Four Doses of MAGE Vaccine for Patients With 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 ≤30days prior to registration:

   • Alkaline phosphatase ≤3 x upper normal limit (UNL)
   • AST ≤3 x UNL
   • Creatinine ≤1.5 x UNL
   • Hemoglobin ≥9.0 g/dL
   • Albumin ≥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. Life expectancy 6 months or greater (in the judgment of the Medical Oncologist/Co-Investigator).
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 Criteria:

1. ECOG performance status 3 or 4.

2. Any of the following:

   • Known HIV infection,
   • 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.
   • 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)
   • 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 patient's life, should an Inflammatory Response occur.

3. Any of the following prior therapies:

   • Chemotherapy < 4 weeks from the date of first vaccination
   • Immunotherapy < 4 weeks from the date of first vaccination
   • Biologic therapy < 4 weeks from the date of first vaccination
   • Radiation therapy < 4 weeks from the date of first vaccination

4. 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.

5. Other concurrent chemotherapy, immunotherapy, radiotherapy, device, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation).

6. Either of the following:

   • Other active cancer requiring therapy to control the disease
   • History of other malignancy (i.e. excluding disease under study) ≤3 years. Exceptions to the above include: adequately treated basal cell or squamous cell skin cancer, prostate cancer.