Radiotherapy, Cetuximab, and Injections of TNFerade™ Biologic for Elderly or Frail Patients With Head and Neck Cancer

Inclusion Criteria

• •Age 70 or older with an ECOG performance status 0-2,or
• •Patients \> 18 years of age with ECOG performance status of 2 or greater, or
• •Patients \> 18 years of age unsuitable for concurrent chemotherapy or surgery due to:
• •Renal failure, or
• •Severe cardiopulmonary disease, or
• •Other end-organ dysfunction that precludes the use of chemotherapy but does not preclude the administration of TNFerade™ Biologic or cetuximab
• •Tumor that is unresectable or inoperable and not amenable to regular concurrent chemoradiotherapy
• •Patients \> 18 years of age with intermediate stage disease, stages II-III (T2-T3, N0-1MO) carcinoma of the head and neck, including oral cavity, pharynx larynx, paranasal sinuses and cervical esophagus. Selected patients with stage IV disease (T4N0-1M0) will also be considered for enrollment. Therapy is given with curative intent.
• •Disease should be clinically accessible (measurable or evaluable) to keep injection via direct intratumoral injection
• •Informed consent