An interventional study of HER-2/neu intracellular domain protein and flow cytometry in Breast Cancer, sponsored by University of Washington. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-05.
Sponsored by University of Washington · Not applicable, Interventional, and Diagnostic
RATIONALE: Studying the immune response to a vaccine made from HER2/neu protein may help doctors plan better treatment for patients with breast cancer that overexpresses HER2.
PURPOSE: This clinical trial is studying the immune response in patients who have undergone vaccine therapy for stage III or stage IV breast cancer that overexpresses HER2.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label study.
Patients receive HER2 intracellular domain (ICD) protein mixture intradermally and sterile water injected intradermally (as a negative control) at 6 months post-vaccination with pNGVL3-hICD vaccine. Vital signs and injection site will be monitored prior to skin test and at 60 minutes post-test. Patients return 48-72 hours after skin test for delayed-type hypersensitivity (DTH) measurements. The injection site is biopsied and examined by immunohistochemistry for infiltrating T-cell and antigen-presenting cell populations.
Blood is drawn at 3, 6, and 12 months post-vaccination for assessment of immune memory response. Blood draws are coordinated with parent study. Blood samples are examined by flow cytometry for the presence of memory markers including L-selectin, CD45 isoforms, cytokines, and CCR7.
PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 56 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of stage III/IV breast cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
300mcg (100mcg/peptide) of the HER2 ICD peptide mixture per skin test. This will be injected intradermally on the back at 6 months post active immunization.
This is a laboratory test used to assess the antigen specific T cell population.
This is a laboratory test used to identify CD3+, CD4+, CD45R0+, CD8+, and DC1a+ present in the skin biopsy.
A 3mm punch biopsy is taken of the vaccine site. This is taken for laboratory analysis for immunohistochemical staining.
100mcg of sterile water will be administered intradermally on the back and serves as a negative control for the laboratory analysis. This will be injected intradermally on the back at 6 months post active immunization.
Immunologic memory response to HER-2/neu (HER2) intracellular domain protein
Time frame: 6 months after active immunization
Characterization of memory T-cell population by intracellular cytokine staining
Time frame: 3, 6, and 12 months after active immunization
Quantitate memory precursor frequency by intracellular cytokine staining
Time frame: 3, 6, and 12 months after active immunization
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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University of Washington