Melanoma (Skin) Clinical Trial
Official title:
PROCEDURES FOR BNCT PHASE-I STUDY OF MELANOMA IN THE EXTREMITIES
RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming
normal tissue.
PURPOSE: Phase I trial to study the effectiveness of boron neuron capture therapy in
treating patients with stage III melanoma.
OBJECTIVES: I. Estimate the maximum tolerated dose of neutron irradiation that can be given
in combination with borophenylalanine-fructose complex (BPA-F) in patients with stage III
melanoma. II. Evaluate the safety of this regimen. III. Evaluate tumor response to this
regimen.
OUTLINE: This is a dose-finding study. Patients receive a test dose of
borophenylalanine-fructose complex (BPA-F) for biodistribution studies and undergo punch
biopses of tumor and normal tissue to measure B-10 concentration. Later, a treatment dose of
BPA-F over 1 hour is followed by neutron irradiation. Groups of 3 patients receive escalated
doses of neutron irradiation until the maximum tolerated dose is determined. Patients who
complete protocol treatment and continue to meet the eligibility criteria may re-enter the
study, provided at least 6 months has elapsed since the completion of prior therapy and the
field boundary for the new irradiation site is seperated from the boundary of the previously
irradiated site. Patients are followed monthly for 12 months, then every 3-6 months as
needed.
PROJECTED ACCRUAL: Approximately 15 patients will be entered.
;
Primary Purpose: Treatment
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