Melanoma (Skin) Clinical Trial
Official title:
Early Phase II Study On BNCT In Metastatic Malignant Melanoma Using The Boron Carrier BPA
RATIONALE: Boron neutron capture therapy using boronophenylalanine-fructose complex may kill
tumor cells without harming normal tissue.
PURPOSE: This phase II trial is studying how well boron neutron capture therapy using
boronophenylalanine-fructose complex works in treating patients with metastatic melanoma.
OBJECTIVES:
Primary
- Determine the therapeutic activity and efficacy of boron neutron capture therapy using
boronophenylalanine-fructose complex in patients with metastatic melanoma.
- Determine the objective local response in patients treated with this regimen.
Secondary
- Determine the overall survival of patients treated with this regimen.
- Determine the duration of local response and time to local progression in patients
treated with this regimen.
- Determine the dose-response relationship at the per-lesion level in patients treated
with this regimen.
- Determine the safety of this regimen in these patients.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive boronophenylalanine-fructose complex IV over 90 minutes followed by boron
neutron capture therapy on days 1 and 2.
Patients are followed at 1 and 6 weeks and then every 8 weeks thereafter. In the event of
disease progression, patients are followed every 3 months for survival.
PROJECTED ACCRUAL: A total of 16-24 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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