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

This is a Phase I/II trial to study the effectiveness of gene therapy in treating patients
who have 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.