Parallel Phase I/II Trial of Decitabine and Peg-Interferon in Melanoma: Phase I Portion
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.
|Study Design:||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: Dose-limiting toxicity (DLT) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Dose limiting toxicity defined as any treatment related toxicity that meets one or more of the following criteria:
Any grade 3 or 4 non-hematologic toxicity regardless of duration, except:
- Grade 3 nausea or vomiting occurring without maximal antiemetic therapy.
Grade 3 diarrhea that occurs following without adequate loperamide therapy.
- Grade 4 thrombocytopenia.
- Grade 4 neutropenia lasting > 2 weeks or associated with infection.
- Any toxicity that results in a treatment delay of > 4weeks.
- Phase II: Patient Response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Success defined as either a complete response (CR), a partial response (PR), or stable disease (SD). Target combined endpoint of CR+PR+SD in this trial is 30%. Evaluation of response follows the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines.
|Study Start Date:||September 2008|
|Study Completion Date:||May 2015|
|Primary Completion Date:||May 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00791271
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Wen-Jen Hwu, MD, PhD||M.D. Anderson Cancer Center|