Active Immunization of Patients With Carcinoma of Oral Cavity or Oropharynx With Autologous Dendritic Cells Transfected With DNA From Autologous Tumor

Inclusion Criteria

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• •Written informed consent conforming to the institutional guidelines obtained from the patient.
• •Documented evidence of oral carcinoma or carcinoma of the oropharynx. Patients will undergo surgery, surgery and radiation or chemoradiation therapy, and will become eligible for the first vaccine between 1and 4 months after termination of conventional therapy.
• •Adequate immune competence, as indicated by positive reaction to one or more of the DTH skin tests.
• •Age 18 or above. Karnofsky performance status \> 70% and life expectancy \> eight months.
• •Adequate hematologic function:
• •Absolute neutrophil count \> 1,000/mm3 Absolute lymphocyte count \> 1,000/mm3 Hemoglobin \> 9 g/dl Platelets \> 100,000/mm3 h) Liver function tests: Bilirubin (total) \< 1.7 mg/dl Alkaline phosphatase \< 78 u/L (2 x ULN) SGOT \< 54 u/L (2 x ULN) Lactic dehydrogenase \< 180 u/L (2 x ULN) i) Kidney profile: Serum electrolytes Sodium 135-145 mEq/L Potassium 3.5-5.0 mEq/L Bicarbonate 21-28 mEq/L Chloride 100-108 mmol/L 2) Serum creatinine \<4.5 mg/dL (3 x ULN) 3) BUN 8-25 mg/dL j) At least four weeks since any prior radiation therapy, immunotherapy, or chemotherapy
• •Evidence of active infection requiring antibiotic therapy. Positive HIV or Hepatitis B or C screen tests Active intracranial metastases. Previously resected intracranial disease and or previously irradiated intracranial metastases which have been stable for four weeks are eligible.
• •History of other concurrent malignancies except basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
• •Pregnant or lactating women. Patients requiring systemic corticosteroids (unless patient has had NO STEROIDS IN THE PAST 4 WEEKS).
• •Autoimmune disease including, but not limited to, rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, or ankylosing spondylitis