boron neutron capture therapy following surgery in treating patients with glioblastoma multiforme removed during surgery

Conditions: Brain and Central Nervous System Tumors

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.

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.

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

Keywords: adult glioblastoma adult giant cell glioblastoma adult gliosarcoma