Immune Response in Patients Who Have Undergone Vaccine Therapy for Stage III or Stage IV Breast Cancer That Overexpresses HER2
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|ClinicalTrials.gov Identifier: NCT00363012|
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : April 5, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: HER-2/neu intracellular domain protein Other: flow cytometry Other: immunohistochemistry staining method Procedure: biopsy Other: Sterile water placement||Not Applicable|
- Determine whether immunologic memory to the HER-2/neu (HER2) intracellular domain (ICD) protein has been generated by active immunization with a HER2 ICD plasmid-based vaccine by assessing the delayed-type hypersensitivity response to HER2 ICD peptides 6 months after vaccination in patients with HER2-overexpressing stage III or IV breast cancer.
- Characterize the memory T-cell population and quantitate memory precursor frequency at 3, 6, and 12 months after active immunization using intracellular cytokine staining.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development of HER-2/Neu (HER2) ICD Memory Immunity After Vaccination With a Plasmid Encoding HER2 ICD in Patients With Advanced Stage HER2 Overexpressing Breast and Ovarian Cancers|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
- Biological: HER-2/neu intracellular domain protein
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.
- Other: flow cytometry
This is a laboratory test used to assess the antigen specific T cell population.
- Other: immunohistochemistry staining method
This is a laboratory test used to identify CD3+, CD4+, CD45R0+, CD8+, and DC1a+ present in the skin biopsy.
- Procedure: biopsy
A 3mm punch biopsy is taken of the vaccine site. This is taken for laboratory analysis for immunohistochemical staining.
- Other: Sterile water placement
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00363012
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109-1024|
|Tumor Vaccine Group at the University of Washington|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Lupe G. Salazar, MD||Tumor Vaccine Group at the University of Washington|