title: Adenoviral p53 gene therapy in squamous cell cancer of the head and neck region.
abstract: Treatment options for recurrent head and neck squamous cell carcinoma are limited. Morbidity and mortality are largely related to local recurrence. Experimental investigation of adenoviral p53 gene therapy is being explored as a new therapeutic modality for patients with recurrent squamous cell carcinoma in the head and neck region. The function of the p53 gene is to maintain the genetic integrity of the cell and induce apoptosis when DNA damage is irreparable. Phase I trial results indicate that multiple injections of up to 2.5 x 10(12) viral particles per injection administered during a 3-week cycle are well tolerated and demonstrate evidence of local regional control. Dose-related activity correlating with transient survival advantage is demonstrated in a meta-analysis of phase II trials. This review will summarize phase I and II trial results. Conclusions drawn from these studies justify the currently ongoing phase III investigation.
authors.affiliation: US Oncology Inc, Collins Building, 3535 Worth Street, Dallas, TX 75246, USA. John.Nemunaitis@USOncology.com
authors.forename: Jerry
authors.initials: J
authors.lastname: Edelman
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Edelman
authors.forename: John
authors.initials: J
authors.lastname: Nemunaitis
mesh_terms: D000256:Adenoviridae / Q000235:genetics* / Q000378:metabolism; D000818:Animals; D002294:Carcinoma, Squamous Cell / Q000235:genetics / Q000628:therapy*; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D018014:Gene Transfer Techniques; D016158:Genes, p53; D015316:Genetic Therapy / Q000379:methods*; D005822:Genetic Vectors; D006258:Head and Neck Neoplasms / Q000235:genetics / Q000628:therapy*; D006801:Humans