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NCT00400517 · ClinicalTrials.gov registry record · Phase 2
GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer
A Phase 2 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
NCT00400517: Completed Phase 2 study, sponsored by The Cleveland Clinic.
NCT00400517 is a Phase 2 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00400517, a Phase 2 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
Study Summary
RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Thalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving GM-CSF and thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving GM-CSF together with thalidomide works in treating patients undergoing surgery for high-risk prostate cancer.
Primary Outcome
Pathologic Complete Response is defined as complete eradication of tumor.
Interventions
- PROCEDURE conventional surgery
- BIOLOGICAL sargramostim
- DRUG thalidomide
- PROCEDURE neoadjuvant therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2003-03 |
| Est. Completion | 2008-06 |
| Phase | Phase 2 |
What the finished NCT00400517 record still lists
NCT00400517 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 4 interventions - of which conventional surgery is the first listed.
NCT00400517 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00400517 about?
NCT00400517 is a clinical study titled "GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer". RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Thalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving GM-CSF and thalidomide before surgery may make the tumor smaller and re...
What is the current status of trial NCT00400517?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2003-03. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00400517?
The interventions under investigation include: conventional surgery (PROCEDURE), sargramostim (BIOLOGICAL), thalidomide (DRUG), neoadjuvant therapy (PROCEDURE).
Who is sponsoring clinical trial NCT00400517?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00400517's enrollment target sits among peer trials
28 1677th of 2000 higher than 304 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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