Hepatic Arterial Infusion of Melphalan With Hepatic Perfusion in Treating Patients With Unresectable Liver Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed hepatic malignancy
• •* Unresectable disease
• •* Disease predominantly in the parenchyma of the liver
• •* One of the following primary tumor histologies:
• •* Adenocarcinoma of gastrointestinal or other origin
• •* Neuroendocrine tumor (except gastrinoma)
• •* Primary hepatic malignancy (e.g., hepatocellular cancer or intra-hepatic cholangiocarcinoma)
• •* Cutaneous or ocular melanoma (patients must have received prior regional melphalan therapy)
• •* Hepatic metastases from colorectal tumors allowed provided patient has undergone prior first-line chemotherapy, including irinotecan or oxaliplatin
• •Limited unresectable extrahepatic disease on preoperative radiological studies allowed if life-limiting component of progressive disease is in the liver
• •* Limited extrahepatic disease includes, but is not limited to, the following:
• •* Up to 4 pulmonary nodules each \< 1 cm in diameter
• •* Retroperitoneal lymph nodes each \< 3 cm in diameter
• •* Less than 10 skin or subcutaneous metastases each \< 1 cm in diameter
• •* Asymptomatic bone metastases that have been or could be palliatively treated with external beam radiotherapy
• •* Resectable solitary metastasis to any site
• •Hormone receptor status:
• •* Not specified
• •PATIENT CHARACTERISTICS:
• •Age
• •16 and over
• •Sex
• •Male or Female
• •Menopausal status
• •Not specified
• •Performance status
• •ECOG 0-2
• •Life expectancy
• •Not specified
• •Hematopoietic
• •Platelet count ≥ 75,000/mm\^3
• •Hematocrit \> 27%
• •Absolute neutrophil count ≥ 1,300/mm\^3
• •Hepatic
• •Bilirubin ≤ 2.0 mg/dL
• •PT ≤ 2 seconds of upper limit of normal (ULN)
• •AST and ALT ≤ 10 times ULN
• •No Childs class B or C cirrhosis
• •No portal hypertension by history, endoscopy, or radiologic studies
• •Renal
• •Creatinine ≤ 1.5 mg/dL OR
• •Creatinine clearance \> 60 mL/min
• •Cardiovascular
• •No congestive heart failure
• •LVEF ≥ 40%
• •Pulmonary
• •No chronic obstructive pulmonary disease
• •FEV\_1 ≥ 30% of predicted
• •DLCO ≥ 40% of predicted
• •Immunologic
• •No active infection
• •No severe allergic reaction to iodine contrast agent that is not controlled by premedication with antihistamines or steroids
• •No known hypersensitivity reaction to melphalan or heparin in the presence of a heparin induced thrombocytopenia (HIT) antibody
• •Other
• •Weight \> 35 kg
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No documented latex allergy
• •No evidence of intracranial abnormalities which would lead to risk for bleeding with anticoagulation (e.g., stroke or active metastasis)
• •No evidence of active ulcer disease
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •More than 1 month since prior biologic therapy and recovered
• •Chemotherapy
• •See Disease Characteristics
• •More than 1 month since prior chemotherapy and recovered
• •Endocrine therapy
• •Premenopausal women (i.e., have had a period within the past 12 months) must be willing to undergo hormonal suppression during study treatment
• •Radiotherapy
• •See Disease Characteristics
• •More than 1 month since prior radiotherapy and recovered
• •Surgery
• •No prior Whipple resection
• •Other
• •Prior intrahepatic perfusion (with or without arterial infusion with floxuridine) or peripheral hepatic perfusion allowed provided the patient had a radiographic partial response of 3 months' duration after therapy
• •No concurrent immunosuppressive drugs
• •No concurrent chronic anticoagulation therapy