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

Study Overview
=================
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.

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

Conditions
-----------------
Brain and Central Nervous System Tumors

Intervention / Treatment
-----------------
* Drug: sodium borocaptate
* Procedure: adjuvant therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically proven glioblastoma multiforme for which conventional radiotherapy would be of little or no benefit Gross total resection of tumor confirmed by postoperative MRI performed within 48 hours of surgery Evaluable preoperative and postoperative MRI films with and without contrast must be available No prior brain malignancy No prior craniotomy except for glioblastoma PATIENT CHARACTERISTICS: Age: 50 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin, SGOT, SGPT, and alkaline phosphatase no greater than 2.5 times normal unless caused by reversible reaction to antiseizure medication Renal: Blood urea nitrogen and creatinine no greater than 2.5 times upper limit of normal Cardiovascular: No severe heart disease (e.g., congestive heart failure, angina pectoris) Pulmonary: No severe dyspnea at time of diagnosis No severe obstructive or restrictive lung disease Other: No other concurrent malignant tumor No severe gastrointestinal disease or active peptic ulcer disease No uncontrolled endocrine disease No serious mental disease, organic brain disease (e.g., preexisting epilepsy or serious aphasia), or legally incapacitated patients PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for glioblastoma multiforme No concurrent biologic therapy Chemotherapy: No prior chemotherapy for glioblastoma multiforme No concurrent chemotherapy Endocrine therapy: No prior endocrine therapy for glioblastoma multiforme except corticosteroids No concurrent endocrine therapy Radiotherapy: See Disease Characteristics No prior radiotherapy for glioblastoma multiforme No prior radiotherapy to head and neck No other concurrent radiotherapy Surgery: See Disease Characteristics Prior stereotactic biopsy allowed for glioblastoma multiforme

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sodium borocaptate|nan|
|Procedure: adjuvant therapy|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity as measured by NCIC-Common Toxicity Criteria up to 30 days after the first BSH administration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma