An Assessment of an Attenuated Live Listeria Vaccine in CIN 2+
NCT ID: NCT01116245
Last Updated: 2016-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
81 participants
INTERVENTIONAL
2010-04-30
2016-04-30
Brief Summary
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Detailed Description
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The primary objectives of this trial are to test three doses of Lovaxin C to determine if vaccination with Lovaxin C in women with CIN 2/3 for whom surgery is indicated can safely reverse the disease compared to placebo treated control patients.
An earlier Phase 1/2 trial of Lovaxin-C in late stage metastatic cervical cancer used a regimen of two doses given with a 28-day interval. That regimen was shown to be safe and to generate reduction in tumor burdens in some patients. In this trial we will treat earlier stage disease in healthier patients with better immune systems, will use the same and lower doses as given before, but add an additional dosing to the regimen by administering the lowest dose that we assessed previously and by adding a third vaccination to the prior regimen. Unlike the phase 1 trial in which 2 doses were given with a 3 week separation, dosing in the proposed trial will be separated by 4-week intervals.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Low Dose
5x10\^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.
ADXS11-001 (Lm-LLO-E7)
ADXS11-001 at one of three dose levels given as 3 vaccinations separated by 4 weeks with an oral antibiotic regimen subsequent to dosing.
Middle Dose
3.3x10\^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.
ADXS11-001 (Lm-LLO-E7)
ADXS11-001 at one of three dose levels given as 3 vaccinations separated by 4 weeks with an oral antibiotic regimen subsequent to dosing.
High Dose
1x10\^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.
ADXS11-001 (Lm-LLO-E7)
ADXS11-001 at one of three dose levels given as 3 vaccinations separated by 4 weeks with an oral antibiotic regimen subsequent to dosing.
Placebo
normal 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.
Placebo Control
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.
Interventions
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ADXS11-001 (Lm-LLO-E7)
ADXS11-001 at one of three dose levels given as 3 vaccinations separated by 4 weeks with an oral antibiotic regimen subsequent to dosing.
Placebo Control
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
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Inclusion Criteria
Exclusion Criteria
* Steroid use
* Antibiotic use
* Negative anergy panel
* HIV positive
* Pregnant or actively trying during the treatment period
* Intercurrent disease
18 Years
45 Years
FEMALE
No
Sponsors
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Advaxis, Inc.
INDUSTRY
Responsible Party
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Locations
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New Horizons Women's Care, LLC
Chandler, Arizona, United States
Arizona OB/GYN Affiliates, PC
Phoenix, Arizona, United States
Precision Trials
Phoenix, Arizona, United States
Visions Clinical Research - Tucson
Tucson, Arizona, United States
Grossmont Center for Clinical Research
La Mesa, California, United States
Visions Clinical Research
Boynton Beach, Florida, United States
Altus Research
Lake Worth, Florida, United States
Center for Women
Chicago, Illinois, United States
Indiana University Dept. of OB/GYN Oncology
Indianapolis, Indiana, United States
New York Downtown Hospital
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Temple University
Philadelphia, Pennsylvania, United States
InVisions Consultants, LLC- c/o Institute for Women's Health
San Antonio, Texas, United States
InVisions Consultants, LLC
San Antonio, Texas, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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Lm-LLO-E7-07
Identifier Type: -
Identifier Source: org_study_id
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