Clinical Trial Finder

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

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.