Clinical Trial: Temozolomide in Treating Patients With Anaplastic Oligodendroglioma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Treatment of Adults With Newly Diagnosed, Progressive or Recurrent Primary Malignant Anaplastic Oligodendroglioma With Temodal

Brief 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 patients with anaplastic oligodendroglioma.

Detailed Summary:

OBJECTIVES: I. Determine the activity of temozolomide in patients with newly diagnosed, progressive, or recurrent anaplastic oligodendroglioma. II. Determine the toxicity of this drug in this patient population.

OUTLINE: Patients are stratified according to disease characteristics (newly diagnosed anaplastic oligodendroglioma versus recurrent anaplastic oligodendroglioma). Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days. Patients with progressive or recurrent disease (at baseline) continue treatment in the absence of disease progression or unacceptable toxicity. Patients with newly diagnosed disease continue treatment for a maximum of 4 courses before radiotherapy in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive an additional 6 courses after completion of radiotherapy. (Radiotherapy is not part of study treatment.) Patients are followed every 8 weeks for 2 years.

PROJECTED ACCRUAL: A maximum of 60 patients (30 per stratum) will be accrued for this study.

Sponsor: Duke University

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Duke University

Dates:
Date Received: November 1, 1999
Date Started: March 1998
Date Completion:
Last Updated: June 19, 2013
Last Verified: October 2009