Trial Information

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

This study is looking at the safety and tolerability of TNFeradeä Biologic combined with conventional once daily radiation therapy in elderly or frail patients with new onset locally advanced head and neck tumors.

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 certain medical conditions
• carcinoma of the head and neck
• disease should be clinically accessible (measurable or evaluable) to injection via direct intratumoral injection
• normal organ function

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
• 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

If you would like to learn more about participating in this study, please send an e-mail message using the form below.