Gene Therapy in Treating Patients With Unresectable, Recurrent, or Refractory Head and Neck Cancer

Inclusion Criteria: * Females must be non-pregnant and non-lactating and either surgically sterile (via hysterectomy or bilateral tubal ligation), at least one year post-menopausal, or using acceptable methods of contraception for the duration of the study. * Male subjects must be surgically sterile or using an acceptable method of contraception for the duration of the study. * Disease: biopsy-proven unresectable or recurrent/refractory squamoussell\_eareinoma\_of\_the:head-and-neck-(usualLy -Stage-Di-or-IV) - * Tumor accessible to direct injection * Karnofsky performance of at least 70% * Life expectancy of at least three months * Able to give written informed consent Exclusion Criteria: * Infection (concurrent or within previous 2 weeks) * Active or clinically-relevant viral illnesses. * Use of corticosteroids, high-dose non-steroidal antiinflammatory, or immunosuppressive drugs * Chemotherapy, radiotherapy or immunotherapy within 28 days of study entry or during the course of study * Respiratory disease sufficient to influence oxygenation of arterial blood * Active liver disease with transaminases \>3 times the upper limit of normal * Previous history of liver disease * NYHA Class EU or greater heart failure * Serum creatinine of greater than 1.5 times the upper limit of normal * Polymorphonuclear neutrophilic leukocyte count \<3,000/mm3 * Platelet count \<50,000/mm 3 * Tumor involving major blood vessels or obstructing the airway * Previous treatment with viral-based gene therapy, recombinant DNA products, or bacterial plasmids * Use of an investigational drug within 30 days of screening * Other malignancies requiring treatment during the study * Scheduled surgical resection * History of autoimmune disease, including rheumatic disease, Crohn's disease, etc. , * Known allergy to polyvinylpyrrofidone (PVP) or related products * History of psychiatric disabilities or seizures.