Safety Study of HPV DNA Vaccine to Treat Head and Neck Cancer Patients

Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the
head and neck or unknown primary with level II/III (jugulodigastric) nodal involvement
(which have been found in previous studies to be the result of subclinical
oropharyngeal carcinoma).

2. Head and neck cancer patients documented to have HPV-16 DNA within their tumors as
determined by in situ hybridization are eligible for this study.

3. Fresh-frozen or paraffin-embedded material must be available for in situ hybridization
testing for HPV-16 DNA.

4. Staging criteria established by the American Joint Committee on Clinical Investigation
(AJCC, Fifth Edition, 1997) for Stage III (T1-3N1M0, T3N0M0) or IV (T1-4N2M0, T4N0-1M0
) disease.

5. Age ≥ 18 years

6. Life expectancy of greater than 4 months.

7. Baseline Eastern Cooperative Oncology Group performance status of 0, 1 at the time of
multi-modality treatment administration.

9. Patients must have adequate organ function at the time of enrollment as defined by the
following parameters: white blood cell count > 3,000 lymphocyte number > 500 absolute
neutrophil count > 1,000 platelets > 90,000 hemoglobulin > 9 total bilirubin <3 X the
institutional limit of normal AST(SGOT)/ALT(SGPT) <3 X the institutional limit of normal
creatinine < 2.5X the institutional limit of normal

Exclusion Criteria:

1. Diagnosis of immunosuppression or prolonged, active use of immunosuppressive
medications such as steroids.

2. Prior enrollment in any vaccine study in the past 24 months.

3. Presence of uncontrolled concurrent illness including, but not limited to, ongoing or
active infection, symptomatic congestive heart failure, unstable angina pectoris, or
psychiatric illness/social situations that would limit compliance with study
requirements.

4. Presence or history of autoimmune disease such as multiple sclerosis, exclusive of a
history of thyroiditis, psoriasis, inflammatory bowel disease, or Sjogren's syndrome.

5. Pregnancy or breast feeding. Pregnancy is defined as any female subject of
reproductive potential [defined as girls who have reached menarche or women who have
not been post-menopausal for at least 24 consecutive months, i.e., who have had menses
within the preceding 24 months, or have not undergone surgical sterilization (e.g.,
hysterectomy, bilateral oophorectomy, or bilateral tubal ligation)] must have a
negative serum -hcg test within 3 days prior to study entry.

6. History of prior malignancy permitted if patient has been disease free for ≥ 5 years,
however individuals with completely resected basal cell or squamous cell carcinoma of
the skin within this interval may be enrolled.

7. Inability to understand or unwillingness to sign an informed consent document.

8. Patients with a history of arterial or venous thrombosis.

9. Patients with non-healed wounds.

10. Patients with chronic infection with or a history of Hepatitis B, Hepatitis C, or HIV
infection as determined by serology tests obtained during the eligibility screening.

11. Current use of any electronic stimulation device, such as cardiac demand pacemakers,
automatic implantable cardiac defibrillator, nerve stimulators, or deep brain
stimulators.

12. History of, or documented in an EKG within 30 days of study eligibility screening,
cardiac arrhythmia or palpitations [e.g., supraventricular tachycardia, atrial
fibrillation, frequent ectopy, or sinus bradycardia (i.e., <50 beats per minute on
exam)] prior to study entry.

NOTE: Sinus arrhythmia is not excluded.

13. History of syncope or fainting episode within 1 year of study entry.

14. Seizure disorder or any history of prior seizure.

15. Presence of any surgical or traumatic metal implants at the site of administration
(deltoid muscles).

16. Bleeding disorder or other contraindication for intramuscular injection.

17. A skin-fold measurement of the cutaneous and subcutaneous tissue that exceeds 40mm at
one or more of the eligible injection sites (the medial deltoid muscles).

18. History of axillary lymph node dissection.

19. Patients who have had chemotherapy or radiotherapy within 28 days (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 28 days earlier.