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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: Completed Phase 1 study, sponsored by University of Washington.
NCT00436254 is a Phase 1 study that has completed, run by University of Washington. The registered enrollment target is 66 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2001-10 |
| Est. Completion | 2025-04-01 |
| Phase | Phase 1 |
What the finished NCT00436254 record still lists
NCT00436254 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher).
The record links to 0 conditions, and to 5 interventions - of which flow cytometry is the first listed.
NCT00436254 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00436254's enrollment target sits among peer trials
66 786th of 2000 higher than 1,203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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