Brain and Central Nervous System Tumors
Conditions
Keywords
adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
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.
Interventions
PROCEDUREadjuvant therapy
Sponsors
European Organisation for Research and Treatment of Cancer - EORTC
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute toxicity as measured by NCIC-Common Toxicity Criteria up to 30 days after the first BSH administration | — |
Secondary
| Measure | 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 | — |
Countries
Austria, Canada, France, Germany, Italy, Netherlands
Outcome results
None listed