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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

Phase 2/Phase 3
13 Years
25 Years
Not Enrolling
Uterine Cervical Dysplasia

Thank you

Trial Information

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

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

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.

Type of Study:


Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

24 weeks after enrollment.

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2005

Completion Date:

May 2009

Related Keywords:

  • Uterine Cervical Dysplasia
  • cervical lesions
  • cervical dysplasia
  • Human papilloma virus
  • abnormal Pap
  • High-grade cervical intraepithelial lesions (CIN 2/3)
  • Uterine Cervical Dysplasia
  • Cervical Intraepithelial Neoplasia



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