Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme

Phase 2

Completed

• Conditions: Brain and Central Nervous System Tumors

• Registration Number: NCT00014300
• 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 glufosfamide in treating patients who have recurrent glioblastoma multiforme.

Detailed Description

OBJECTIVES: I. Determine the activity of glufosfamide, in terms of objective response rate and/or progression-free survival at 6 months, in patients with recurrent glioblastoma multiforme. II. Determine the duration of objective response in patients treated with this regimen. III. Determine the toxic effects and pharmacokinetic profile of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive glufosfamide IV over 60 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease receive treatment for a minimum of 6 months or until progression. Patients with an objective complete response receive a maximum of 2 additional courses of treatment after confirmation of response. Patients are followed every 6 weeks until progression.

PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.

Study Timeline

• Study Start: 2001-01
• Study First Submitted: 2001-04-10
• Primary Completion: 2001-09
• Study First Submitted QC: 2004-03-16
• Study First Posted: 2004-03-17
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-20
• Last Update Posted: 2012-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (18)

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

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

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

Centre Leon Berard; 🇫🇷 Lyon, France

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

Centre Antoine Lacassagne; 🇫🇷 Nice, France

CHU Pitie-Salpetriere; 🇫🇷 Paris, France

Centre Eugene Marquis; 🇫🇷 Rennes, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

University of Ioannina; 🇬🇷 Ioannina, Greece

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