A Phase 1 interventional study of pNGVL3-hICD vaccine and sargramostim in HER2-positive Breast Cancer, Stage III Ovarian Epithelial Cancer and Stage III Ovarian Germ Cell Tumor, sponsored by University of Washington. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by University of Washington · Phase 1, Interventional, and Treatment
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.
PRIMARY OBJECTIVES: I. To determine the safety of intradermal administration of 3 doses of a plasmid-based DNA vaccine encoding the ICD of HER2 administered with a fixed dose of GM-CSF. II. To determine whether a plasmid DNA vaccine encoding the ICD of HER2 can elicit HER2 specific immune responses. SECONDARY OBJECTIVES: I. To determine if the dose of the plasmid-based DNA vaccine effects immunologic responses. II. To determine the persistence of DNA at the site of vaccination. OUTLINE: This is a dose-escalation study of a plasmid-based DNA (pNGVL3-hICD) vaccine. Patients receive pNGVL3-hICD vaccine admixed with GM-CSF intradermally once a month for 3 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically for up to 15 years with primary physicians.
Exclusion Criteria:
Patients receive pNGVL3-hICD vaccine admixed with GM-CSF intradermally once a month for 3 months in the absence of disease progression or unacceptable toxicity.
Biological: pNGVL3-hICD vaccine · Biological: sargramostim · Other: flow cytometry · Other: immunologic technique · Other: immunoenzyme technique · Genetic: protein expression analysis · Procedure: biopsy
Plasmid-based DNA vaccine, given intradermally
Given intradermally
Also known as: GM-CSF, granulocyte macrophage colony-stimulating factor, Leukine, Prokine, rhu GM-CFS
Correlative studies
Correlative studies
Also known as: immunological laboratory methods, laboratory methods, immunological
Undergo ELIspot (correlative studies)
Also known as: immunoenzyme techniques
Undergo ELISA (correlative studies)
Undergo punch biopsy (correlative studies)
Also known as: biopsies
Safety as measured by NCI CTCAE v 3.0
Time frame: From baseline
Immune response
Time frame: From baseline
Impact of dose on immunologic response
Time frame: From baseline to month 15
Persistence of DNA at the injection site
Time frame: At 1 and 6 months after last vaccination
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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University of Washington