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NCT00561912 · ClinicalTrials.gov registry record · Phase 2
Low Dose Decitabine + Interferon Alfa-2b in Advanced Renal Cell Carcinoma
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT00561912: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00561912 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00561912, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
Primary Objective: * To determine the progression-free survival (PFS) times for patients with advanced renal cell carcinoma (RCC) treated with decitabine and interferon alfa-2b. Secondary Objectives: * 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.
Primary Outcome
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.
Interventions
- DRUG Decitabine
- DRUG Interferon Alfa-2b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-11 |
| Phase | Phase 2 |
Why NCT00561912 stopped before completion
NCT00561912 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Decitabine is the first listed.
NCT00561912 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00561912 about?
NCT00561912 is a clinical study titled "Low Dose Decitabine + Interferon Alfa-2b in Advanced Renal Cell Carcinoma". Primary Objective: * To determine the progression-free survival (PFS) times for patients with advanced renal cell carcinoma (RCC) treated with decitabine and interferon alfa-2b. Secondary Objectives: * To determine the toxicity of the combination of decitabine and interferon alfa-2b at the propos...
What is the current status of trial NCT00561912?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2007-10. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00561912?
The interventions under investigation include: Decitabine (DRUG), Interferon Alfa-2b (DRUG).
Who is sponsoring clinical trial NCT00561912?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00561912's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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