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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 is a Phase 2 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 28 participants.

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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.

Interventions

  • PROCEDURE conventional surgery
  • BIOLOGICAL sargramostim
  • DRUG thalidomide
  • PROCEDURE neoadjuvant therapy

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2003-03
Est. Completion 2008-06
Phase Phase 2

Sponsor

The Cleveland Clinic

688 total trials

What the Registry Record Tells You About NCT00400517

The ClinicalTrials.gov registry entry for NCT00400517 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which conventional surgery is the first listed.

NCT00400517 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.