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Trial record 23 of 1270 for:    IFNA2

Low Dose Decitabine + Interferon Alfa-2b in Advanced Renal Cell Carcinoma

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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
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Renal Cell Carcinoma
Interventions Drug: Decitabine
Drug: Interferon Alfa-2b
Enrollment 2
Recruitment Details There were 2 patients registered to the trial between the dates 31 October 2007 and 29 July 2008.
Pre-assignment Details The trial was terminated early due to slow accrual and unavailable treatment agent.
Arm/Group Title Decitabine + Interferon Alfa-2b
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 2
Completed 1
Not Completed 1
Reason Not Completed
ineligible             1
Arm/Group Title Decitabine + Interferon Alfa-2b
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants
53
(47 to 58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
0
   0.0%
Male
2
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Progression-free Survival (PFS) Times
Hide Description 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.
Time Frame From treatment start or until disease progression or death for any reason, at least 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
With one of the two participants ruled ineligible and inevaluable, there was insufficient data for statistical evaluation.
Arm/Group Title Decitabine + Interferon Alfa-2b
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Decitabine + Interferon Alfa-2b
Hide Arm/Group Description 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.
All-Cause Mortality
Decitabine + Interferon Alfa-2b
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Decitabine + Interferon Alfa-2b
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Decitabine + Interferon Alfa-2b
Affected / at Risk (%)
Total   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Ana M. Aparicio, MD / Assistant Professor
Organization: UT MD Anderson Cancer Center
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00561912     History of Changes
Other Study ID Numbers: 2006-0962
First Submitted: November 20, 2007
First Posted: November 21, 2007
Results First Submitted: November 22, 2011
Results First Posted: December 26, 2011
Last Update Posted: December 26, 2011