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 at http://cancer.gov/clinicaltrials/UCIRVINE-02-55.

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."

Who Can Join This Trial?
Researchers seek to enroll approximately 140 patients aged 18 to 50 who have Pap tests showing ASCUS or LSIL. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/UCIRVINE-02-55.

Where Is This Trial Taking Place?
The study is being conducted at the Chao Family Comprehensive Cancer Center at UC-Irvine and at UCLA's Jonsson Comprehensive Cancer Center.

Contact Information
See the list of study contacts at http://cancer.gov/UCIRVINE-02-55 or contact the NCI Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The toll-free call is confidential.