Phase III Trial of High Dose Interferon Alfa 2-b Versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients With High Risk Melanoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically proven melanoma of cutaneous origin or from unknown primary at initial
presentation of primary or first clinically detected nodal or satellite/in-transit
recurrence

- No distant metastases

- No melanoma of ocular, mucosal, or other non-cutaneous origin

- One of the following criteria must apply for patients with newly diagnosed melanoma
OR a previously diagnosed primary with current subsequent, clinical, regional nodal
disease and/or satellite/in-transit disease:

- Ulcerated primary melanoma with 1 or more involved lymph nodes (micro/occult or
macro/clinically overt)

- Non-ulcerated or unknown primary melanoma with one macro/clinically overt lymph
node metastasis, including a single matted nodal mass

- No non-ulcerated or unknown primary tumor and a single micrometastatic
lymph node

- Non-ulcerated melanoma with two or more lymph node metastases (micro/occult or
macro/clinically overt) and/or matted nodes

- Any satellite/in transit metastasis with or without lymph node involvement

- Patients with recurrent disease must have recurrent disease in the regional nodal
basin of a prior complete lymphadenectomy

- Multiple regional nodal basin involvement allowed if they are appropriate anatomic
drainage basins for primary site

- Patients must be disease free at time of enrollment based on the following surgical
criteria:

- Patients at initial presentation of melanoma must undergo adequate wide excision
of primary lesion

- Patients with previously diagnosed melanoma must have all disease resected with
pathologically negative margins and no disease at primary site or second
resection of primary

- Full lymphadenectomy required of all patients including those with positive
sentinel nodes or positive satellite/in-transit metastasis

- No more than 56 days since prior lymphadenectomy OR surgery to remove recurrent
disease after prior complete lymphadenectomy

- Must be willing to participate in minimal residual disease studies if registered on
the study on 3/1/2003 or later

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT or SGPT no greater than 2 times ULN

- LDH and alkaline phosphatase no greater than 2 times ULN (above normal value requires
a contrast-enhanced CT scan or MRI of liver)

- No known recent hepatitis positivity by PCR

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 75 mL/min

Cardiovascular:

- No congestive heart failure

- No coronary artery disease

- No serious cardiac arrhythmia

- No prior myocardial infarction

- Normal cardiac stress test required if any of the following are present:

- Over age 50

- Abnormal EKG

- History of cardiac disease

Pulmonary:

- No symptomatic pulmonary disease

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No autoimmune disorders or conditions of immunosuppression

- No other prior malignancy within the past 5 years except the following:

- Adequately treated basal cell or squamous cell skin cancer

- Carcinoma in situ of the cervix

- Adequately treated stage I or II cancer in remission

- HIV negative

- No known AIDS or HIV-1 associated complex

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior immunotherapy, including interferon, interleukin, levamisole, or other
biologic response modifiers

- No other concurrent biologic therapy

Chemotherapy:

- No prior chemotherapy (including infusion or perfusion therapy)

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent systemic corticosteroids or topical steroid creams

- Concurrent steroid antihistamines allowed if no alternative

- No concurrent hormonal therapy

Radiotherapy:

- No prior radiotherapy

- Prior postlumpectomy radiotherapy for breast cancer allowed

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

- No concurrent surgery

Other:

- No concurrent anti-hypertensive medications (arm II only)

- No concurrent immunosuppressive agents

- No other concurrent anticancer therapy

- Antihistamines allowed if no alternative medication suitable