RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue. PURPOSE: Phase II trial to study the effectiveness of boron neutron capture therapy in treating patients who have melanoma.
OBJECTIVES: * Determine the clinical response, by serial objective measurements, in patients with melanoma treated with boron neutron capture therapy. * Determine the time course, uniformity, and severity of acute dermal reactions in patients treated with this regimen. * Determine the late dermal reactions in patients who are followed for at least 6 months after treatment with this regimen. * Determine the pharmacokinetics of this regimen in these patients. OUTLINE: Patients are stratified according to tumor size (no greater than 15 cc vs greater than 15 cc). Patients undergo boron neutron capture therapy. Patients are followed for 3 years. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 3 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Massachusetts Institute of Technology
Cambridge, Massachusetts, United States
Clinical response
Time course, uniformity, and severity of acute dermal reactions
Late dermal reaction after at least six months
Pharmacokinetics
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