A Randomized, Dose-Ranging, Safety and Tolerability Study of NBI-3001 Administered by Continuous Intratumoral Infusion Followed by Surgical Resection in Patients With Recurrent 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.
Primary Purpose: Treatment
Henry Pan, MD, PhD
United States: Federal Government
|Emory University Hospital - Atlanta||Atlanta, Georgia 30322|
|St. Louis University Health Sciences Center||Saint Louis, Missouri 63110-0250|
|Charlotte Neurosurgical Associates||Charlotte, North Carolina 28207-1830|
|UCSD Thornton Hospital||La Jolla, California 92037|