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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Universitaetsklinikum Essen
Essen, Germany
Best response to treatment as measured by RECIST every 8 weeks at completion of study treatment
Overall survival as measured every 8 weeks at completion of study treatment
Duration of local response as measured by Kaplan Meier every 8 weeks after completion of study treatment
Time to local progression measured every 8 weeks after completion of study treatment
Acute toxicity as measured by Common Toxicity Criteria AE v 3.0 1- 6 weeks after completion of treatment
Late toxicity as measured by RTOG and EORTC week 6 and thereafter upon completion of study treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.