Azacitidine and Interferon Alfa in Treating Patients With Metastatic Melanoma
Recruitment status was Active, not recruiting
RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Interferon alfa may interfere with the growth of tumor cells. Giving azacitidine together with interferon alfa may be an effective treatment for melanoma.
PURPOSE: This phase I trial is studying the side effects and best dose of azacitidine when given together with interferon alfa in treating patients with metastatic melanoma.
Biological: recombinant interferon alfa-2b
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of 5-Azacytidine (Vidaza) With Interferon α2b in Metastatic Melanoma Patients|
- Maximum tolerated dose [ Designated as safety issue: Yes ]
- Toxicity [ Designated as safety issue: Yes ]
- Response [ Designated as safety issue: No ]
- Survival at day 1, 12 months, 3 years, and 5 years [ Designated as safety issue: No ]
- Relapse-free survival [ Designated as safety issue: No ]
- Time to relapse [ Designated as safety issue: No ]
|Study Start Date:||February 2006|
|Estimated Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398450
|United States, California|
|Rebecca and John Moores UCSD Cancer Center|
|La Jolla, California, United States, 92093-0658|
|Principal Investigator:||Gregory A. Daniels, MD, PhD||University of California, San Diego|