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
|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 [ Designated as safety issue: Yes ]
- Late toxicity as measured by RTOC and EORTC late radiation morbidity scale from 90 days after completion of irradiation treatment until death [ Designated as safety issue: Yes ]
- Overall survival as measured by Logrank until death [ Designated as safety issue: No ]
|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|