New Gel May Reduce Cervical Cancer Risk
Published September 2006
By With more than 9,000 cases of cervical cancer diagnosed each year, some in women who are still in their teens, UC gynecological cancer expert Nader Husseinzadeh, MD, says a few things need to change.
”Infection from the human papilloma virus is a chief risk factor associated with cervical cancer, and most infections are transmitted sexually, so women must make safe sex a priority,” he says.
“Research has shown us that women with human papilloma virus infections are at increased risk of developing cervical cancer.”
He believes a new once-a-day gel, being tested locally at UC, may halt the development of cervical cancer in certain women and even help destroy the virus causing it.
“We can remove abnormal tissue with surgery, but that doesn’t protect against future or reoccurring papilloma virus infections, and the procedure itself can cause complications during childbirth,” Husseinzadeh adds.
”Clearly there’s a medical need for a less invasive treatment option—such as a gel or pill—that yields better overall results for these women.”
Researchers across the United States are involved in a phase 2 trial to test 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.
Women aged 18 or older who have this advanced neoplasia as well as confirmed human papilloma virus infection, a condition previous research has linked to cervical cancer, may be eligible for this study. Participants must also be using a hormonal birth control method.
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 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 to determine if the precancerous lesions are responding to treatment.
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 interests in the company but study participants are compensated for their time.
For more information on this study, call Rose Maxwell at (513) 584-4509.