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

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