An Assessment of an Attenuated Live Listeria Vaccine in CIN 2+ (ADXS11-001)

July 26, 2016 updated by: Advaxis, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Worldwide, many women carry HPV and cervical cancer is the leading cancer killer of women under the age of 50. Although its consequences are considerably less severe in the US, it leads to considerable morbidity. Many published clinical trials describe the immunotherapeutic treatment of early stage, pre-invasive, cervical cancer. It is widely recognized that immunotherapies are most effective in early stage disease because the immune system is least debilitated and disease burden is lowest. Invasive cervical cancer is preceded by a long, slowly progressive, pre-invasive phase termed Cervical Intraepithelial Neoplasia (CIN), which allows for this therapeutic approach. An ideal therapy would result in the remission of CIN 2/3 without damage to cervical tissue. A National Institute of Cancer panel charged with achieving consensus on this issue concluded that a non-surgical medical treatment for this indication would be valuable

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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • New Horizons Women's Care, LLC
      • Phoenix, Arizona, United States, 85032
        • Precision Trials
      • Phoenix, Arizona, United States, 85016
        • Arizona OB/GYN Affiliates, PC
      • Tucson, Arizona, United States, 85712
        • Visions Clinical Research - Tucson
    • California
      • La Mesa, California, United States, 91942
        • Grossmont Center for Clinical Research
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Visions Clinical Research
      • Lake Worth, Florida, United States, 33461
        • Altus Research
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Center for Women
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Dept. of OB/GYN Oncology
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center
      • New York, New York, United States, 10038
        • New York Downtown Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University
    • Texas
      • San Antonio, Texas, United States, 78217
        • InVisions Consultants, LLC
      • San Antonio, Texas, United States, 78212
        • InVisions Consultants, LLC- c/o Institute for Women's Health
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Wasatch Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: 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.
Experimental: 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.
Biological: 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.
Experimental: 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.
Biological: 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 Comparator: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary end point will be a histologic determination of whether CIN 2/3 present at entry had regressed.
Time Frame: 11 months
11 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 11 months
11 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advaxis, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

April 20, 2010

First Submitted That Met QC Criteria

May 3, 2010

First Posted (Estimate)

May 4, 2010

Study Record Updates

Last Update Posted (Estimate)

July 27, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lm-LLO-E7-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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