Interferon Alfa-2b in Treating Patients With Melanoma and Early Lymph Node Metastasis

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed invasive cutaneous melanoma
• * Breslow thickness at least 1.0 mm
• * Primary site must be on head, neck, trunk or extremity
• * No more than 90 days since biopsy
• Protocol A:
• * One or more sentinel lymph nodes with histologic or immunohistochemical evidence of metastatic melanoma
• * Prior regional lymph node dissection
• Protocol B:
• * Sentinel lymph nodes with no histologic or immunohistochemical evidence of metastatic melanoma
• * Sentinel lymph node positive by reverse transcriptase polymerase chain reaction
• No prior wide local excision of the primary tumor with a margin greater than 1.5 cm
• No primary melanoma involving the eye or mucous membranes
• No clinical evidence of satellite lesions or intransit, regional nodal, or distant metastases
• No second primary invasive melanoma
• No prior surgery in the region of the primary draining nodal basin that would disrupt normal lymphatic drainage patterns (e.g., skin grafts, tissue transfers or flaps, or lymph node dissections)
• PATIENT CHARACTERISTICS:
• Age:
• 18 to 70
• Performance status:
• Karnofsky 70-100%
• Life expectancy:
• At least 10 years
• Hematopoietic:
• WBC at least 3,000/mm\^3
• Absolute granulocyte count at least 1,500/mm\^3
• Platelet count at least 70,000/mm\^3
• Hemoglobin at least 10.0 g/dL
• Hepatic:
• Bilirubin less than 2.0 mg/dL
• SGOT/SGPT less than 3 times upper limit of normal (ULN)
• Alkaline phosphatase less than 3 times ULN
• No severe decompensated liver disease (e.g., cirrhosis or autoimmune hepatitis)
• No other significant liver disease that would preclude study participation
• Renal:
• Creatinine normal
• Cardiovascular:
• No cardiovascular disease (e.g., angina or congestive heart failure)
• No myocardial infarction within the past year
• No tachyarrhythmias
• Pulmonary:
• No severe debilitating pulmonary disease (e.g., chronic obstructive pulmonary disease)
• Other:
• No hypersensitivity to interferon alfa-2b or related compounds or any component of the injection
• No major depression or other major psychiatric illness
• No thyroid disorder with thyroid function that is not maintained within the normal range with medications
• No autoimmune disease
• No primary or secondary immunodeficiencies
• No severe diabetes mellitus prone to ketoacidosis
• No significant retinal abnormalities
• No evidence of infection
• No other malignancy within the past 5 years except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I laryngeal cancer
• No other medical condition that would preclude study participation
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after the study
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• No prior immunotherapy
• Chemotherapy:
• No prior chemotherapy
• Endocrine therapy:
• At least 6 months since prior oral or parenteral steroids
• Radiotherapy:
• No prior radiotherapy
• Surgery:
• See Disease Characteristics
• No prior organ transplantation
• Other:
• At least 6 months since prior immunosuppressants
• No concurrent immunosuppressants resulting from prior organ transplantation