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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00264732
Recruitment Status : Completed
First Posted : December 13, 2005
Last Update Posted : May 29, 2013
Information provided by (Responsible Party):
Eisai Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Uterine Cervical Dysplasia Drug: Amolimogene Other: Placebo Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2005
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

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 Name: ZYC101a

Experimental: 2 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 Name: 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.

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]
  2. Histological resolution to normal to examine the proportion of patients with a histology result of "normal" versus "abnormal." [ Time Frame: 24 weeks after enrollment. ]
  3. 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. ]
  4. Pap smear cytology. [ Time Frame: 24 weeks after enrollment. ]
  5. 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. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   13 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00264732

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Sponsors and Collaborators
Eisai Inc.
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Responsible Party: Eisai Inc. Identifier: NCT00264732    
Other Study ID Numbers: ZYC1-004
First Posted: December 13, 2005    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: May 2012
Keywords provided by Eisai Inc.:
cervical lesions
cervical dysplasia
Human papilloma virus
abnormal Pap
High-grade cervical intraepithelial lesions (CIN 2/3)
Additional relevant MeSH terms:
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Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type