High-Dose Interferon Alfa in Treating Patients With Stage II or StageIII Melanoma

Inclusion Criteria

• •Histologically confirmed primary melanoma of cutaneous origin
• •Stage II (T3 N0 M0 1.5-4.0mm Breslow depth
• •Clinically negative regional lymph node pathologic status unkown OR
• •Histologically negative regional lymph nodes
• •Stage III (T4 N0 M0)
• •Greater than 4.0mm Breslow depth OR
• •Stage III (T1-4 N1)
• •One lymph node positive microscopically
• •Patients must meet at least 1 of the following criteria
• •T2b N0 primary melanoma 1.01-2.0mm with ulceration, node negative
• •T3a-b N0 primary melanoma 2.01-4.0mm with and without ulceration, node negative
• •T4a-b N0 primary melanoma \> 4.0mm with and without ulceration, node negative
• •T1aN1a-2a (microscopic)-primary melanoma of any thickness with microscopically positive lymph node (any number)
• •Note EORTC patients who are node negative T2 or T3 are ineligible
• •Patients with positive sentinel node should undergo complete lymphadenectomy of the nodal basin prior to study
• •Must complete all primary therapy (wide excision with or without lymphadenectomy) and be randomized in the study within 84 days of wide excision
• •No clinical, radiological/laboratory, or pathological evidence of incompletely resected melanoma or any distant metastatic disease
• •No clinically palpable lymphadenopathy
• •Age:
• •18 and over
• •Performance Status:
• •ECOG 0-1
• •Life expectancy:
• •Not specified Hematopoietic
• •WBC at least 3,000/mm\^3
• •Platelet count at least 125,000/mm\^3
• •Hematocrit at least 30%
• •Hepatic:
• •Bilirubin no greater than 2 times the upper limit of normal (ULN)
• •AST, LDH, and Alkaline phosphate no greater than 2 times ULN
• •If lactate dehydrogenase or alkaline phosphate is above normal, a contrast enhanced CT scan or MRI of the liver is required to document the absence of tumor
• •Renal:
• •BUN no greater than 33mg/dl OR
• •Creatinine no greater than 1.8mg/dl
• •Cardiovascular:
• •No history of active ischemic heart disease
• •No cerebrovascular disease
• •No congestive heart failure(New York Heart Association class III or IV heart disease)