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