Phase III Randomized Study of Four Weeks of High Dose Interferon Alfa-2b in Stage TN ,TN, TN, and T, N (Microscopic) Melanoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed primary melanoma of cutaneous origin

- Stage II (T3 N0 M0 1.5-4.0 mm Breslow depth)

- Clinically negative regional lymph node pathologic status unknown OR

- Histologically negative regional lymph nodes

- Stage III (T4 N0 M0)

- Greater than 4.0 mm Breslow depth OR

- Stage III (T1-4 N1)

- One lymph node positive microscopically

- Patients must meet at least 1 of the following criteria:

- T_2b N_0 - primary melanoma 1.01-2.0 mm with ulceration, node negative

- T_3a-b N_0 - primary melanoma 2.01-4.0 mm with and without ulceration, node
negative

- T_4a-b N_0 - primary melanoma > 4.0 mm with or without ulceration, node negative

- T_1-a N_1a-2a (microscopic) - primary melanoma of any thickness with
microscopically positive lymph node (any number)

- Patients with a 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 this study within 84 days of wide excision

- Must have undergone an adequate wide excision of the primary lesion

- No clinical, radiological/laboratory, or pathological evidence of incompletely
resected melanoma or any distant metastatic disease

- No clinically palpable lymphadenopathy

PATIENT CHARACTERISTICS:

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 upper limit of normal (ULN)

- AST, LDH, and alkaline phosphatase no greater than 2 times ULN

- If lactate dehydrogenase or alkaline phosphatase 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 33 mg/dL OR

- Creatinine no greater than 1.8 mg/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)

Other:

- No other history of invasive melanoma

- No autoimmune disorders or conditions of immunosuppression

- No other concurrent or prior malignancies within the past 5 years except:

- Cancer in situ

- Lobular carcinoma in situ of the breast

- Carcinoma in situ of the cervix

- Atypical melanocytic hyperplasia or Clark 1 melanoma in situ

- Basal or squamous cell skin cancer

- No evidence of organic brain syndrome or significant impairment of basal cognitive
function or any psychiatric disorder that would preclude study participation

- No other significant medical or surgical condition, or any medication or treatment
regimens, that would interfere with study participation

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior immunotherapy including tumor vaccines, interferon, interleukins,
levamisole, or other biologic response modifiers for melanoma

Chemotherapy:

- No prior or concurrent chemotherapy

Endocrine therapy:

- No concurrent systemic corticosteroids including oral steroids (i.e., prednisone,
dexamethasone), topical steroid creams or ointments, or any steroid-containing
inhalers

Radiotherapy:

- No prior or concurrent radiotherapy

Surgery:

- See Disease Characteristics

Other:

- No other concurrent immunosuppressive medications