CNS Tumor, Adult Clinical Trial
Official title:
A Phase II Study of Temozolomide (TEMODAR) in the Treatment of Adult Patients With Supratentorial Low Grade Glioma
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well temozolomide works in treating 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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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