Phase 2
N=22
Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving Trastuzumab
HER2/Neu Positive · HLA-A2 Positive Cells Present · Stage IV Breast Cancer · Stage IV Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00194714 ↗Enrolled (actual)
22
Serious AEs
14.3%
Results posted
Jun 2022
Primary outcome: Primary: Immune Response Measured by IFN-gamma Secreting PBMC Precursor Frequency by ELIspot and HLA-A2 Major Histocompatibility Complex Tetramer Analysis — 14; 4; 1; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- HER-2/neu Peptide Vaccine (Biological); Laboratory Biomarker Analysis (Other)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- Female
- Sponsor
- University of Washington
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immune Response Measured by IFN-gamma Secreting PBMC Precursor Frequency by ELIspot and HLA-A2 Major Histocompatibility Complex Tetramer Analysis |
14; 4; 1; 16; 3; 0 | — |
| PRIMARY Number of Adverse Events Graded Using National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 |
508; 60; 4; 1 | — |
| SECONDARY Overall Survival |
10; 11 | — |
Summary
This phase I/II trial studies the side effects of vaccine therapy and to see how well it works in treating patients with stage IV major histocompatibility complex, class I, A2 antigen (HLA-A2) and human epidermal growth factor receptor 2 (HER2) positive breast or ovarian cancer who are receiving trastuzumab. Giving booster vaccines made from HER2 peptides may help increase HER2 specific immunity and immune memory cells.
Eligibility Criteria
Inclusion Criteria
- Subjects must have either stage IV breast or ovarian cancer in remission or with stable disease on trastuzumab monotherapy
- HER2 overexpression by immunohistocytochemistry (IHC) of 2+ or 3+, in the primary tumor or metastasis; if overexpression is 2+ by IHC, then patients must have HER2 gene amplification documented by fluorescence in situ hybridization (FISH)
- Subjects must be HLA-A2 positive
- Eligible subjects must have completed appropriate treatment for their primary disease and be off cytotoxic chemotherapy and any immunosuppressive agents such as systemic steroids for at least 30 days prior to enrollment; patients should continue trastuzumab monotherapy throughout the course of this protocol; concurrent hormonal and biphosphonate therapies are allowed
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score = 0 or 1
- Male subjects must agree to contraceptive use during the study period (7 months) and non-menopausal female subjects must agree to contraception for the remainder of their childbearing years
- Hematocrit >= 30 performed within 60 days of enrollment
- Platelet count >= 100, 000 performed within 60 days of enrollment
- White blood cells (WBC) >= 3000/ul performed within 60 days of enrollment
- Stable creatinine = = 60 ml/min performed within 60 days of enrollment
- Serum bilirubin 15% from the original MUGA scan
Exclusion Criteria
- Subjects cannot be simultaneously enrolled on other treatment studies
- Any contraindication to receiving granulocyte-macrophage colony-stimulating factor (GM-CSF) based vaccine products
- Cardiac disease, specifically restrictive cardiomyopathy, unstable angina within the last 6 months prior to enrollment, New York Heart Association functional class III-IV heart failure on active treatment with normalized LVEF on therapy, and symptomatic pericardial effusion
- Active autoimmune disease
- Subjects cannot have an active immunodeficiency disorder, e.g. human immunodeficiency virus (HIV)
Data sourced from ClinicalTrials.gov (NCT00194714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.