Trial Outcomes & Findings for Low Dose Decitabine + Interferon Alfa-2b in Advanced Renal Cell Carcinoma (NCT NCT00561912)

NCT ID: NCT00561912

Last Updated: 2011-12-26

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: From treatment start or until disease progression or death for any reason, at least 16 weeks
• Results posted on: 2011-12-26

Participant Flow

There were 2 patients registered to the trial between the dates 31 October 2007 and 29 July 2008.

The trial was terminated early due to slow accrual and unavailable treatment agent.

Participant milestones

Measure	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.
Overall Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	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.
Overall Study ineligible	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Decitabine + Interferon Alfa-2b n=2 Participants 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.
Age Continuous	53 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: From treatment start or until disease progression or death for any reason, at least 16 weeks

Population: With one of the two participants ruled ineligible and inevaluable, there was insufficient data for statistical evaluation.

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.

Outcome measures

Outcome data not reported

Adverse Events

Decitabine + Interferon Alfa-2b

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ana M. Aparicio, MD / Assistant Professor

UT MD Anderson Cancer Center

Email: CR_Study_Registration@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place