A Randomized Phase III Trial of Concurrent Biochemotherapy With Cisplatin, Vinblastine, Dacarbazine, IL-2 and Interferon A-2B Versus Cisplatin, Vinblastine, Dacarbazine Alone in Patients With Metastatic Malignant Melanoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed surgically incurable metastatic malignant melanoma

- Measurable disease

- No active brain metastases or edema

- No leptomeningeal disease

- No ocular melanoma

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

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

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

- Hemoglobin at least 9 g/dL

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- SGOT less than 3 times the upper limit of normal unless due to liver metastases

Renal:

- Creatinine less than 1.5 mg/dL OR

- Creatinine clearance at least 75 mL/min

Cardiovascular:

- No congestive heart failure

- No symptoms of coronary artery disease

- No serious cardiac arrhythmias

- No prior myocardial infarction on EKG

- Normal cardiac stress test required for the following:

- Over 50 years of age

- Abnormal EKG

- Prior history of cardiac disease

Pulmonary:

- No symptomatic pulmonary disease

- FEV1 greater than 2.0 L OR at least 75% predicted if over 50 years of age or with
history of pulmonary symptoms

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No significant infection

- HIV negative

- No other prior malignancy within the past 5 years except basal cell or squamous cell
skin cancer or carcinoma in situ of the cervix

- No organ allografts

- No significant disease other than malignancy

- No seizure disorder

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior interleukin-2 therapy for metastatic disease

- At least 4 weeks since prior vaccine therapy

- At least 4 weeks since prior adjuvant immunotherapy

Chemotherapy:

- No prior chemotherapy for disease

Endocrine therapy:

- No concurrent corticosteroids

Radiotherapy:

- No prior radiation therapy to measurable disease site unless disease is clearly
progressive

- At least 4 weeks since prior radiation therapy for local control or palliation and
recovered

Surgery:

- Recovered from prior surgery

Other:

- No prior systemic therapy for metastatic disease

- At least 3 months since definitive therapy for brain metastases