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About
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.
Full description
OBJECTIVES:
Primary
Secondary
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed melanoma
Metastatic disease
Accessible lesion(s) for boron neutron capture therapy (BNCT)
No clear progression of disease at other sites than the ones intended for treatment with surgery and/or BNCT
Measurable disease by MRI within the past 4 weeks
Indication for palliative radiotherapy that is intended to be delivered as BNCT
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Data sourced from clinicaltrials.gov
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