Safety Study of Attenuated Vaccinia Virus (GL-ONC1)With Combination Therapy in Head & Neck Cancer

Exclusion Criteria

• •Clinical, radiographic, or pathologic evidence of distant metastatic disease.
• •Patients with fever, active immunosuppressive systemic infection or a suppressed immune system, including AIDS or HIV positivity and known hepatitis infections (HCV or HBC. Eligible patients must have an HIV test conducted within 4 weeks prior to study enrollment with a negative test result.
• •Any form of prior anti-cancer treatment.
• •Disease-related surgery, excluding biopsy.
• •Patients with CNS (Central Nervous System) tumors.
• •Any other open wounds.
• •Concurrent small pox vaccination for 4 weeks before study therapy and during study treatment.
• •Patients on immunosuppressive therapy or with immune system disorders, including autoimmune diseases.
• •Prior splenectomy.
• •Previous organ transplantation.
• •Patients with clinically significant dermatological disorders, as judged by the clinical investigator (e.g., eczema or psoriasis), any skin lesions or ulcers, any history of atopic dermatitis, or any history of Darier's disease (Keratosis Follicularis).
• •Clinically significant cardiac disease (New York Heart Association: Class III or IV).
• •Dementia or altered mental status that would prohibit informed consent.
• •Known allergy to ovalbumin or egg products.
• •Prior gene therapy treatments or prior therapy with cytolytic virus of any type.