Melanoma (Skin) Clinical Trial
Official title:
A Phase II Trial For Neutron Capture Therapy In Melanoma
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.
;
Allocation: Non-Randomized, Primary Purpose: Treatment
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