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.