Gene therapy for lung cancer

Lung cancer is the leading cause of cancer death in Japanese male. The high mortality rate of lung cancer is resulted from the absence of standard therapeutic strategies especially for advanced cancer. Because alteration of p53 is observed in 40 to 50% of non-small cell lung cancer, p53 seems to be one of critical molecules for its development. In vitro and in vivo experiments showed the effectiveness and usefulness of the wild-type p53 expression adenovirus vector (Ad5CMVp53). Based on these data the clinical trial for advanced non-small cell lung cancer using Ad5CMVp53 has started from 1995 in United States and also started in our university from March 1999. No serious toxicity and some effective cases were reported in phase I study of United States. The protocol of this trial is introduced here.