Cervical and other ano-genital cancer is one of the major cancer types for which new immune-based cancer treatments are currently in development. This page features information on cervical cancer and immunotherapy clinical trials for cervical cancer patients, and highlights the Cancer Research Institute’s role in working to bring effective immune-based cancer treatments to people with cervical cancer.
Human papillomavirus (HPV) causes more human cancers than any other virus. It is thought to cause nearly all cases of cervical cancer and 70 percent of oropharyngeal (head and neck) cancers, which are cancers occurring at the back of the throat. It is estimated that HPV causes 90 percent of anal cancers, 75 percent of vaginal cancers, 70 percent of vulvar cancers, and 60 percent of penile cancers.
Cervical cancer is the third most frequently diagnosed cancer among women worldwide. In the U.S. in 2013, there were 12,340 new cases of invasive cervical cancer and 4,030 deaths. Globally, there are approximately 530,000 cases of cervical cancer per year in the world, and 265,000 deaths. Across the board, the 1-year survival rate for cervical cancer is 87%, while the 5-year rate is 68%. However, if the cancer is localized, the 5-year survival rate is 91%. Although cervical cancer is treatable when it is caught locally, the regional and distant stages are 57% and 16%.
Cervical cancer is usually a slow-growing cancer that may not have symptoms, but can be found with regular Pap tests (a procedure in which cells are scraped from the cervix and looked at under a microscope). Mortality rates have been decreasing in the U.S., thanks largely to widespread use of the Pap test as a screening tool.
Symptoms tend not to occur until the cancer has become invasive. Abnormal vaginal bleeding is the most common sign of cervical cancer. Two vaccines, Gardasil and Cervarix, prevent against the two strains of HPV that cause most cervical cancers, HPV 16 and 18. Gardasil also protects against HPV 6 and 11, the strains that cause most genital warts. Men between the ages of 9 and 26 may also receive a Gardasil vaccine to protect against anal cancer, as well as precancerous lesions. The addition to the Pap test, DNA tests can also detect HPV strains that pose a cervical cancer risk.
The countries that do not have Gardasil or Cervarix, as well as countries with women and men too old to be eligible to get the preventive vaccine, will benefit from therapeutic immunological approaches.
There are two clinical trials testing pNGVL4a/E7 (Detox)/HSP70 DNA vaccine in patients with HPV16+ cervical intraepithelial neoplasia 2/3, taking place at the Sidney Kimmel Comprehensive Cancer Center. The first one will determine the best dose (NCT00988559) and the second one will be combined with imiquimod (NCT00788164).
There are two clinical trials testing ipilimumab (Yervoy) in cervical cancer. The first one is for HPV+ cervical cancer that is metastatic or recurrent, which is currently recruiting (NCT01693783), and the second is chemoradiation followed by ipilimumab for patients with locally advanced cervical cancer, which is scheduled to be completed soon (NCT01711515).
A vaccine against the E7 protein, which is made by HPV and causes cervical cancer, called Lovaxin C (ADXS11-001; Lm-LLO-E7) is in phase II trials. It is being tested in cervical intraepithelial neoplasia by the biopharma company Advaxis, Inc. (NCT01116245). (This was slated for completion last April 2013, June 2013.)
There is a phase II study of white blood cells from the patient's own tumor that is being conducted at the National Institutes of Health Clinical Center against HPV-related cancer (NCT01585428).
Since 1994, Cancer Research Institute (CRI) has given out more than $4 million dollars for cervical cancer and human papillomavirus research. One of the grants paved the way for the cervical cancer vaccine, named Gardasil, which was developed by Ian H. Frazer, M.D., FRCPA. CRI gave several grants to him; the first was in 1999, to specify "Genotype specific and genotype cross reactive cell mediated immunity to virus-like particles (VRP) based papillomavirus vaccines," which he credits as being important to the development of Gardasil. In 2006, the FDA approves the cervical cancer vaccine Gardasil, which protects against two types of HPV that cause approximately 70 percent of all cases of cervical cancer worldwide.
“This new vaccine that prevents cervical cancer grew out of research funded by CRI.”
– Professor Ian Frazer, 2003 CRI Annual Report
In the therapeutic vaccine space, CRI has made a big splash with the research of Sjoerd van der Burg, Ph.D., and Cornelis (Kees) Melief, M.D., Ph.D., at Leiden University Medical Center, who found that their vaccine could demonstrate durable complete responses in some women with HPV-16+ vulvar intraepithelial neoplasias (VINs), a disease that normally has a spontaneous regression rate of less than 2%.
Sources: Cancer Facts and Figures 2013, CDC HPV-Associated Cancers, National Cancer Institute, Globocan 2008, CRI grantee documents
[i] Kenter GG, Welters MJ, Valentijn AR, Lowik MJ, Berends-van der Meer DM, Vloon AP, Essahsah F, Fathers LM, Offringa R, Drijfhout JW, Wafelman AR, Oostendorp J, Fleuren GJ, van der Burg SH, Melief CJ. Vaccination against HPV-16 oncoproteins for vulvar intraepithelial neoplasia. N Engl J Med 2009 Nov 5; 361: 1838-1847. (PMID: 19890126)
Last Updated February 2014
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