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.
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 Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
32
Kaiser Franz Josef Hospital
Vienna (Wien), Austria
Centre Jean Perrin
Clermont-Ferrand, France
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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
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Paris, France
Centre Eugene Marquis
Rennes, France
Institut Gustave Roussy
Villejuif, France
University of Ioannina
Ioannina, Greece
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