A Multi-Center, Open-Label, Multiple Administration, Rising Dose Study of the Safety, Tolerability, and Efficacy of IL-12 Gene Medicine in Patients With Unresectable or Recurrent/Refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven unresectable, recurrent, or refractory
squamous cell carcinoma of the head and neck Primarily stage III or IV Tumor accessible to
direct injection No tumor involving major blood vessels or obstructing airway

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at
least 50,000/mm3 Hepatic: No prior or concurrent active liver disease SGOT and SGPT no
greater than 3 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5
times ULN Cardiovascular: No New York Heart Association class III or IV heart disease
Pulmonary: No respiratory disease that sufficiently influences oxygenation of arterial
blood Other: At least 2 weeks since prior infection No concurrent infection No active or
clinically relevant viral illness No other malignancies requiring treatment during this
study No prior autoimmune disease (e.g., rheumatic disease, Crohn's disease) No allergy to
polyvinylpyrrolidone (PVP) or related products No prior psychiatric disability No prior
seizures Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior viral based gene therapy, recombinant
DNA products, or bacterial plasmids Chemotherapy: At least 28 days since prior
chemotherapy No concurrent chemotherapy No chemotherapy during follow up period Endocrine
therapy: No concurrent corticosteroids Radiotherapy: At least 28 days since prior
radiotherapy No concurrent radiotherapy No radiotherapy during follow up period Surgery:
At least 28 days since prior surgery No concurrent surgery No surgery during follow up
period Other: At least 30 days since prior investigational drugs No concurrent high dose
nonsteroidal antiinflammatory drugs No concurrent immunosuppressive drugs