Azacitidine and Recombinant Interferon Alfa-2b in Treating Patients With Stage III or Stage IV Melanoma or Stage IV Kidney Cancer That Cannot Be Removed By Surgery

Inclusion Criteria:

• Histologically confirmed diagnosis of 1 of the following:

  • Melanoma

    • Unresectable stage III disease
    • Stage IV disease

  • Renal cell carcinoma

    • Unresectable and/or stage IV disease
• Measurable disease

• No untreated brain metastases or leptomeningeal disease

  • Patients with previously treated brain metastases are eligible provided they have no evidence of progression for ≥ 4 weeks following treatment and do not require steroids
• Performance status - ECOG 0-2
• Performance status - Karnofsky 60-100%
• More than 3 months
• WBC ≥ 3,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9.0 g/dL (may be transfused to this level)
• PT or PTT < 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 2.0 mg/mL
• AST and ALT ≤ 3 times ULN (5 times ULN for patients with liver metastases)
• Albumin ≥ 3.0 g/dL
• Creatinine ≤ 1.7 mg/dL
• Creatinine clearance ≥ 50 mL/min
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No ventricular cardiac arrhythmia
• No myocardial infarction within the past 3 months
• No dyspnea at rest
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No active gastrointestinal bleeding or ulcer disease
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• No other uncontrolled illness
• No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study agents
• At least 2 weeks since prior immunotherapy
• Prior adjuvant interferon alfa for metastatic disease or in the adjuvant setting allowed
• At least 3 weeks since prior cytotoxic agents (6 weeks for nitrosoureas or mitomycin)
• See Disease Characteristics
• At least 2 weeks since prior hormonal therapy
• At least 1 week since prior and no concurrent steroids
• At least 3 weeks since prior radiotherapy
• At least 2 weeks since prior minor surgery
• At least 3 weeks since prior major surgery
• Recovered from all prior therapy
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent investigational agents
• No other concurrent anticancer therapy