Phase I Dose Escalating Study of Cetuximab plus EGFR AS DNA for Patients with Head and Neck Cancer
The purpose of this study is to determine the if adding EGFS AS DNA to standard cetuximab and radiation when treating people with head and neck cancer is a safe and effective treatment. The primary objective is to evaluate the safety of combining intratumoral EGFS AS DNA with standard cetuximab and radiation when treating people with head and neck cancer that cannot be removed surgically. The study will enroll between 11 and 42 participants from the Cancer Therapy and Research Center in San Antonio. In addition to other conditions for enrollment, eligible patients have SCCHN tumors that are suitable for intratumoral injections of EGFR AS and are candidates for loco-regional radiation treatments. EGFR AS is administered by direct intratumoral injection using direct visualization, endoscopy, or imaging-guidance (ultrasound) as determined clinically.