Combination Chemotherapy, Interferon Alfa, and Interleukin-2 in Treating Patients With Metastatic Melanoma

OBJECTIVES:

• Assess the rate of disease stabilization in patients with metastatic melanoma when treated with interferon alfa, dacarbazine, cisplatin, and interleukin-2.
• Assess toxicity, overall response rate, and response duration in these patients when treated with this regimen.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center. Patients are randomized to one of two treatment arms.

• Arm I: Patients receive dacarbazine IV over 1 hour and cisplatin IV over 3 hours on days 1-3. Patients also receive interferon alfa subcutaneously (SQ) on days 1-5 and interleukin-2 by continuous IV infusion on days 4-9. Treatment continues every 28 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients receive dacarbazine IV on day 1 and 22 every 28 days for 2 courses. Patients then receive treatment as in arm I for a maximum of 4 courses.

Patients are followed every 2 months for 6 months, then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 42-90 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed melanoma that is metastatic and unresectable
• Measurable, progressive disease (by physical exam and/or noninvasive imaging)

• No prior irradiation of indicator lesions
• No CNS metastases (confirmed by CT or MRI)

PATIENT CHARACTERISTICS:

Age:

• 18 to 70

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Greater than 3 months

Hematopoietic:

• WBC at least 2,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• No serious hepatic disease

Renal:

• Creatinine no greater than 1.65 mg/dL
• No serious renal disease

Cardiovascular:

• No serious cardiac disease

Pulmonary:

• No serious pulmonary disease

Other:

• No organ allograft
• No autoimmune disease
• No uncontrolled infection
• No active peptic ulcer
• No hyper or hypothyroidism
• No requirement for corticosteroids
• No second malignancy except basal cell skin carcinoma or carcinoma in situ of the cervix
• Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior immunotherapy with interleukin-2
• No prior interferon alfa in combination with cisplatin or dacarbazine

Chemotherapy:

• No prior chemotherapy with cisplatin in combination with dacarbazine
• More than 3 months since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• Prior radiotherapy allowed

Surgery:

• Not specified