A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion With Melphalan, Tumor Necrosis Factor, and Interferon-Gamma in Patients With Locally Advanced Extremity Melanoma

You may be eligible if

• DISEASE CHARACTERISTICS:
• Biopsy-proven Stage IIIA or IIIAB melanoma (M.D. Anderson staging system) of an extremity, as follows:
• Advanced local disease indicated by 2 or more satellite or in-transit metastases.
• Lower limb regional metastases must be distal to the apex of the femoral triangle except inguinal lymph node metastases.
• Upper limb regional metastases must be distal to the deltoid insertion except axillary lymph node metastases.
• No evidence of systemic disease outside the involved extremity.
• Recurrent disease subsequent to prior successful limb perfusion allowed.
• Bidimensional directly measurable dermal or subcutaneous lesion required.
• PRIOR/CONCURRENT THERAPY:
• No prior isolated limb perfusion.
• Biologic Therapy: At least 1 month since Biologic Therapy.
• At least 3 months since regional therapy of the extremity.
• Chemotherapy: At least 1 month since chemotherap.y
• At least 3 months since regional therapy of the extremity.
• Endocrine Therapy: Not specified.
• Radiotherapy: At least 1 month since radiotherapy.
• Surgery: Not specified.
• PATIENT CHARACTERISTICS:
• Age: 18 and over.
• Performance status: ECOG 0 or 1.
• Hematopoietic: Platelets greater than 150,000.
• Hepatic: Bilirubin less than 1.5 mg/dl; Coagulation profile normal.
• Renal: Creatinine less than 2.0 mg/dl.
• Cardiovascular: No evidence of peripheral vascular disease, e.g.:
• No history of claudication.
• OTHER:
• HIV negative.
• No pregnant or nursing women.