Ad& - p53 Clinical Trial in Patients with Squamous Cell Carcinoma
Gary L. Clayman, Douglas K. Frank, and Patricia A. Bruso
Our laboratory has been involved in the investigation of wild type p53 gene transfer for the selective induction of apoptosis in human upper aerodigestive tract squamous cell carcinoma of the head and neck (SCCHN). Transient overexpression of the wild type p53 gene in various malignancies has been explored as a potential therapeutic intervention strategy. This strategy is based on the role that wild type p53 plays as a tumor suppressor gene and inducer of cell-cycle arrest and apoptosis. SCCHN is a devastating disease. The overall poor survival rate for these tumors has not changed over the last several decades with current standard treatment modalities (radiation, surgery, chemotherapy). After undergoing standard therapy (including radiotherapy), the advanced stage and recurrent SCCHN patient has a poor prognosis, and treatment often has major effects upon cosmesis and function. The principal cause of death in SCCHN is local/regional recurrence. Clearly, new treatment strategies need to be developed and investigated. Given these issues, the study of novel molecular intervention therapies involving genes such as wild type p53 seemed appropriate. The fact that local/regionally recurrent SCCHN is readily accessible, even in the most advanced cases, enhanced its candidacy for investigation as a target for wild type p53 molecular intervention.