Spots Global Cancer Trial Database for Temozolomide in Treating Patients With Low-Grade Glioma

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Trial Identification

Brief Title: Temozolomide in Treating Patients With Low-Grade Glioma

Official Title: A Phase II Study of Temozolomide (TEMODAR) in the Treatment of Adult Patients With Supratentorial Low Grade Glioma

Study ID: NCT00313729

Conditions

CNS Tumor, Adult

Interventions

temozolomide

Study Description

Brief Summary: 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.

Detailed Description: 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.