This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Squamous Cell Carcinoma of the Head and Neck is a devastating illness, the treatment of which is associated with significant attendant morbidity. This type of cancer affects 43,000 individuals each year with an estimated survival rate of 50%. For some patients who develop local or distant metastasis, surgery is a viable therapeutic option. The remainder of individuals are forced to choose between palliative chemotherapy and supportive care. For individuals with recurrent, progressive or metastatic SCCHN, therapeutic options are limited. One potential treatment alternative for this patient population is the use of peptide-based immunotherapy. Recently, several investigators, including us, have identified a high prevalence of specific antigens (MAGE-A3 and HPV 16) on tumors of SCCHN. In order to define the feasibility and safety of these agents, in this clinical trial, we will screen patients for immunologic competence. In registered patients, we will test the ability of these 2 peptides, MAGE-A3 and HPV 16, to stimulate antigen-specific T-cell responses. Successful completion of Phase I of this clinical trial will result in the development of a strong foundation for a Phase II and Phase III clinical trial using these peptides as Immunotherapy for SCCHN. This is a 2-year, Phase I, single-site, dose escalation cohort study. This study is being done to: 1) Test the safety of the investigational cancer vaccine made of MAGE-A3 and HPV 16; 2) Learn what effects good and bad the vaccine will have on patients and their Head and Neck cancer; 3) Determine what doses of the vaccine will best stimulate the patient's immune system; 4) Characterize the efficacy of using MAGE-A3 and HPV 16 peptide vaccines for the treatment of SCCHN by measuring changes in tumor size from Baseline, the number of patients who achieve a response to the drug, to see no further progression of their cancer, and survival. Patients are selected based upon the presence of antigen and HLA-A2 in the subjects' blood and tumor tissue, and additional Inclusion/Exclusion criteria. Patients will then be assigned to one of three Cohorts based on the presence of one or more of the specific antigens. Patients will be treated with combination vaccines once a month for four months, possibly for an additional 4 treatment depending on tumor response to the vaccine. Each treatment and follow-up visits will consist of safety and research blood samples, physical exams, Performance Status and Quality of Life questionnaires, CT/PET scans for tumor measurement, demographic and social habits information, medical and surgical history assessment.
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