Imatinib Mesylate in Treating Patients With Gliomas

Phase 2

Completed

• Conditions: Brain and Central Nervous System Tumors

• Registration Number: NCT00039364
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and slow the growth of the tumor.

PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have gliomas.

Detailed Description

OBJECTIVES:

* Determine the therapeutic activity of imatinib mesylate (in terms of objective response and progression-free survival at 6 months) in patients with gliomas.

* Determine the safety of this drug in these patients.

* Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to glioma (glioblastoma multiforme vs anaplastic oligodendroglioma or mixed oligoastrocytoma vs anaplastic astrocytoma or recurrent low-grade astrocytoma).

Patients receive oral imatinib mesylate once or twice daily. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 6 months and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 77 patients (29 patients with glioblastoma multiforme, 24 patients with anaplastic oligodendroglioma or mixed oligoastrocytoma, and 24 patients with anaplastic astrocytoma or recurrent low-grade astrocytoma) will be accrued for this study.

Study Timeline

• Study Start: 2002-03
• Study First Submitted: 2002-06-06
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-08
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-23
• Last Update Posted: 2012-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (10)

CRLCC Nantes - Atlantique; 🇫🇷 Nantes-Saint Herblain, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Kaiser Franz Josef Hospital; 🇦🇹 Vienna, Austria

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

Beatson Oncology Centre; 🇬🇧 Glasgow, Scotland, United Kingdom

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

Daniel Den Hoed Cancer Center at Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Centre de Lutte Contre le Cancer, Georges-Francois Leclerc; 🇫🇷 Dijon, France

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland