Immune Response in Patients Who Have Undergone Vaccine Therapy for Stage III or Stage IV Breast Cancer That Overexpresses HER2
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.
|Breast Cancer||Biological: HER-2/neu intracellular domain protein Other: flow cytometry Other: immunohistochemistry staining method Procedure: biopsy Other: Sterile water placement|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
|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|
- 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 ]
|Study Start Date:||April 2006|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Biological: HER-2/neu intracellular domain protein
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|