Boron Neutron Capture Therapy Following Surgery in Treating Patients With Glioblastoma Multiforme Removed During Surgery
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.
|Brain and Central Nervous System Tumors||Drug: sodium borocaptate Procedure: adjuvant therapy||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Postoperative Treatment of Glioblastoma With BNCT at the Petten Irradiation Facility|
- Acute toxicity as measured by NCIC-Common Toxicity Criteria up to 30 days after the first BSH administration
- Late toxicity as measured by RTOC and EORTC late radiation morbidity scale from 90 days after completion of irradiation treatment until death
- Overall survival as measured by Logrank until death
|Study Start Date:||June 2002|
|Primary Completion Date:||July 2003 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004015
|Graz, Austria, A-8010|
|Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Nice, France, 06002|
|Essen, Germany, D-45122|
|Klinikum der Universitaet Muenchen - Grosshadern Campus|
|Munich, Germany, D-81377|
|Ospedale Santa Chiara Pisa|
|Pisa, Italy, 56100|
|Vrije Universiteit Medisch Centrum|
|Amsterdam, Netherlands, 1007 MB|
|EC Joint Research Centre - Institute for Energy|
|Petten, Netherlands, NL-1755 ZG|
|Study Chair:||Wolfgang Sauerwein, MD, PhD||Universitaetsklinikum Essen|