary
- Determine the efficacy of temozolomide, defined as response rate (complete and partial
response), in patients with supratentorial mixed low-grade glioma.
Secondary
- Assess the safety profile of temozolomide in patients with supratentorial low-grade
glioma.
- 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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (complete and partial response)
Years
No
Susan M. Chang, MD
Study Chair
University of California, San Francisco
United States: Food and Drug Administration
CDR0000448883
NCT00313729
May 1999
Name | Location |
---|---|
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |