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NCT00436254 · ClinicalTrials.gov registry record · Phase 1

Vaccine Therapy With Sargramostim (GM-CSF) in Treating Patients With Her-2 Positive Stage III-IV Breast Cancer or Ovarian Cancer

A Phase 1 study, sponsored by University of Washington.

Completed
Registry status
Phase 1
Development phase
66
Enrollment target

NCT00436254 is a Phase 1 study that has completed, run by University of Washington. The registered enrollment target is 66 participants.

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The verdict

NCT00436254, a Phase 1 study, has completed, sponsored by University of Washington.

COMPLETED
Registry status
Phase 1
Development phase
66 participants
Enrollment target

Study Summary

RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy together with sargramostim may be an effective treatment for breast cancer and ovarian cancer. PURPOSE: This phase I trial is studying the side effects and identifying the best dose of vaccine therapy when given together with sargramostim in treating patients with stage III-IV breast cancer or ovarian cancer.

Interventions

  • OTHER flow cytometry
  • BIOLOGICAL sargramostim
  • OTHER immunoenzyme technique
  • OTHER immunologic technique
  • BIOLOGICAL pNGVL3-hICD vaccine

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2001-10
Est. Completion 2025-04-01
Phase Phase 1

Sponsor

University of Washington

1,048 total trials

What the Registry Record Tells You About NCT00436254

The ClinicalTrials.gov registry entry for NCT00436254 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which flow cytometry is the first listed.

NCT00436254 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00436254 about?

NCT00436254 is a clinical study titled "Vaccine Therapy With Sargramostim (GM-CSF) in Treating Patients With Her-2 Positive Stage III-IV Breast Cancer or Ovarian Cancer". RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy together with sargramostim may be an effective treatment ...

What is the current status of trial NCT00436254?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2001-10. Estimated completion is 2025-04-01.

What interventions are being tested in trial NCT00436254?

The interventions under investigation include: flow cytometry (OTHER), sargramostim (BIOLOGICAL), immunoenzyme technique (OTHER), immunologic technique (OTHER), pNGVL3-hICD vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00436254?

This trial is sponsored by University of Washington, which has 1,048 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.