Boron Neutron Capture Therapy Using Boronophenylalanine-Fructose Complex in Treating Patients With Metastatic Melanoma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed melanoma
• •* Metastatic disease
• •* Brain metastases, skin metastases, or soft tissue metastases of the head and neck or the extremities
• •* 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
• •* Lesion(s) ≥ 10 mm in diameter
• •Indication for palliative radiotherapy that is intended to be delivered as BNCT
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •Karnofsky 70-100%
• •Life expectancy
• •Not specified
• •Hematopoietic
• •Neutrophil count ≥ 2,000/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Hemoglobin ≥ 10 g/dL
• •Hepatic
• •Bilirubin ≤ 2.5 times upper limit of normal (ULN)\*
• •Transaminases ≤ 2.5 times ULN\*
• •Alkaline phosphatase ≤ 2.5 times ULN\* NOTE: \*Unless due to reversible reaction to antiseizure medication
• •Renal
• •Creatinine ≤ 2.5 times ULN
• •Blood urea nitrogen ≤ 2.5 times ULN
• •Cardiovascular
• •No congestive heart failure
• •No newly diagnosed or unstable angina pectoris
• •No uncontrolled arrhythmias
• •No uncontrolled conduction defects
• •No recent coronary artery disease
• •No other severe heart disease
• •Pulmonary
• •No severe pulmonary disease, including severe obstructive or restrictive lung disease
• •Other
• •No history of phenylketonuria
• •No severe gastrointestinal disease
• •No active peptic ulcer disease
• •No uncontrolled endocrine disease
• •No pre-existing serious mental or organic brain disease (e.g., epilepsy)
• •No psychological, familial, sociological, or geographical condition that would preclude study compliance
• •Able to travel to the Netherlands via public transportation
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •No concurrent immunologic or biologic therapy
• •No concurrent colony-stimulating factors (e.g., epoetin alfa or filgrastim \[G-CSF\])
• •Chemotherapy
• •No concurrent chemotherapy
• •Endocrine therapy
• •No concurrent hormonal therapy
• •Radiotherapy
• •No prior radiotherapy to site(s) proposed for study treatment
• •No other concurrent radiotherapy
• •Surgery
• •See Disease Characteristics
• •Other
• •Recovered from all prior anti-tumor therapy (excluding alopecia and sensitive peripheral neuropathy ≤ grade 2)
• •No other concurrent anticancer therapy
• •No other concurrent investigational drugs