RATIONALE: NBI-3001 may be able to locate cancer cells and stop them from growing. This may be an effective treatment for glioblastoma multiforme. PURPOSE: Randomized phase II trial to compare different regimens of NBI-3001 followed by surgery to remove the tumor in treating patients who have glioblastoma multiforme.
OBJECTIVES: I. Determine the safety, tolerability, and optimal clinical dose of interleukin-4(38-37)-PE38KDEL cytotoxin (NBI-3001) followed by surgical resection in patients with recurrent glioblastoma multiforme. OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients receive interleukin-4(38-37)-PE38KDEL cytotoxin (NBI-3001) intratumorally as a continuous infusion over 4-5 days beginning within 12-36 hours after ventricular catheter placement. Patients then undergo surgical tumor resection approximately 3 weeks after drug infusion. Cohorts of 6 patients receive escalating doses of NBI-3001 until the maximum tolerated dose is determined. Patients are followed within 1 week and then at 8, 16, and 26 weeks. PROJECTED ACCRUAL: Approximately 30-36 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
UCSD Thornton Hospital
La Jolla, California, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
St. Louis University Health Sciences Center
St Louis, Missouri, United States
Charlotte Neurosurgical Associates
Charlotte, North Carolina, United States
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