Double Blind Phase III Trial of Effects of Low Dose 13-Cisretinoic Acid on Prevention of Second Primaries in Stages I-II Head and Neck Cancer

Inclusion Criteria: * Informed consent i obtained, the approved form is signed, and on file at the institution. * Histologically confirmed squamous cell carcinoma. * All chest x-rays and cervical spine x-rays done after definitive treatment within 35 days prior to randomization and all hematology andchemistries done within 2 weeks prior to randomization. * The following sites and stages of cancers will be eligible. Oral Cavity 1. T1 NO 2. T2 NO 3.142 Oropharynx <!-- --> 1. T1 NO 2. T2 NO 3.143 Hypopharynx 1\. T1 NO 3.144 Larynx 1. T1 NO 2. T2 NO * Age greater than 18 years. * ECOG performance status 0 or 1. * Patients must have adequate bone marrow, hepatic and renal function defined as follows: WBC \>3,500/mm, Platelets \> 125,000/mm.3 Total Bilirubin \< 2 mg%, Serum creatinine \< 2.5 mg%. Serum SGOT \< 2x normal, Alkaline Phosphatase \< 2x normal. Fasting Serum triglyceride levels \< 210 mg %. Fasting cholesterol \< 350 mg %. Patient may not be under systemic therapy for hyperlipidemia or have symptomatic arteriosclerotic coronary artery disease or have undergone coronary bypass surgery. * The patient must have completed primary treatment of their cancer with surgery and/or radiation therapy within 730 days prior to randomization. * The patient has had surgery and/or radiation therapy as outlined in Sections 5.0 and 6.0, and has been rendered disease-free. * If currently receiving, patient must discontinue mega vitamin doses Exclusion Criteria: * Women of child bearing potential. * Patient with severe coronary artery disease (Class III-IV New York Heart Association.) * Histology other than squamous cell carcinoma. * Distant metastases. * Completion of previous treatment for their primary cancer with radiation, or surgery (except for biopsy) more than 730 days ago. * Prior, synchronous, or concurrent malignancy except basal cell skin cancer. * Failure to be rendered disease-free of primary tumor (includes positive surgical margins). * The patient has had prior therapy other than that outlined in Sections 5.0 and 6.0 of the protocol.