Temozolomide in Treating Patients With Progressive Low-Grade Glioma

Brain and Central Nervous System Tumors Clinical Trial

Official title: Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal

Status Completed

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with progressive low-grade glioma.

Clinical Trial Description

OBJECTIVES:

• Assess the response rate in patients with progressive low-grade gliomas treated with temozolomide.

• Determine the activity of this drug, in terms of stabilizing growth of progressive low-grade gliomas, in adult patients.

OUTLINE: Patients are stratified by disease type (pilocytic astrocytoma, mixed glioma, well-differentiated oligodendroglioma, and nonbiopsied optic pathway glioma or pontine glioma).

Patients receive temozolomide orally once daily on days 1-5. Courses repeat every 28 days. In the absence of disease progression or unacceptable toxicity, patients may continue with treatment until tumor has remained stable for 12 courses.

Patients are followed every 8-12 weeks for 2 years.

PROJECTED ACCRUAL: A total of 36-100 patients (9-25 per stratum) will be accrued for this study within 3 years. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

• NCT number: NCT00003466
• Study type: Interventional
• Source: Duke University
• Status: Completed
• Phase: Phase 2
• Start date: March 1998
• Completion date: July 2005