Low Dose Decitabine + Interferon Alfa-2b in Advanced Renal Cell Carcinoma
|ClinicalTrials.gov Identifier: NCT00561912|
Recruitment Status : Terminated (Low accrual.)
First Posted : November 21, 2007
Results First Posted : December 26, 2011
Last Update Posted : December 26, 2011
- To determine the progression-free survival (PFS) times for patients with advanced renal cell carcinoma (RCC) treated with decitabine and interferon alfa-2b.
- To determine the toxicity of the combination of decitabine and interferon alfa-2b at the proposed dose and schedule in patients with advanced RCC
- To determine overall response by Response Evaluation Criteria in Solid Tumors (RECIST) criteria for patients with advanced RCC treated with decitabine and interferon alfa-2b.
- To determine the overall survival times for patients with advanced RCC treated with decitabine and interferon.
- To study the effects of decitabine and interferon alfa-2b on DNA methylation and gene expression in patients' tumor and non-tumor tissues and their correlation with clinical outcomes.
- To characterize the modulation of cellular immunity induced by the combination of decitabine and interferon alfa-2b in patients with advanced RCC and to correlate these results with clinical outcomes.
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Drug: Decitabine Drug: Interferon Alfa-2b||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Low Dose Decitabine (5-Aza-Deoxycytidine) With Interferon Alfa-2b in Advanced Renal Cell Carcinoma|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
Experimental: Decitabine + Interferon Alfa-2b
Decitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.
15 mg/m^2 IV Daily over one hour for 5 days
Other Names:Drug: Interferon Alfa-2b
0.5 million Units Subcutaneously Twice Daily Continuously. Interferon Alfa-2b will be added on cycle three, day one.
Other Name: Intron A®
- Progression-free Survival (PFS) Times [ Time Frame: From treatment start or until disease progression or death for any reason, at least 16 weeks ]Progression-free survival (PFS) times for participants with advanced renal cell carcinoma (RCC) treated with decitabine and interferon alfa-2b where PFS is defined as starting from day one of the treatment combination to disease progression or death for any reason, measured in weeks.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00561912
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ana M. Aparicio, MD||M.D. Anderson Cancer Center|