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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Uterine Cervical Dysplasia

In brief

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.

Key facts

Study ID: NCT00264732
Run by: Eisai Inc.
People needed: 251
Starts: 2005-07-01
Expected to finish: 2009-05-01
Last updated by the study team: 2013-05-29

Who can join

Age: 13 and older, up to 25. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

To be considered for enrollment, patients must:
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.
Have a colposcopically visible lesion suspected to be high-grade that does not involve more than 75% of the cervix.
Have a CIN 2/3 consensus pathology diagnosis on tissue taken from a colposcopically-directed punch biopsy.
Not have evidence of cervical carcinoma on Pap smear or biopsy and not have a positive endocervical curettage.
Not have atypical endometrial cells or glandular-cell atypia on Pap smear or biopsy.
Have colposcopic visualization of entire squamocolumnar junction and of the entire lesion (i.e. cannot extend into canal).
Not have concomitant cancer, history of malignancies, including carcinoma of the cervix, except for non-melanoma skin cancer.
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.
Agree to use 2 acceptable forms of contraception (e.g., double-method including at least one barrier and one hormonal method).
Be capable of complying with the protocol.
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.
Not have abnormalities of hematological, renal, or hepatic function as determined by clinical laboratory testing.
Not have immunologic disorder such as immunodeficiency, lupus, or other chronic auto-immune disease.
Not have an active systemic infection requiring treatment.
Not have ongoing systemic chronic steroid therapy or immunosuppressive medication (inhalers used for treating asthma and topical steroids are permitted).
Not be positive for HIV antibody.
Not be pregnant or lactating.
Not plan to use a cervical cap or diaphragm during the study.
Not have been treated with any investigational agent within 30 days prior to randomization in this trial.
Not have had prior gene therapy.
Not have had an excisional or ablative procedure performed on the cervix within one year of enrollment.
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.

Where it is running

University of Alabama — Birmingham, Alabama, United States
Arizona Wellness Center for Women/Precision Trials, LLC — Phoenix, Arizona, United States
University of Arizona — Tucson, Arizona, United States
Arrowhead Regional Medical Center — Colton, California, United States
The Center for Advanced Research and Education, Inc. — Palm Springs, California, United States
Medical Center for Clinical Research — San Diego, California, United States
Physicians Research Options, LC — Lakewood, Colorado, United States
Visions Clinical Research — Boynton Beach, Florida, United States
University of Florida, Miami — Miami, Florida, United States
Physician Care Clinical Research — Sarasota, Florida, United States
Insignia Clinical Research — Tampa, Florida, United States
Comprehensive Clinical Trials LLC — West Palm Beach, Florida, United States
Medical College of Georgia, Department of Family Medicine — Augusta, Georgia, United States
Rosemark Women's Care Specialists — Idaho Falls, Idaho, United States
University of Minnesota — Minneapolis, Minnesota, United States
Centennial Hills OB-GYN Associaties — North Las Vegas, Nevada, United States
Southwest Clinical Research — Albuquerque, New Mexico, United States
Lyndhurst Gynecologic Associates — Winston-Salem, North Carolina, United States
The University of Oklahoma Health Sciences Center, Center for Research in Women's Health — Oklahoma City, Oklahoma, United States
Temple Center for Women's Health — Philadelphia, Pennsylvania, United States
Sarah Cannon Research — Memphis, Tennessee, United States
Michael Altenbern, MD — Nashville, Tennessee, United States
UT Southwestern Medical Center at Dallas — Dallas, Texas, United States
Physicians' Research Options — Pleasant Grove, Utah, United States
Physicians' Research Options, LLC — Sandy City, Utah, United States

Full record on ClinicalTrials.gov

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