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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
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.
Details
| Lead sponsor | University of Washington |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 66 |
| Start date | 2001-10 |
| Completion | 2025-04-01 |
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
Interventions
- pNGVL3-hICD vaccine
- sargramostim
- flow cytometry
- immunologic technique
- immunoenzyme technique
- protein expression analysis
- biopsy
Primary outcomes
- Safety as measured by NCI CTCAE v 3.0 — From baseline
- Immune response — From baseline
Countries
United States