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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00264732
Other study ID # ZYC1-004
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received December 12, 2005
Last updated May 21, 2013
Start date July 2005
Est. completion date May 2009

Study information

Verified date May 2012
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 251
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Female
Age group 13 Years to 25 Years
Eligibility 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 Design

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


Intervention

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.
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:
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

Crum CP, Beach KJ, Hedley ML, Yuan L, Lee KR, Wright TC, Urban RG. Dynamics of human papillomavirus infection between biopsy and excision of cervical intraepithelial neoplasia: results from the ZYC101a protocol. J Infect Dis. 2004 Apr 15;189(8):1348-54. Epub 2004 Mar 30. — View Citation

Garcia F, Petry KU, Muderspach L, Gold MA, Braly P, Crum CP, Magill M, Silverman M, Urban RG, Hedley ML, Beach KJ. ZYC101a for treatment of high-grade cervical intraepithelial neoplasia: a randomized controlled trial. Obstet Gynecol. 2004 Feb;103(2):317-26. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 24 weeks after enrollment. No
Secondary 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. 24 weeks after enrollment. No
Secondary Histological resolution to normal to examine the proportion of patients with a histology result of "normal" versus "abnormal." 24 weeks after enrollment. No
Secondary Clearing or persistence of lesions based on colposcopic findings to examine the proportion of patients with "no lesion" versus "at least one lesion." 24 weeks after enrollment. No
Secondary Pap smear cytology. 24 weeks after enrollment. No
Secondary 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. 24 weeks after enrollment. No
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