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NCT00585221 · ClinicalTrials.gov registry record · Phase 2
Study of Imatinib and Peginterferon α-2b in Gastrointestinal Stromal Tumor (GIST) Patients
A Phase 2 study, sponsored by University of Utah.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT00585221: Clinical Trial Phase 2 study, sponsored by University of Utah.
NCT00585221 is a Phase 2 study that was terminated before completion, run by University of Utah. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00585221, a Phase 2 study, was terminated before completion, sponsored by University of Utah.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
Imatinib (IM) has dramatically improved survival of gastrointestinal stromal tumors (GIST). However, most patients become resistant to IM in less than two years. This clinical trial combines targeted therapy (IM) with immunotherapy (peginterferon α-2b). Hypothesis: Apoptosis/necrosis of imatinib-sensitive GIST releases GIST-specific antigens in vivo while Peginterferon α-2b fulfills the role of cytokine signal (danger signal), this combination can induce effective innate and adaptive anti-GIST immunity, which can eradicate imatinib-resistant clones and GIST stem cells via recognition of common antigens shared with imatinib-sensitive GIST, leading to improved response rate and remission duration.
Primary Outcome
Response rate is measured by PET-CT scan (a decrease in standardized uptake value (SUV) by 25%), Response Evaluation Criteria in Solid Tumors (RECIST), and Choi criteria (10% decrease in tumor size or a 15% decrease in tumor density on contrast-enhanced CT, computed tomography, scan).
Interventions
- DRUG Imatinib
- DRUG Peginterferon-alpha 2b (PegIFNa2b);
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2007-07 |
| Est. Completion | 2009-07 |
| Phase | Phase 2 |
Why NCT00585221 stopped before completion
NCT00585221 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Imatinib is the first listed.
NCT00585221 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00585221 about?
NCT00585221 is a clinical study titled "Study of Imatinib and Peginterferon α-2b in Gastrointestinal Stromal Tumor (GIST) Patients". Imatinib (IM) has dramatically improved survival of gastrointestinal stromal tumors (GIST). However, most patients become resistant to IM in less than two years. This clinical trial combines targeted therapy (IM) with immunotherapy (peginterferon α-2b). Hypothesis: Apoptosis/necrosis of imatinib-sen...
What is the current status of trial NCT00585221?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2007-07. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00585221?
The interventions under investigation include: Imatinib (DRUG), Peginterferon-alpha 2b (PegIFNa2b); (DRUG).
Who is sponsoring clinical trial NCT00585221?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00585221's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 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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