Trial Tests New Gel for Cervical Cancer Prevention

CINCINNATI—Scientists at the University of Cincinnati (UC) are testing a new, once-a-day gel that may halt the development of cervical cancer in certain women and destroy the virus believed to cause the disease.

Led locally by Nader Husseinzadeh, MD, this national, phase-2 trial will evaluate the effectiveness of the topical gel, applied to the cervix through the vagina, in women who have a precancerous condition called high-grade cervical intraepithelial neoplasia. Left untreated, about 15 percent of these cases will progress to cancer.

Researchers nationwide will test the drug on 250 women, 18 or older, who have this advanced neoplasia as well as confirmed human papilloma virus infection, a condition often transmitted sexually that previous research has linked to cervical cancer. Participants must also be using a hormonal birth control method.

“Women with human papilloma virus infections are at an increased risk of developing cervical cancer,” explains Husseinzadeh, a professor of gynecology at UC and principal investigator of more than 30 clinical trials. “We have procedures to remove the abnormal tissue, but they don’t protect against future or reoccurring papilloma virus infections and can cause complications during childbirth.

“Clearly there is a medical need for a less invasive treatment option—such as a gel or pill—that yields better overall results for these women.”

The topical drug works by activating a specific receptor on the surface of T-cells, a type of white blood cell involved in fighting off infection. The activated T-cells block the papilloma virus antigen, the substance that actually triggers the body’s defense mechanism, and stops the transition from cellular abnormality to cancer.

“Preliminary research suggests this gel may substantially reduce the papilloma virus infection and reduce the risk of cervical cancer,” says Husseinzadeh.

Study participants are randomized into two treatment groups. The first group uses the gel for five consecutive days, stops for 23 days, and then repeats the process for two months. The second group goes through the same process, but with an inactive gel.

Women have regular physical exams and blood tests and biweekly colposcopy exams, a method of examining abnormal cells in the cervix using a special light to determine if the precancerous lesions are responding to treatment.

The study participants will return in four months to have any remaining abnormal tissue removed.

The American Cancer Society estimates that about 9,700 women—nearly 400 of them from Ohio—will be diagnosed with cervical cancer in 2006. The disease, most common in women over 40, will also result in about 3,700 deaths.

This trial is sponsored by Tigris Pharmaceuticals, maker of the investigational gel. Husseinzadeh has no financial interest in the company, but study participants are compensated for their time.  For more informationon gynecological clinical trials, call Rose Maxwell at (513) 584-4509.