IL-2 GENE-THERAPY OF ADVANCED LUNG-CANCER PATIENTS

We report here Phase I clinical-trial studies of retroviral-mediated i nterleukin-2 (IL-2) gene transfer to tumor-infiltrating lymphocytes th at are re-infused to advanced lung cancer patients with pleural effusi ons. Ten lung cancer patients with malignant pleural effusions for who m all conventional therapy had failed were included in this Phase I pr otocol. Tumor infiltrating lymphocytes (TIL) from the patients were ex posed to the retroviral plasmid pL(IL-2)SN containing the human IL-2 g ene. Approximately 1-6 x 10(10) TIL cells transfected with IL-2 were r e-infused into the chest cavity of each patient. The toxicity of this treatment with TIL/IL-2 gene therapy in these patients was minimal wit h transient slight fever of approximately 37.5. Pleural effusions did not re-accumulate for at least 4 weeks in six of ten patients. One pat ient was observed to have not only the resolution of the pleural effus ions, but in addition the size of the original tumor decreased as seen by CT. The clinical results indicate this method of cancer gene thera py is safe and possibly efficacious against pleural effusions due to a dvanced lung cancer.