NCT00003731

Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors

First Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors, a Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 recurrent oligodendroglial tumors.

Detailed description

OBJECTIVES: I. Assess the therapeutic activity of temozolomide as first line chemotherapy in patients with recurrent oligodendroglial tumors after radiation therapy. II. Assess the objective response and duration of response of these patients given this treatment. III. Characterize the acute side effects of temozolomide in this patient population. OUTLINE: This is an open label, multicenter study. Patients receive oral temozolomide on days 1-5. Courses are repeated every 28 days. Treatment continues for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months until disease progression. PROJECTED ACCRUAL: A total of 15-33 patients will be accrued for this study.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	temozolomide

Timeline

• Start date: 1998-12-01
• Primary completion: 2001-01-01
• First posted: 2004-05-20
• Last updated: 2012-09-24

Locations

24 sites across 9 countries: Belgium, France, Germany, Italy, Netherlands, Portugal, Slovakia, Switzerland, United Kingdom