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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

Phase 2
18 Years
45 Years
Open (Enrolling)
Cervical Intraepithelial Neoplasia

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Trial Information

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

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.

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

- Penicillin allergy

Type of Study:


Study Design:

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

Outcome Measure:

The primary end point will be a histologic determination of whether CIN 2/3 present at entry had regressed.

Outcome Time Frame:

11 months

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2010

Completion Date:

June 2013

Related Keywords:

  • Cervical Intraepithelial Neoplasia
  • Cervical Intraepithelial Neoplasia Stage 2/3
  • Neoplasms
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ



Montefiore Medical CenterBronx, New York  10467-2490
Temple UniversityPhiladelphia, Pennsylvania  19140
Visions Clinical ResearchBoynton Beach, Florida  33472
New York Downtown HospitalNew York, New York  10038
Precision TrialsPhoenix, Arizona  85032
Altus ResearchLake Worth, Florida  33461
Wasatch Clinical ResearchSalt Lake City, Utah  84107
New Horizons Women's Care, LLCChandler, Arizona  85224
Arizona OB/GYN Affiliates, PCPhoenix, Arizona  85016
Visions Clinical Research - TucsonTucson, Arizona  85712
Grossmont Center for Clinical ResearchLa Mesa, California  91942
Center for WomenChicago, Illinois  60612
Indiana University Dept. of OB/GYN OncologyIndianapolis, Indiana  46202
InVisions Consultants, LLCSan Antonio, Texas  78217
InVisions Consultants, LLC- c/o Institute for Women's HealthSan Antonio, Texas  78212