Vaccine to Prevent Cervical Cancer
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.
Dr. Bradley J. Monk, University of California, Irvine, and Dr. Dorothy J. Wiley, University of California, Los Angeles
Why Is This Trial Important?
Cervical cancer strikes about 15,000 American women each year. Cervical cancer starts in cells that form the surface of the cervix (squamous epithelium). Certain changes in these cells are often detected by Pap testing, where early and minor effects associated with human papillomavirus (HPV) infection show up as low-grade squamous intraepithelial lesions (LSIL) or atypical squamous cells of undetermined significance (ASCUS). These abnormalities may be early precursors of cervical cancer.
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. In this study, researchers are testing a vaccine in women infected with HPV-16 who have cell changes associated with HPV infection (LSIL or ASCUS). The goal is to determine whether the vaccine will help develop the appropriate immune response to resolve these low-grade cervical cell changes and clear the viral infection.
"About 25 percent of women with LSIL and 5 percent of women with ASCUS are infected with HPV-16, so we will need to screen approximately 2,600 women to find the 140 who will go on to be part of the vaccine portion of the study," said Dr. Wiley.
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 University of California, Irvine and at the University of California, Los Angeles' Jonsson Comprehensive Cancer Center.
Who to Contact
For more information, contact the NCI Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) or you may contact the study directly at 1-310-825-0540 (UCLA) or 1-888-456-7067 (UCI). The call is confidential.
An archive of "Featured Clinical Trial" columns is available at http://cancer.gov/clinicaltrials/ft-all-featured-trials.