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

Exclusion criteria

• History of malignancy in the last 2 years except carcinoma in situ of the cervix or bladder, non-melanomatous skin cancer, or localized early stage prostate cancer, with patients continually disease free, or cancers that are not felt to influence treatment for head and neck cancer and life expectancy of patient
• Overt systemic metastatic disease
• Previous radiation or chemotherapy for malignancy of the head and neck
• Clinical evidence of active infection of any type
• pregnant or lactating women
• Experimental medications within the last 4 weeks prior to Day 1
• Chronic treatment for greater than 6 months with steroids at doses above 10 mg/day prednisone (or equivalent)
• Patients receiving hormone replacement therapy or hormonal contraceptives within 2 weeks of day 1
• Patients who have undergone surgery within the last 1 month
• Allergic reaction to cetuximab