Hepatic Arterial Infusion With Melphalan Compared With Standard Therapy in Treating Patients With Unresectable Liver Metastases Due to Melanoma

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed liver metastases secondary to cutaneous or ocular melanoma

• Unresectable disease

• Predominantly in the parenchyma of the liver

• Measurable disease by CT scan and/or MRI

• Limited unresectable extrahepatic disease allowed provided the life-limiting component of progressive disease is in the liver, including, but not limited to, any of the following:

• Up to 4 pulmonary nodules, each < 1 cm in diameter

• Retroperitoneal lymph nodes < 3 cm in diameter

• Less than 10 skin or subcutaneous metastases < 1 cm in diameter

• Asymptomatic bone metastases that are eligible for or have undergone palliative external-beam radiotherapy

• Solitary metastasis to any site that can be resected

PATIENT CHARACTERISTICS:

• Life expectancy ≥ 3 months

• ECOG performance status 0-2

• Bilirubin < 3.0 mg/dL

• PT within 2 seconds of upper limit of normal (ULN)

• AST/ALT ≤ 10 times ULN

• Platelet count > 75,000/mm^3

• Hematocrit > 27% (may be achieved with a transfusion)

• Absolute neutrophil count ≥ 1,300/mm^3

• Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 60 mL/min

• Fertile patients must use effective contraception

• Not pregnant or nursing

• Negative pregnancy test

• No history of congestive heart failure

• LVEF ≥ 40%

• No significant chronic obstructive pulmonary disease (COPD) or other chronic pulmonary restrictive disease

• FEV_1 ≥ 30%

• DLCO ≥ 40% of predicted

• Weight ≥ 35 kg

• No untreated active bacterial infection with systemic manifestations (e.g., malaise, fever, and leucocytosis)

• No severe allergic reactions to iodine contrast unless reaction can be controlled by antihistamines and/or steroids

• No known hypersensitivity to melphalan

• No positive serology for HIV, hepatitis B surface antigen, or hepatitis C antibody (pharmacokinetics portion of the study only)

• No known latex allergy

• No Childs B or C cirrhosis

• No evidence of portal hypertension by history, endoscopy, or radiological study

• No prior history of gastrinoma

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 1 month since prior chemotherapy, radiotherapy, or biologic therapy for this cancer and recovered

• No prior regionally delivered melphalan

• No prior Whipple procedure

• No concurrent immunosuppressive therapy

• No concurrent chronic anticoagulation therapy