Melphalan With or Without Tumor Necrosis Factor in Treating Patients With Locally Advanced Melanoma of the Arm or Leg

Inclusion Criteria

• •Histologically proven locally advanced melanoma of an extremity
• •* One or more evaluable in-transit metastases
• •* All disease within the perfusion field of the extremity (with no local resection options short of amputation)
• •* Disease outside of perfusion field (with no local resection options short of amputation) if all the following are true:
• •* High tumor burden (more than 10 lesions or any single lesion greater than 3 cm)
• •* Presence of pain, edema, skin breakdown, or decreased mobility
• •* Greater than 80% of known tumor is within extremity perfusion field
• •* Life expectancy more than 6 months
• •* No brain metastases
• •At least 1 bidimensionally measurable lesion
• •Patients who received prior prophylactic isolated limb perfusion (ILP) must have 1 of the following:
• •* Disease-free interval for at least 6 months after prior ILP with melphalan
• •* Disease-free interval for at least 3 months after prior ILP with an agent other than melphalan
• •Patients who received prior therapeutic ILP must have 1 of the following:
• •* Partial response of at least 3 months duration after prior ILP with melphalan
• •* Stable response or disease progression after ILP without melphalan (performed at least 3 months prior to study)
• •Performance status - ECOG 0-2
• •Performance status - Zubrod 0-2
• •See Disease Characteristics
• •Platelet count at least 100,000/mm\^3
• •WBC greater than 2,500/mm\^3
• •Hemoglobin greater than 9 g/dL
• •Bilirubin less than 1.25 times ULN
• •AST and ALT less than 2 times ULN
• •Alkaline phosphatase less than 2 times ULN
• •Coagulation studies normal or within 1 second of upper limit of normal (ULN)
• •Creatinine less than 1.5 mg/dL
• •Creatinine clearance greater than 50 mL/min
• •Calcium less than 12 mg/dL
• •No severe peripheral vascular disease (claudication or other ischemic peripheral vascular disease \[e.g., venous thrombosis or occlusive peripheral arterial disease\])
• •No New York Heart Association class II-IV heart disease (congestive heart failure)
• •No uncontrolled or life-threatening cardiac arrhythmia
• •No myocardial infarction within the past year
• •No unstable angina
• •No symptomatic cerebral or carotid artery disease
• •No pulmonary embolism within the past year
• •Other prior malignancy allowed if completed curative therapy, disease-free for at least 5 years, and at low risk for recurrence
• •No active peptic ulcer disease within the past year
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No known melphalan hypersensitivity
• •No known hypersensitivity to any component of tumor necrosis factor alpha formulation
• •No contraindications to ionotropic agents (e.g., dopamine or neosynephrine)
• •No concurrent infections uncontrolled with antibiotics
• •HIV negative
• •At least 1 month since prior biologic therapy
• •See Disease Characteristics
• •At least 1 month since prior chemotherapy
• •At least 4 months since prior isolated limb perfusion
• •At least 1 month since prior radiotherapy
• •See Disease Characteristics
• •At least 12 months since prior coronary artery surgery or angioplasty