A Study of Amolimogene (ZYC101a) in Patients With High Grade Cervical Intraepithelial Lesions of the Uterine Cervix
NCT ID: NCT00264732
Last Updated: 2013-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
251 participants
INTERVENTIONAL
2005-07-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
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.
2
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.
3
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
13 Years
25 Years
FEMALE
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Locations
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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
Tidewater Clinical Research
Virginia Beach, Virginia, United States
Countries
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References
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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. doi: 10.1086/382956. Epub 2004 Mar 30.
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. doi: 10.1097/01.AOG.0000110246.93627.17.
Other Identifiers
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ZYC1-004
Identifier Type: -
Identifier Source: org_study_id
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