Parallel Phase I/II Trial of Decitabine and Peg-Interferon in Melanoma
The goal of the first phase of this clinical research study is to find the highest tolerable dose of decitabine and peginterferon alfa-2b that can be given in combination to patients with melanoma. The safety of this drug combination will also be studied.
The goals of the second phase are to learn if decitabine and peginterferon alfa-2b combined can help to control melanoma, and to find out which doses are more effective and/or better tolerated.
Drug: Pegylated Interferon Alpha-2b
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Parallel Phase I/II Study of Low Dose Decitabine (5-Aza-Deoxycytidine) With Peginterferon Alfa-2b in Advanced Melanoma|
- Phase I: Maximum Tolerated Dose [ Time Frame: Continuous reassessment, toxicity dose level assessed with dose levels/28 day cycle ] [ Designated as safety issue: Yes ]
- Phase II: Patient Response <complete response (CR), partial response (PR), or stable disease (SD)> [ Time Frame: Efficacy (response) assessed over a 12 week period ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: Decitabine + Peginterferon Alfa-2b
Decitabine starting dose of 10mg/m^2 given daily via intravenous infusion on days 1-5 of 28 day cycle. Peginterferon Alfa-2b starting dose of 3 µg/kg injection under the skin once a week on days 1, 8, 15, and 21 of 28 day cycle.
Starting dose of 10mg/m^2 given daily via intravenous infusion on days 1-5 of 28 day cycle.
Other Names:Drug: Pegylated Interferon Alpha-2b
Starting dose of 3 µg/kg injection under the skin once a week on days 1, 8, 15, and 21 of 28 day cycle.
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|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Wen-Jen Hwu, MD, PhD||UT MD Anderson Cancer Center|