A Study of Amolimogene (ZYC101a) in Patients With High Grade Cervical Intraepithelial Lesions of the Uterine Cervix

May 21, 2013 updated by: Eisai Inc.

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of Amolimogene (ZYC101a) in the Treatment of High-Grade Cervical Intraepithelial Lesions (CIN 2/3) of the Uterine Cervix

The purpose of this study is to evaluate the efficacy and safety of amolimogene, in the treatment of patients with high-grade cervical intraepithelial lesions of the uterine cervix.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a double-blind study, so neither the patient not the doctor will know which treatment has been assigned.

Study Type

Interventional

Enrollment (Actual)

251

Phase

  • Phase 2
  • Phase 3

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
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • University of Alabama
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Arizona Wellness Center for Women/Precision Trials, LLC
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • California
      • Colton, California, United States, 92324
        • Arrowhead Regional Medical Center
      • Palm Springs, California, United States, 92262
        • The Center for Advanced Research and Education, Inc.
      • San Diego, California, United States, 92108
        • Medical Center for Clinical Research
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Physicians Research Options, LC
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Visions Clinical Research
      • Miami, Florida, United States, 33136
        • University of Florida, Miami
      • Sarasota, Florida, United States, 34239
        • Physician Care Clinical Research
      • Tampa, Florida, United States, 33613
        • Insignia Clinical Research
      • West Palm Beach, Florida, United States, 33409
        • Comprehensive Clinical Trials LLC
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia, Department of Family Medicine
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rosemark Women's Care Specialists
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Nevada
      • North Las Vegas, Nevada, United States, 89030
        • Centennial Hills OB-GYN Associaties
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Southwest Clinical Research
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Lyndhurst Gynecologic Associates
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • The University of Oklahoma Health Sciences Center, Center for Research in Women's Health
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple Center for Women's Health
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Sarah Cannon Research
      • Nashville, Tennessee, United States, 33437
        • Michael Altenbern, MD
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center at Dallas
    • Utah
      • Pleasant Grove, Utah, United States, 84062
        • Physicians' Research Options
      • Sandy, Utah, United States, 84070
        • Physicians' Research Options, LLC
    • Virginia
      • Virginia Beach, Virginia, United States, 23456
        • Tidewater 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

13 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

To be considered for enrollment, patients must:

  1. Have an abnormal Pap smear (atypical squamous cells of undetermined significance [ASCUS], atypical squamous cells, cannot exclude high grade [ASC-H], low grade squamous intraepithelial lesion [LSIL], high grade squamous intraepithelial lesion [HSIL]) result within 6 months of screening visit.
  2. Have a colposcopically visible lesion suspected to be high-grade that does not involve more than 75% of the cervix.
  3. Have a CIN 2/3 consensus pathology diagnosis on tissue taken from a colposcopically-directed punch biopsy.
  4. Not have evidence of cervical carcinoma on Pap smear or biopsy and not have a positive endocervical curettage.
  5. Not have atypical endometrial cells or glandular-cell atypia on Pap smear or biopsy.
  6. Have colposcopic visualization of entire squamocolumnar junction and of the entire lesion (i.e. cannot extend into canal).
  7. Not have concomitant cancer, history of malignancies, including carcinoma of the cervix, except for non-melanoma skin cancer.
  8. Be willing to sign an Institutional Review Board (IRB) approved informed consent. Minors must have the consent of a parent or legal guardian as required by local laws and regulations.
  9. Agree to use 2 acceptable forms of contraception (e.g., double-method including at least one barrier and one hormonal method).
  10. Be capable of complying with the protocol.
  11. Not have other illnesses that would put the patient at undue risk for participation in the trial or would interfere with the required clinical observations.
  12. Not have abnormalities of hematological, renal, or hepatic function as determined by clinical laboratory testing.
  13. Not have immunologic disorder such as immunodeficiency, lupus, or other chronic auto-immune disease.
  14. Not have an active systemic infection requiring treatment.
  15. Not have ongoing systemic chronic steroid therapy or immunosuppressive medication (inhalers used for treating asthma and topical steroids are permitted).
  16. Not be positive for HIV antibody.
  17. Not be pregnant or lactating.
  18. Not plan to use a cervical cap or diaphragm during the study.
  19. Not have been treated with any investigational agent within 30 days prior to randomization in this trial.
  20. Not have had prior gene therapy.
  21. Not have had an excisional or ablative procedure performed on the cervix within one year of enrollment.
  22. Be willing to consent to an excisional procedure, such as LEEP or cold-knife cone procedure, if indicated.

Please note: There may be additional inclusion/exclusion criteria. The study center will determine if patients meet all of the criteria. If patients do not qualify for the trial, study personnel will explain the reasons. If patients do qualify, study personnel will explain the trial in detail using an IRB-approved informed consent, and answer any questions. Patients can then decide if they wish to participate.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Amolimogene
1-dose amolimogene Group: Two intramuscular (IM) injections (100 micrograms ZYC101a per injection), one in each quadriceps, at Treatment Initiation. Single IM placebo injections (approximately 1 mL 0.9% sterile saline) at Weeks 3 and 6 in alternating quadriceps.
Other Names:
  • ZYC101a
Drug: Amolimogene
3-dose amolimogene Group: Two IM injections (100 micrograms ZYC101a per injection), one in each quadriceps, at Treatment Initiation. Single IM injections of 100 micrograms ZYC101a at Weeks 3 and 6 in alternating quadriceps.
Other Names:
  • ZYC101a
Experimental: 2
Drug: Amolimogene
1-dose amolimogene Group: Two intramuscular (IM) injections (100 micrograms ZYC101a per injection), one in each quadriceps, at Treatment Initiation. Single IM placebo injections (approximately 1 mL 0.9% sterile saline) at Weeks 3 and 6 in alternating quadriceps.
Other Names:
  • ZYC101a
Drug: Amolimogene
3-dose amolimogene Group: Two IM injections (100 micrograms ZYC101a per injection), one in each quadriceps, at Treatment Initiation. Single IM injections of 100 micrograms ZYC101a at Weeks 3 and 6 in alternating quadriceps.
Other Names:
  • ZYC101a
Placebo Comparator: 3
Other: Placebo
Placebo Group: Two IM placebo injections at Treatment Initiation (1 injection in each quadriceps). Single placebo injections at Weeks 3 and 6 in alternating quadriceps. Each placebo injection consists of approximately 1 mL 0.9% sterile saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cervical intraepithelial neoplasia (CIN) 2/3 resolution, defined as the histological evaluation of cervical tissue (presence or absence of CIN 2/3 as determined by pathology consensus diagnosis) at the End of Observation (EOO) period.
Time Frame: 24 weeks after enrollment.
24 weeks after enrollment.

Secondary Outcome Measures

Outcome Measure
Time Frame
Histology based on biopsy to determine the proportion of pts. w/resolution of CIN2/3. This is the same as primary efficacy variable in determination of presence or absence of CIN2/3, but excludes pts. with excisional procedure or cytology information.
Time Frame: 24 weeks after enrollment.
24 weeks after enrollment.
Histological resolution to normal to examine the proportion of patients with a histology result of "normal" versus "abnormal."
Time Frame: 24 weeks after enrollment.
24 weeks after enrollment.
Clearing or persistence of lesions based on colposcopic findings to examine the proportion of patients with "no lesion" versus "at least one lesion."
Time Frame: 24 weeks after enrollment.
24 weeks after enrollment.
Pap smear cytology.
Time Frame: 24 weeks after enrollment.
24 weeks after enrollment.
Clearing or persistence of original human papillomavirus (HPV) subtype as determined by HPV typing to present the number and percent of patients with absence of all HPV.
Time Frame: 24 weeks after enrollment.
24 weeks after enrollment.

Collaborators and Investigators

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

Sponsor

Eisai Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2005

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

December 12, 2005

First Submitted That Met QC Criteria

December 12, 2005

First Posted (Estimate)

December 13, 2005

Study Record Updates

Last Update Posted (Estimate)

May 29, 2013

Last Update Submitted That Met QC Criteria

May 21, 2013

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZYC1-004

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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