OBJECTIVES:
Primary
* Determine the maximum tolerated dose (MTD) of azacitidine in combination with interferon alfa-2b in patients with metastatic melanoma.
* Determine if the MTD of this regimen is biologically active in these patients.
* Define and describe the toxicities associated with this regimen.
Secondary
* Determine, preliminarily, the response in patients treated with this regimen.
* Describe, preliminarily, the time to progression and overall survival of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of azacitidine.
Patients receive azacitidine subcutaneously (SC) once daily on days 1-5 (week 1) followed by interferon alfa-2b SC 3 days a week in weeks 2-4. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of azacitidine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
