NCT00313729

Temozolomide in Treating Patients With Low-Grade Glioma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• CNS Tumor, Adult

Interventions

Type	Name	Description
DRUG	temozolomide	Chemotherapy

Timeline

• Start date: 1999-05-01
• Primary completion: 2014-09-25
• Completion: 2017-06-12
• First posted: 2006-04-12
• Last updated: 2019-02-07
• Results posted: 2019-01-23

Locations

1 site across 1 country: United States