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

Brain and Central Nervous System Tumors Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioblastoma
• Nervous System Neoplasms

• NCT number: NCT00014677
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: March 2001
• Completion date: July 2008