Effect of AdhAQP1 on Salivary Flow in Patients Treated With Radiation for Head and Neck Cancer

Exclusion Criteria

• •1. Pregnant or lactating women. Women of childbearing potential are required to have a negative serum pregnancy test at pre-dose visit 1 and a negative urine pregnancy test within 24 hours of treatment.
• •2. Any experimental therapy within 3 months of planned AdhAQP1 administration (Day 1).
• •3. Any active respiratory tract infection in the 3 weeks prior to planned AdhAQP1 administration (Day 1).
• •4. Active infection that requires the use of intravenous antibiotics and does not resolve at least 1 week before planned AdhAQP1 administration (Day 1).
• •5. Evidence of active substance or alcohol abuse or history of substance or alcohol abuse within two years of pre-dose visit 1.
• •6. Uncontrolled ischemic heart disease: unstable angina, evidence of active ischemic heart disease on ECG, congestive heart failure (left ventricular ejection fraction \< 45% on MUGA or echo) or cardiomyopathy.
• •7. Asthma or chronic obstructive pulmonary disease requiring regular inhaled or systemic corticosteroids.
• •8. Individuals taking prescription medications (anti-cholinergics, anti-depressants) likely to result in salivary hypofunction.
• •9. Individuals with a history of autoimmune diseases affecting salivary glands, including Sj(SqrRoot)(Delta)gren s syndrome, lupus, scleroderma, type 1 diabetes, sarcoidosis, amyloidosis, and chronic graft versus host disease.
• •10. Use of systemic immunosuppressive medications, e.g., corticosteroids. Topical corticosteroids are allowed.
• •11. History of a second malignancy, within the past 3 years, with the exception of adequately treated basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
• •12. Active hepatitis B, hepatitis C or HIV infection tested using blood collected at pre-dose visit 1.
• •13. WBC \<3000/microL or ANC \<1500/microL or Hgb \<10.0 g/dL or platelets \<100,000/microL or absolute lymphocyte count less than or equal to 500/microL using blood collected at pre-dose visit 2.
• •14. ALT and/or AST \> 1.5 times the upper limit of normal (ULN) or alkaline phosphatase \>1.5 times ULN using blood collected at pre-dose visit 2.
• •15. Serum creatinine \> 2 mg/dL using blood collected at pre-dose visit 2.
• •16. Individuals who are active smokers.
• •17. Individuals who consume more than one alcoholic beverage/day.
• •18. Individuals who have an allergy to iodine or shellfish and thus are unable to have sialographic evaluations.
• •19. Individuals whose targeted parotid duct is not clinically accessible on screening sialography evaluations.
• •20. Individuals who on sialography have a distal stenosis in the targeted parotid gland that would impede vector delivery.
• •21. Individuals who likely would require use of a general anesthetic for ultrasound- guided core needle biopsy (applicable only for participants in dose cohorts 2-5).
• •22. Significant concurrent or recently diagnosed (\<2 months from Day 1) medical condition that, in the opinion of the Medically Responsible Investigator, could affect the participant's ability to tolerate or complete the study.
• •23. Live vaccines within 4 weeks of first infusion.
• •24. Previous participation in a rAd5 vector gene transfer study.