Spots Global Cancer Trial Database for Boron Neutron Capture Therapy Following Surgery in Treating Patients With Glioblastoma Multiforme Removed During Surgery

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Trial Identification

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

Official Title: Postoperative Treatment of Glioblastoma With BNCT at the Petten Irradiation Facility

Study ID: NCT00004015

Conditions

Brain and Central Nervous System Tumors

Interventions

sodium borocaptate

adjuvant therapy

Study Description

Brief 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.