Safety and toxicity of catheter gene delivery to the pulmonary vasculature in a patient with metastatic melanoma.

One approach to gene therapy for human cancer is transcatheter injection of DNA liposomes into tumor masses. To determine the feasibility of selective delivery of recombinant genes by a catheter to the pulmonary vasculature in humans, a patient with melanoma received two treatments of HLA-B7 plasmid DNA complexed to cationic liposomes into a right posterior basal pulmonary artery associated with a mass lesion. The treatments were well tolerated. No adverse respiratory, cardiac, immunologic, or other organ toxicities were detected. The delivery of recombinant genes by catheter may be a useful modality to treat human malignancy and other diseases.