NCT00004015

Boron Neutron Capture Therapy Following Surgery in Treating Patients With Glioblastoma Multiforme Removed During Surgery

Postoperative Treatment of Glioblastoma With BNCT at the Petten Irradiation Facility

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of boron neutron capture therapy following surgery in treating patients with glioblastoma multiforme removed during surgery.

Detailed description

OBJECTIVES: * Determine systemic and local toxicity of borocaptate sodium with boron neutron capture therapy (BNCT) following craniotomy with gross total resection in patients with glioblastoma multiforme. * Determine the qualitative and quantitative dose-limiting toxicity and maximum tolerated dose of this regimen in these patients. * Determine the maximum tolerated radiation dose of BNCT in cranial localization to healthy tissues in these patients under defined conditions. OUTLINE: This is a dose escalation, multicenter study. Within 6 weeks of surgery, patients receive borocaptate sodium followed 12-18 hours later by neutron irradiation. Treatment repeats daily for 4 days. Cohorts of 3-9 patients receive escalating doses of neutron irradiation. The maximum tolerated dose is defined as the dose preceding that at which 3 or more patients experience dose limiting toxicity. Patients are followed weekly for 4 weeks, monthly for 2 months, every 6 weeks for 15 months and then every 3 months thereafter. PROJECTED ACCRUAL: Approximately 30-36 patients will be accrued for this study.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	sodium borocaptate
PROCEDURE	adjuvant therapy

Timeline

• Start date: 2002-06-01
• Primary completion: 2003-07-01
• First posted: 2003-01-27
• Last updated: 2012-07-18

Locations

8 sites across 6 countries: Austria, Canada, France, Germany, Italy, Netherlands