Boron Neutron Capture Therapy Using Boronophenylalanine-Fructose Complex in Treating Patients With Metastatic Melanoma
Melanoma (Skin)
About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma
Eligibility 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
Sites / Locations
- Universitaetsklinikum Essen