Spots Global Cancer Trial Database for Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme

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Trial Identification

Brief Title: Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme

Official Title: Open Label Phase II Study On Glufosfamide Administered As A 60 Minute Infusion Every 3 Weeks In Recurrent Glioblastoma Multiforme

Study ID: NCT00014300

Conditions

Brain and Central Nervous System Tumors

Interventions

glufosfamide

Study Description

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.