Study Stopped
Study stopped due to lack of enrollment
An Assessment of an Attenuated Live Listeria Vaccine in CIN 2+
ADXS11-001
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
1 other identifier
interventional
81
1 country
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2010
Longer than P75 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 20, 2010
CompletedFirst Posted
Study publicly available on registry
May 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedJuly 27, 2016
July 1, 2016
3.7 years
April 20, 2010
July 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary end point will be a histologic determination of whether CIN 2/3 present at entry had regressed.
11 months
Secondary Outcomes (1)
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
Study Arms (4)
Low Dose
EXPERIMENTAL5x10\^7 cfu x 3 intravenous infusions at 28 day intervals. All infusions will be preceded by prophylactic NSAID and antihistamine, and followed 3d later with antibiotic.
Middle Dose
EXPERIMENTAL3.3x10\^8 cfu x 3 intravenous infusions at 28 day intervals. All infusions will be preceded by prophylactic NSAID and antihistamine, and followed 3d later with antibiotic.
High Dose
EXPERIMENTAL1x10\^9 cfu x 3 intravenous infusions at 28 day intervals. All infusions will be preceded by prophylactic NSAID and antihistamine, and followed 3d later with antibiotic.
Placebo
PLACEBO COMPARATORnormal saline x 3 intravenous infusions at 28 day intervals. All infusions will be preceded by prophylactic NSAID and antihistamine, and followed 3d later with antibiotic.
Interventions
ADXS11-001 at one of three dose levels given as 3 vaccinations separated by 4 weeks with an oral antibiotic regimen subsequent to dosing.
3 intravenous infusions of normal saline at 28 day intervals. All infusions will be preceded by prophylactic NSAID and antihistamine, and followed 3d later with antibiotic.
Eligibility Criteria
You may qualify if:
- Histologically confirmed CIN 2/3 that requires surgical intervention
You may not qualify if:
- Previous history of listeriosis
- Steroid use
- Antibiotic use
- Negative anergy panel
- HIV positive
- Pregnant or actively trying during the treatment period
- Intercurrent disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Advaxis, Inc.lead
Study Sites (15)
New Horizons Women's Care, LLC
Chandler, Arizona, 85224, United States
Arizona OB/GYN Affiliates, PC
Phoenix, Arizona, 85016, United States
Precision Trials
Phoenix, Arizona, 85032, United States
Visions Clinical Research - Tucson
Tucson, Arizona, 85712, United States
Grossmont Center for Clinical Research
La Mesa, California, 91942, United States
Visions Clinical Research
Boynton Beach, Florida, 33472, United States
Altus Research
Lake Worth, Florida, 33461, United States
Center for Women
Chicago, Illinois, 60612, United States
Indiana University Dept. of OB/GYN Oncology
Indianapolis, Indiana, 46202, United States
New York Downtown Hospital
New York, New York, 10038, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
InVisions Consultants, LLC- c/o Institute for Women's Health
San Antonio, Texas, 78212, United States
InVisions Consultants, LLC
San Antonio, Texas, 78217, United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2010
First Posted
May 4, 2010
Study Start
April 1, 2010
Primary Completion
December 1, 2013
Study Completion
April 1, 2016
Last Updated
July 27, 2016
Record last verified: 2016-07