Wild Type p53 Adenovirus for Oral Premalignancies

Inclusion Criteria: * Males and females, aged 18 years and older. * Patients must have histologically confirmed diagnosis of mild-moderate dysplasia or severe dysplasia/carcinoma in situ (CIS) of the oral cavity or oral pharynx. * Patients must have clinical evidence of mild to moderate dysplasia or severe dysplasia/CIS of the oral cavity or oral pharynx that is diffuse. * Patients must have diffuse\* premalignant disease of the oral cavity or oral pharynx and must have: a) been previously treated with conventional treatment (e.g.: radiation or surgery) for a prior head \& neck malignancy or b) failed biochemoprevention approaches for premalignant disease or c) failed other therapeutic approaches for premalignant disease. (\*See protocol for definition of diffuse.) * All patients must have a Karnofsky performance status of greater than or equal to 70% (Karnofsky scale, Appendix B). * All patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the institution. * If female and of childbearing potential (non-childbearing defined as 1 year post menopause or surgically sterilized), patients must have a negative serum pregnancy test. Patients (male and female) must agree to use barrier contraception while on study and to avoid pregnancy for 1 year after treatment. * Patients must have negative serology for the Human Immunodeficiency Virus (HIV) Type I. (Safety of the product has not been esta…