| [ Summary ] |
Esophageal cancer is a highly malignant disease, in which progression of the disease is observed in most patients, even during the first medical examination. Although combination therapies consisting of radiation and anti-cancer drug sexist, no satisfactory treatment regimen has yet been established, due to resistance acquisition. Based on the concepts of genetic alteration in carcinogenesis, gene therapy for cancer has been rapidly developing. We reported on the growth inhibitory effects of adenovirus-mediated wild type p53 gene transfer into esophageal squamous carcinoma cell lines. After extensive pre-clinical study of p53 gene therapy in vitro and in vivo, we are conducting a phase I/II clinical trial. The target of this trial is those patients with unresectable esophageal cancer, which is resistant to chemoradiotherapy.
After giving informed consent, the first patient received injections of Ad5 CMV-p53 on December 19, 2000. Up to April 1, 2003, nine patients were enrolled in this trial. No serious adverse events have occurred so far in these patients, and the trial has been safely conducted. |