A Phase I Study of 5-Azacytidine (Vidaza) With Interferon α2b in Metastatic Melanoma Patients
- 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.
- 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.
Primary Purpose: Treatment
Maximum tolerated dose
Gregory A. Daniels, MD, PhD
University of California, San Diego
United States: Federal Government
|Rebecca and John Moores UCSD Cancer Center||La Jolla, California 92093-0658|