Clinical trial
Vaccine Therapy With Sargramostim (GM-CSF) in Treating Patients With Her-2…
NCT00436254 · University of Washington, Other · Completed
Key facts
| NCT number | NCT00436254 |
|---|---|
| Title | Vaccine Therapy With Sargramostim (GM-CSF) in Treating Patients With Her-2 Positive Stage III-IV Breast Cancer or Ovarian Cancer |
| Official title | A Phase I Study of a DNA Plasmid Based Vaccine Encoding the HER-2/Neu Intracellular Domain in Subjects With HER-2/Neu (HER2) Overexpressing Tumors |
| Lead sponsor | University of Washington, Other |
| Collaborators | National Cancer Institute (NCI) NIH |
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | HER2-positive Breast Cancer, Stage III Ovarian Epithelial Cancer, Stage III Ovarian Germ Cell Tumor, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer, Stage IV Ovarian Epithelial Cancer, Stage IV Ovarian Germ Cell Tumor |
| Intervention type | Biological, Genetic, Other, Procedure |
| Interventions | pNGVL3-hICD vaccine, sargramostim, flow cytometry, immunologic technique, immunoenzyme technique, protein expression analysis, biopsy |
| Enrollment | 66 |
| Start date | Oct 1, 2001 |
| Primary completion | Mar 1, 2010 |
| Completion | Apr 1, 2025 |
| First posted | Feb 19, 2007 |
| Last update posted | Apr 6, 2025 |
| Countries | United States |
At a glance
- 1–9 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: