Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase I/II Trial For Neutron Capture Therapy In Glioblastoma Multiforme And Intracranial Melanoma

Conditions
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Melanoma (Skin), Brain and Central Nervous System Tumors, Metastatic Cancer

Intervention / Treatment
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* Drug: boronophenylalanine-fructose complex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: boronophenylalanine-fructose complex|nan|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult glioblastoma, stage IV melanoma, tumors metastatic to brain, adult giant cell glioblastoma, adult gliosarcoma