Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors

Phase 2

Completed

• Conditions: Brain and Central Nervous System Tumors

• Registration Number: NCT00003304
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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 recurrent oligodendroglial tumors following combination chemotherapy.

Detailed Description

OBJECTIVES: I. Determine the response rate and duration of response in oligodendroglial tumors to temozolomide treatment in patients with progressive disease during or after procarbazine/lomustine/vincristine (PCV) chemotherapy. II. Determine the feasibility and toxicity of temozolomide chemotherapy following PVC chemotherapy in these patients.

OUTLINE: This is an open label, multicenter trial. Temozolomide is administered orally on days 1-5 of each 4-week course; treatment continues for a maximum of 12 courses. Patients are followed every 2 months for the first 6 months and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 16-29 patients will be accrued for this study.

Study Timeline

• Study Start: 1998-04
• Study First Submitted: 1999-11-01
• Primary Completion: 2000-03
• Study First Submitted QC: 2004-08-25
• Study First Posted: 2004-08-26
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-05
• Last Update Posted: 2012-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (37)

Kaiser Franz Josef Hospital; 🇦🇹 Vienna (Wien), Austria

Hopital Universitaire Erasme; 🇧🇪 Brussels, Belgium

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

Turku University Central Hospital; 🇫🇮 Turku, Finland

Institut Bergonie; 🇫🇷 Bordeaux, France

Centre Regional Francois Baclesse; 🇫🇷 Caen, France

Hopital Louis Pasteur; 🇫🇷 Colmar, France

Centre Hospitalier Universitaire de Bicetre; 🇫🇷 Le Kremlin Bicetre, France

Centre Leon Berard; 🇫🇷 Lyon, France

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