A Multicenter Trial of Adjuvant Interferon Alfa-2b for Melanoma Patients With Early Lymph Node Metastasis Detected by Lymphatic Mapping and Sentinel Lymph Node Biopsy

Date de début de l'étude : 1 octobre 1999

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