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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01116245
Other study ID # Lm-LLO-E7-07
Secondary ID
Status Terminated
Phase Phase 2
First received April 20, 2010
Last updated July 26, 2016
Start date April 2010
Est. completion date April 2016

Study information

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

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Intervention

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.
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Advaxis, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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