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Sponsors and Collaborators: |
University of Virginia National Institutes of Health (NIH) |
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Information provided by: | University of Virginia |
ClinicalTrials.gov Identifier: | NCT00892567 |
The purpose of this study is to evaluate T cell responses against a peptide-based vaccine in patients with breast cancer and to determine whether peptide-specific T cells can be found at the site of breast tumors following vaccination.
Condition | Intervention |
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Breast Neoplasms |
Biological: 9 Peptides from Her-2/neu, CEA, & CTA |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | Evaluation of CD8+ T Cell Activation and Infiltration Into Primary Breast Tumors Following Administration of a Peptide Vaccine |
Estimated Enrollment: | 17 |
Just under 200,000 American women will be diagnosed with breast cancer this year. Standard breast cancer therapies have long included surgical resection, chemotherapy, radiation therapy, and hormonal therapy. However, other immune therapies are now being explored for the treatment of breast cancer, including peptide-based vaccines. In support of directed T cell therapies for breast cancer, antigenic epitopes from breast cancer-associated proteins such as Her-2/neu and the MAGE gene family have been identified, and vaccines containing peptides derived from these proteins have been shown to be safe and immunogenic in breast cancer patients.
Results from successful immune therapy approaches, for various human and murine cancers, have shown that antitumor effects can be mediated by T cells, which is proof-of-principle that the immune system, and in particular, T cells, can reject tumor. Overall, however, the complete clinical response rate for T cell mediated immunotherapies has been low. There are at least two possibilities to explain why this may be the case. First, tumor reactive T cells may not traffic to tumors. Second, tumor reactive T cells may not have adequate effector function within the tumor microenvironment. Neither of these hypotheses has been adequately explored, though there are data suggesting that either or both may represent obstacles to successful immune therapy.
In order to improve upon the clinical response rate with vaccines, we need to address the questions of whether vaccine-induced T cells traffic to tumor and exhibit effector function within the tumor.
Specifically for breast cancer, there are opportunities for targeting T cells against primary tumors with the intent of providing immune protection early in the disease course. In the proposed clinical trial we will be administering a peptide-based vaccine and monitoring responses to the vaccine at the site of primary tumor. Peptide vaccines are unique in that they provide an opportunity to monitor directly the T cell response to defined antigens, enabling dissection of the immune response pre- and post-vaccination. The proposed analyses are designed to test the hypotheses that vaccination 1) enhances T cell infiltration into tumor and 2) induces T cells to become activated and fully differentiate into effector cells. The goals of this proposal are to define the extent to which these two processes occur following vaccination and to identify opportunities for improving tumor targeting and T cell effector function in human breast cancer.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All participants must have:
Laboratory parameters as follows:
Exclusion Criteria:
Participants receiving the following medications or treatments at study registration or within the preceding 30 days are excluded:
Nasonex®).
Participants must not have had prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. Participants with an active autoimmune disorder requiring these therapies are also excluded. The following will not be exclusionary:
Contact: Mary (Jonni) Thoma, BSN | 434-982-6714 | MJH4A@hscmail.mcc.virginia.edu |
Contact: Emily Stell, BA | 434-982-6584 | EMS2B@hscmail.mcc.virginia.edu |
United States, Virginia | |
University of Virginia Health System | |
Charlottesville, Virginia, United States, 22908 |
Principal Investigator: | David R. Brenin, M.D. | University of Virginia |
Responsible Party: | University of Virginia Health System, Department of Surgery ( David R. Brenin, M.D., Assistant Professor of Surgery, Principal Investigator ) |
Study ID Numbers: | 12911, R21 CA130340-01A1 |
Study First Received: | April 30, 2009 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00892567 History of Changes |
Health Authority: | United States: Food and Drug Administration |
breast cancer peptide vaccine immunotherapy |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |