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

Eisai

Status and phase

Completed

Phase 3

Phase 2

Conditions

Uterine Cervical Dysplasia

Treatments

Drug: Amolimogene

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00264732

ZYC1-004

Details and patient eligibility

About

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.

Full description

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

Enrollment

251 patients

Sex

Female

Ages

13 to 25 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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.