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U.VA. LEADS CLINICAL TRIAL FOR OVARIAN CANCER DRUG

 

Doctors at the University of Virginia Health System are primary investigators for a national, clinical research study involving an experimental immunotherapy treatment that shows promise in delaying or preventing the relapse of ovarian cancer in women who achieve remission after surgery and chemotherapy.

Two identical studies, called IMPACT I and II, are being conducted simultaneously by gynecologic cancer specialists at U.Va. and the University of California-Los Angeles (UCLA). The pivotal, confirmatory Phase III trial involves a new antibody called OvaRex® that is thought to work by stimulating the body’s immune system to recognize ovarian cancer cells as foreign invaders, then attack them.

“The immune system is extraordinarily important in destroying cancers,” said Dr. Peyton T. Taylor, Jr., medical director and professor of obstetrics and gynecology at the U.Va. Cancer Center and principal investigator for the IMPACT II trial. “But the immune system is easily overwhelmed by a large number of cancer cells in the body. This drug targets women in remission who have a small number of ovarian cancer cells where the immune system could play a major role in controlling their disease. OvaRex® is an exciting therapy to potentially treat this very dangerous and often deadly disease.”

Phyllis Glick, 66, of Rockingham Co., Va., has been in remission from ovarian cancer since June of this year and is the first patient to be accepted into the latest OvaRex® trial at U.Va. “If I can beat this ovarian cancer down without taking more chemotherapy that means a lot,” Glick said. “Right now, I’m feeling great and I want to live to see my grandchildren. I’ll do anything to keep the cancer down and I’m glad they accepted me to participate in the study of this new treatment.”   

Ovarian cancer is the most deadly form of gynecological cancer. An estimated 25,000 women will be diagnosed with the disease in 2003, according to the American Cancer Society. About 14,300 this year will die of ovarian cancer. The disease is often detected at a late stage and is notoriously difficult to treat. Although the vast majority of women with advanced disease achieve remission with current therapy, a distressingly large number of these women relapse within two to three years, Taylor said. The usual treatment for women with ovarian cancer is surgery to have the tumor removed, followed by chemotherapy. Often, the ovaries, uterus, Fallopian tubes, and part of the bowel have to be removed as well. 

OvaRex® works through an antibody that targets a substance on the surface of cancer cells called CA125. “The body does not recognize CA125 as foreign,” Taylor said, “so there is a suppressed immune response to CA125-producing cells. What this particular product carries is an antibody that’s been modified and causes the body to recognize the cells producing CA125 as foreign. The body’s own immune system then destroys the cancer.”

The results of a previous clinical trial on the safety of OvaRex® showed no serious side effects and suggested a significant delay in relapse in some of the women who took part in the trial. These results were reported at a recent conference of The American Society of Clinical Oncologists. The Food and Drug Administration requires that the results be confirmed in those women who were felt to benefit from immunization with OvaRex®. IMPACT I and II are these confirmatory trials.

Not all ovarian cancer survivors are eligible for the trial. Taylor says the criteria for entrance into the study are: patients who manufacture the substance CA125; patients who have had successful initial surgery; patients who are responsive to chemotherapy; and patients who are in remission (based on a clinical and CT exam) at the end of six months of chemotherapy treatment.    

Taylor and other investigators hope to enroll about 350 women in the OvaRex® trial at about seventy participating sites around the nation. OvaRex® is being developed by Unither Pharmaceuticals of Wellesley Hills, Mass.   

August 7, 2003