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UIHC trial indicates gene therapy aids ovarian cancer treatments

IOWA CITY, Iowa -- A new ovarian cancer treatment strategy that researchers are testing at the University of Iowa Hospitals and Clinics looks promising.

According to preliminary results, it is possible to provide normal genes to ovarian cancer patients who have defective genes that may cause ovarian cancer. Researchers believe the gene therapy has promise because levels of the ovarian cancer antigen CA125 are reduced following the treatment. Both gene therapy alone and in combination with chemotherapy can cause significant reductions in CA125.

"There is strong rationale for this type of therapy and reason to believe that the gene transfer with chemotherapy will be more effective than chemotherapy alone," said Richard Buller, M.D., Ph.D., UI professor of obstetrics and gynecology, and pharmacology.

Buller, who is heading up the UIHC efforts, recently presented the initial phase I trial findings at the Seventh Annual International Conference on Gene Therapy for Cancer in San Diego.

The trials, which the Schering Plough Corp. is sponsoring, started in February 1997 at the UIHC. The University of California-Los Angeles and the University Ulm in Germany are also participating. Collectively, the sites enrolled 41 patients in the initial trial. The UIHC enrolled more than half of the subjects.

Here is the way the gene therapy works: Using a common, defective cold virus as a vector, or carrier, physicians send healthy copies of the p53 gene to cells to restore normal p53 function. Researchers believe that an altered p53 gene is partially responsible for the cancer because researchers have found that the gene is mutated in 75 percent of patients with advanced ovarian cancer. Researchers hope that by correcting the flawed gene in the patients' cells, they can fight the problem.

The team of investigators now is in the final stages of developing a randomized phase II/III trial, which will involve a much larger group of subjects, Buller said. The goal is to find out how effective the gene therapy is at improving the women's conditions.

Each year physicians diagnose 24,500 new cases of ovarian cancer. There are 14,500 deaths annually. Ovarian cancer is the fourth leading cause of cancer death in women behind lung, breast and colon cancers.