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A phase 2 trial of surgery with perioperative INGN 201 (Ad5CMV-p53) gene therapy followed by chemoradiotherapy for advanced, resectable squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx: report of the Southwest Oncology Group.
Arch Otolaryngol Head Neck Surg
September 2009
Department of Otolaryngology, Head and Neck Surgery, Wayne State University, University Health Center 5-E, 4201 St Antoine, Detroit, MI 48201, USA.
Objective: To assess the feasibility of treating patients with high-risk stage III and IV squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx with perioperative adenovirus-p53 (INGN 201) gene therapy along with surgery and chemoradiotherapy.
Design And Setting: A phase 2 study in a multi-institutional setting within the Southwest Oncology Group.
Patients: Thirteen individuals who met the following entry criteria: newly diagnosed, previously untreated squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx; selected stage III or IV disease without distant metastases; and surgically resectable disease.