Clinical trial NCT00324727 (phase 3, status: completed)
Conditions: intraocular melanoma, melanoma (skin), metastatic cancer
ICD codes: Z96.1, T85.22XS, T85.21XS, T85.22XA, T85.22XD, T85.21XA, T85.21XD, C43.51, C43.9, C43.52, D03.51, C43.8, Z85.820, D03.52, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: melphalan, regional chemotherapy, systemic chemotherapy
SMILES: N[C@@H](CC1=CC=C(C=C1)N(CCCl)CCCl)C(O)=O, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, FC1=CNC(=O)NC1=O
Eligibility criteria:

        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