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Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme

2014-08-27 03:58:40 | BioPortfolio

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.

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

Conditions

Brain and Central Nervous System Tumors

Intervention

temozolomide, radiation therapy

Location

Duke Comprehensive Cancer Center
Durham
North Carolina
United States
27710

Status

Completed

Source

Duke University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:40-0400

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