NCT00014677

NBI-3001 Followed by Surgery in Treating Patients With Recurrent Glioblastoma Multiforme

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
BIOLOGICAL	interleukin-4 PE38KDEL cytotoxin
PROCEDURE	conventional surgery

Timeline

• Start date: 2001-03-01
• Primary completion: 2002-09-01
• Completion: 2008-07-01
• First posted: 2003-11-13
• Last updated: 2013-07-18

Locations

4 sites across 1 country: United States