Clinical trial NCT01116245: An Assessment of an Attenuated Live Listeria Vaccine in CIN 2+
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cervical Intraepithelial Neoplasia
Keywords: Cervical Intraepithelial Neoplasia Stage 2/3
Lead sponsor: Advaxis, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-04
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: The primary end point will be a histologic determination of whether CIN 2/3 present at entry had regressed.
timeFrame: 11 months
Secondary outcomes:
measure: 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.
timeFrame: 11 months
Other outcomes:
Locations:
city: Chandler
country: United States
facility: New Horizons Women's Care, LLC
state: Arizona
city: Phoenix
country: United States
facility: Arizona OB/GYN Affiliates, PC
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials
state: Arizona
city: Tucson
country: United States
facility: Visions Clinical Research - Tucson
state: Arizona
city: La Mesa
country: United States
facility: Grossmont Center for Clinical Research
state: California
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Chicago
country: United States
facility: Center for Women
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Dept. of OB/GYN Oncology
state: Indiana
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: New York Downtown Hospital
state: New York
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: San Antonio
country: United States
facility: InVisions Consultants, LLC- c/o Institute for Women's Health
state: Texas
city: San Antonio
country: United States
facility: InVisions Consultants, LLC
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
Study officials:
References: