NCT00014300

Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	glufosfamide

Timeline

• Start date: 2001-01-01
• Primary completion: 2001-09-01
• First posted: 2004-03-17
• Last updated: 2012-09-24

Locations

18 sites across 8 countries: Austria, France, Greece, Israel, Italy, Netherlands, Portugal, Switzerland