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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01116245
Recruitment Status : Terminated (Study stopped due to lack of enrollment)
First Posted : May 4, 2010
Last Update Posted : July 27, 2016
Sponsor:
Information provided by (Responsible Party):
Advaxis, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Biological: ADXS11-001 (Lm-LLO-E7) Drug: Placebo Control Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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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.


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

Secondary Outcome Measures :
  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. [ Time Frame: 11 months ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01116245


Locations
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United States, Arizona
New Horizons Women's Care, LLC
Chandler, Arizona, United States, 85224
Arizona OB/GYN Affiliates, PC
Phoenix, Arizona, United States, 85016
Precision Trials
Phoenix, Arizona, United States, 85032
Visions Clinical Research - Tucson
Tucson, Arizona, United States, 85712
United States, California
Grossmont Center for Clinical Research
La Mesa, California, United States, 91942
United States, Florida
Visions Clinical Research
Boynton Beach, Florida, United States, 33472
Altus Research
Lake Worth, Florida, United States, 33461
United States, Illinois
Center for Women
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University Dept. of OB/GYN Oncology
Indianapolis, Indiana, United States, 46202
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
New York Downtown Hospital
New York, New York, United States, 10038
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
United States, Texas
InVisions Consultants, LLC- c/o Institute for Women's Health
San Antonio, Texas, United States, 78212
InVisions Consultants, LLC
San Antonio, Texas, United States, 78217
United States, Utah
Wasatch Clinical Research
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Advaxis, Inc.
More Information
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Responsible Party: Advaxis, Inc.
ClinicalTrials.gov Identifier: NCT01116245    
Other Study ID Numbers: Lm-LLO-E7-07
First Posted: May 4, 2010    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016
Keywords provided by Advaxis, Inc.:
Cervical Intraepithelial Neoplasia Stage 2/3
Additional relevant MeSH terms:
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Neoplasms
Carcinoma in Situ
Uterine Cervical Dysplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Precancerous Conditions
 Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases