The first phase of the study is designed to test the safety of the treatment and determine the proper dosage of gene, said Dr. Dov Kadmon, professor of urology at BCM. It will be carried out in the department of urology at BCM as well as at Ben Taub General Hospital, The Methodist Hospital and Michael E. DeBakey Veterans Affairs Medical Center.
"We are treating patients who are scheduled for a prostatectomy (prostate removal) but who also have a high risk that their disease will recur (or come back)," said Kadmon. "The operation itself is highly successful in eradicating local tumors (in the prostate)."
The design of the study is simple, said Kadmon.
"One injection into the prostate that should take no more than 10 minutes, although patients will be monitored in a special unit of the hospital for 23 hours to make sure there are no side effects. After that, they come to the unit for a check-up once a week."
After about 30 days, the subjects undergo their surgery, which has already been scheduled, he said. He said the hope is that the gene therapy will reduce the risk that cancer will recur at or near the site of the tumor as well as in distant points in the body.
"We hope that by generating a systemic immune response, we are enabling the body to destroy prostate cancer cells that have moved elsewhere," he said. Kadmon and his colleagues plan to test six different doses of the gene.
The gene therapy involves attaching an inactivated adenovirus (related to viruses that cause respiratory infections) to the RTVP-1 gene. As the virus infects the tumor cells, it will introduce the gene into the cells as well. (RTVP stands for related to testes-specific, vespid and pathogenesis proteins.) The RTVP-1 gene was is
Source:Baylor College of Medicine