Brain and Central Nervous System Tumors, Melanoma (Skin), Metastatic Cancer
Conditions
Keywords
adult glioblastoma, stage IV melanoma, tumors metastatic to brain, adult giant cell glioblastoma, adult gliosarcoma
Brief summary
RATIONALE: Radiation therapy such as boron neutron capture therapy may kill tumor cells without harming normal tissue. PURPOSE: Phase I/II trial to study the effectiveness of boron neutron capture therapy in treating patients who have glioblastoma multiforme or melanoma metastatic to the brain.
Detailed description
OBJECTIVES: * Determine the time course, uniformity, and severity of acute and chronic normal tissue reactions in patients with glioblastoma multiforme or intracranial melanoma treated with boronophenylalanine-fructose complex (BPA-f) followed by cranial neutron irradiation using a new fission converter beam facility. * Determine the maximum tolerated dose of cranial neutron capture therapy in these patients. * Determine, through serial objective measurements, the clinical response in patients treated with this therapy. * Determine the pharmacokinetics of BPA-f in these patients. OUTLINE: This is a dose-escalation study of cranial neutron capture therapy (NCT). Patients receive boronophenylalanine-fructose complex IV over 90 minutes followed by cranial NCT on days 1 and 2. Cohorts of 3-6 patients receive escalating doses of NCT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the MTD. Patients are followed at 1, 2, 4, 6, 9, and 12 months and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 16 patients will be accrued for this study within 2 years.
Interventions
Sponsors
National Cancer Institute (NCI)
Beth Israel Deaconess Medical Center
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed glioblastoma multiforme OR * Radiographically diagnosed brain metastases after a diagnosis of melanoma * Contrast-enhanced tumor volume must not exceed 60 mL PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 6 months Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Creatinine normal Cardiovascular: * No prior severe cardiac disease, including the following: * Uncontrolled arrhythmias or conduction defects * Unstable or newly diagnosed angina pectoris * Recent coronary artery disease * Congestive heart failure Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 6 months after study * No prior phenylketonuria * No cognitive impairment that would preclude informed consent PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior cranial irradiation Surgery: * Not specified
Countries
United States
Outcome results
None listed