Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme

Brain and Central Nervous System Tumors Clinical Trial

Official title: Phase II Treatment of Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme 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: Phase II trial to study the effectiveness of temozolomide in treating adults with newly diagnosed primary malignant glioblastoma multiforme.

Clinical Trial Description

OBJECTIVES:

• Determine the antitumor activity of temozolomide in adults with newly diagnosed glioblastoma multiforme.

• Define the relationship between tumor O6-alkylguanine-DNA alkyltransferase activity and tumor response in these patients.

• Define the relationship between tumor DNA mismatch repair activity and tumor response to temozolomide.

OUTLINE: Patients receive temozolomide orally once daily on days 1-5. Treatment courses are repeated every 28 days. In the absence of disease progression and toxicity, patients receive up to 4 courses of treatment prior to radiation therapy. After radiation therapy, patients demonstrating partial or complete response may receive an additional 12 courses of treatment.

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

PROJECTED ACCRUAL: This study will accrue 50 patients. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

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

• NCT number: NCT00003464
• Study type: Interventional
• Source: Duke University
• Status: Completed
• Phase: Phase 2
• Start date: September 1997
• Completion date: August 2003