0804 GCC: MAGE-A3/HPV 16 Vaccine for Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria

• •1. Age 18 or older
• •2. Biopsy proven progressive, recurrent (post-surgical, radiation therapy, chemotherapy, combination therapy),or metastatic SCC of the head and neck which, in the judgment of the attending physician, is incurable by standard treatment modalities, OR Biopsy proven SCC which the patient is unwilling to have treated with surgery, chemotherapy or radiation therapy
• •3. One or more of the following: -MAGE-A3 positive tumor -HPV 16 positive tumor.
• •4. Laboratory values obtained less than or equal to 30days prior to registration: -Alkaline phosphatase less than or equal to 3x upper normal limit (UNL) -AST less than or equal to 3x UNL -Creatinine less than or equal to 1.5 x UNL -Hemoglobin greater than or equal to 9.0 g/dL -Albumin greater than or equal to 3 mg/dL
• •5. The subject must be capable of understanding the investigational nature, potential risks and benefits of the study and capable of providing valid informed consent.
• •6. The subject must be willing to return to the University of Maryland Medical center for treatment and study related follow up procedures including blood and tumor collections and completion of imaging studies as required by the protocol.
• •7. ECOG performance status 0-2.
• •8. Tumor that is biopsy accessible and measurable. This includes, but is not limited to, open biopsy, endoscopic biopsy, image guided biopsy, core biopsy and fine needle aspiration.
• •EXCLUSION
• •1. Any of the following:
• •a. Known HIV infection, b. Other circumstances (i.e. concurrent use of systemic immunosuppressants and immunocompromising condition) that in the opinion of the physician renders the patient a poor candidate for this trial. c. Patients with ANY malignant or metastatic SCC mass or lesion within the Central Nervous System (CNS). (e.g. Intraparenchymal/ Brain, Intracordal / Spinal Canal, Bony masses or lesions with extension into the CNS parenchyma) d. Patients with ANY malignant or metastatic SCC mass or lesion or a volume of a mass or lesion in a location that in the judgment of the investigator may significantly impair the health of or threaten the patients life, should an Inflammatory Response occur.
• •2. Any of the following prior therapies: Chemotherapy less than or equal to 4 weeks prior to registration Immunotherapy less than or equal to 4 weeks prior to registration Biologic therapy less than or equal to 4 weeks prior to registration Radiation therapy less than or equal to 4 weeks prior to registration
• •3. Any of the following: Pregnant women Nursing women unwilling to stop breastfeeding Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], or abstinence, etc.) NOTE:This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.
• •4. Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation).
• •5. Either of the following: Other active cancer requiring therapy to control the disease History of other malignancy (i.e. excluding disease under study) within 3 years Exceptions to the above include: adequately treated basal cell or squamous cell skin cancer, prostate cancer.