Cervical Intraepithelial Neoplasia Clinical Trial
— ADXS11-001Official title:
A Randomized, Single Blind, Placebo Controlled Phase 2 Study to Assess the Safety of ADXS11-001 for the Treatment of Cervical Intraepithelial Neoplasia Grade 2/3
Verified date | July 2016 |
Source | Advaxis, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Cervical cancer is associated with Human Papilloma Virus. About 57% of cervical cancer is the result of infection by Human Papilloma Virus strain 16 (HPV-16). HPV is a very common virus that can affect the cells of the cervix. E7 is a substance that is made by the HPV virus which causes cervical cancer. The purpose of the study is to test the safety, tolerability (how the drug makes you feel), immunology (effects on the immune system) and efficacy (disease curing effects) of a vaccine called Lovaxin C against E7. The vaccine is designed to cause the immune system to react against the E7 substance in a manner that is intended to reverse the changes to the cervix and prevent cervical cancer from occurring.
Status | Terminated |
Enrollment | 81 |
Est. completion date | April 2016 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Histologically confirmed CIN 2/3 that requires surgical intervention Exclusion Criteria: - Previous history of listeriosis - Steroid use - Antibiotic use - Negative anergy panel - HIV positive - Pregnant or actively trying during the treatment period - Intercurrent disease |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Visions Clinical Research | Boynton Beach | Florida |
United States | Montefiore Medical Center | Bronx | New York |
United States | New Horizons Women's Care, LLC | Chandler | Arizona |
United States | Center for Women | Chicago | Illinois |
United States | Indiana University Dept. of OB/GYN Oncology | Indianapolis | Indiana |
United States | Grossmont Center for Clinical Research | La Mesa | California |
United States | Altus Research | Lake Worth | Florida |
United States | New York Downtown Hospital | New York | New York |
United States | Temple University | Philadelphia | Pennsylvania |
United States | Arizona OB/GYN Affiliates, PC | Phoenix | Arizona |
United States | Precision Trials | Phoenix | Arizona |
United States | Wasatch Clinical Research | Salt Lake City | Utah |
United States | InVisions Consultants, LLC | San Antonio | Texas |
United States | InVisions Consultants, LLC- c/o Institute for Women's Health | San Antonio | Texas |
United States | Visions Clinical Research - Tucson | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Advaxis, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary end point will be a histologic determination of whether CIN 2/3 present at entry had regressed. | 11 months | Yes | |
Secondary | Secondary efficacy endpoints include whether HPV DNA was reduced or eliminated and a comparison of their excised cervical tissue controls to assess the extent of disease in treated vs. untreated patients. | 11 months | No |
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