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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA015704 | U.S. NIH Grant/Contract | View source | |
| K23CA100691 | U.S. NIH Grant/Contract | View source | |
| UWCC-6271 | |||
| UWCC-03-6843-D03 | |||
| UWCC-117 | |||
| FHCRC-6271 | |||
| CDR0000492707 | Registry Identifier | PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HER-2/neu intracellular domain protein | Biological | 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. | ||
| flow cytometry | Other | This is a laboratory test used to assess the antigen specific T cell population. | ||
| immunohistochemistry staining method | Other | This is a laboratory test used to identify CD3+, CD4+, CD45R0+, CD8+, and DC1a+ present in the skin biopsy. | ||
| biopsy | Procedure | A 3mm punch biopsy is taken of the vaccine site. This is taken for laboratory analysis for immunohistochemical staining. | ||
| Sterile water placement | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunologic memory response to HER-2/neu (HER2) intracellular domain protein | 6 months after active immunization |
| Measure | Description | Time Frame |
|---|---|---|
| Characterization of memory T-cell population by intracellular cytokine staining | 3, 6, and 12 months after active immunization | |
| Quantitate memory precursor frequency by intracellular cytokine staining | 3, 6, and 12 months after active immunization |
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DISEASE CHARACTERISTICS:
Diagnosis of stage III/IV breast cancer
Successful completion of HER-2/neu (HER2) intracellular domain (ICD) plasmid-based vaccine trial (Protocol 01-9773-D06: "A Phase I Safety and Efficacy Trial of a DNA Plasmid Based Vaccine Encoding the HER-2/neu Intracellular Domain In Subjects With HER-2/neu-Overexpressing Tumors") within the past 3 months
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Lupe G. Salazar, MD | Tumor Vaccine Group at the University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109-1024 | United States | ||
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| Tumor Vaccine Group at the University of Washington |
| Seattle |
| Washington |
| 98109 |
| United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018567 | Breast Neoplasms, Male |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D005434 | Flow Cytometry |
| D007150 | Immunohistochemistry |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003592 | Cytophotometry |
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D006651 | Histocytochemistry |
| D006652 | Histological Techniques |
| D007158 | Immunologic Techniques |
| D003581 | Cytodiagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
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