Brain and Central Nervous System Tumors Clinical Trial
Official title:
Open Label Phase II Study On Glufosfamide Administered As A 60 Minute Infusion Every 3 Weeks In Recurrent Glioblastoma Multiforme
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.
;
Primary Purpose: Treatment
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