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

Phase 1

Completed

• Conditions: Brain and Central Nervous System Tumors

• Registration Number: NCT00004015
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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.

Study Timeline

• Study First Submitted: 1999-11-01
• Study Start: 2002-06
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2003-07
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-17
• Last Update Posted: 2012-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute toxicity as measured by NCIC-Common Toxicity Criteria up to 30 days after the first BSH administration

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

Karl-Franzens-University Graz; 🇦🇹 Graz, Austria

Universitaetsklinikum Essen; 🇩🇪 Essen, Germany

Vrije Universiteit Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

EC Joint Research Centre - Institute for Energy; 🇳🇱 Petten, Netherlands

Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Hopital Pasteur; 🇫🇷 Nice, France

Klinikum der Universitaet Muenchen - Grosshadern Campus; 🇩🇪 Munich, Germany

Ospedale Santa Chiara Pisa; 🇮🇹 Pisa, Italy