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Vaccine to Prevent Cervical Cancer
Untitled Document
Name of the Trial
Phase II Randomized Study of SGN-00101 Vaccine in Human Papillomavirus-16-Positive
Patients with Atypical Squamous Cells of Undetermined Significance or Low-grade Squamous
Intraepithelial Lesions of the Cervix (UCIRVINE-02-55). See the protocol summary 3.
Principal Investigators
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Dr. Bradley J. Monk and Dr. Dorothy J. Wiley
Principal Investigators |
Dr. Bradley J. Monk, University of California, Irvine, and Dr. Dorothy J. Wiley,
University of California, Los Angeles.
Why Is This Trial Important?
Human papillomavirus (HPV) infection is common among women throughout the world.
It is responsible for nearly all cervical cancers and most cell changes associated
with low- and high-grade
Pap test abnormalities.
Some types of HPV are associated with cervical cancer more often than others;
for example, HPV-Type 16 (HPV-16) is found in half of cervical cancers worldwide.
However, the vast majority of women infected with HPV-16 will never develop
cervical cancer and will clear their infections spontaneously because of immune
responses to the virus. Nonetheless, developing therapeutic interventions for
viral infections associated with low-grade cellular changes may allow us to
block the effects of HPV long before a precancerous change or a malignancy develops.
In this study, researchers are testing a vaccine in women infected with HPV-16
who have LSIL or ASCUS Pap test results. The goal is to determine whether
women
who receive the study vaccine clear their infections and resolve their low-grade
Pap test abnormalities more often than women who receive placebo (sterile water).
"Some women with HPV infections develop cancer because they don't seem
to develop an appropriate immune response to the cancer-causing components of
HPV," said Dr. Wiley. "We hope that this vaccine will help women develop
that immune response."
Contact Information
This clinical trial is no longer accepting new patients. To locate other clinical
trials for cervical cancer, search the NCI database of
clinical trials 1 or contact the NCI Cancer Information Service at 1-800-4-CANCER
(1-800-422-6237). The toll-free call is confidential.
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