A Study of Amolimogene (ZYC101a) in Patients With High Grade Cervical Intraepithelial Lesions of the Uterine Cervix
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
1 other identifier
interventional
251
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2005
Typical duration for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 12, 2005
CompletedFirst Posted
Study publicly available on registry
December 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedMay 29, 2013
May 1, 2012
3.8 years
December 12, 2005
May 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
24 weeks after enrollment.
Secondary Outcomes (5)
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.
Histological resolution to normal to examine the proportion of patients with a histology result of "normal" versus "abnormal."
24 weeks after enrollment.
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.
Pap smear cytology.
24 weeks after enrollment.
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.
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
PLACEBO COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (26)
University of Alabama
Birmingham, Alabama, 35205, United States
Arizona Wellness Center for Women/Precision Trials, LLC
Phoenix, Arizona, 85032, United States
University of Arizona
Tucson, Arizona, 85724, United States
Arrowhead Regional Medical Center
Colton, California, 92324, United States
The Center for Advanced Research and Education, Inc.
Palm Springs, California, 92262, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Physicians Research Options, LC
Lakewood, Colorado, 80228, United States
Visions Clinical Research
Boynton Beach, Florida, 33472, United States
University of Florida, Miami
Miami, Florida, 33136, United States
Physician Care Clinical Research
Sarasota, Florida, 34239, United States
Insignia Clinical Research
Tampa, Florida, 33613, United States
Comprehensive Clinical Trials LLC
West Palm Beach, Florida, 33409, United States
Medical College of Georgia, Department of Family Medicine
Augusta, Georgia, 30912, United States
Rosemark Women's Care Specialists
Idaho Falls, Idaho, 83404, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Centennial Hills OB-GYN Associaties
North Las Vegas, Nevada, 89030, United States
Southwest Clinical Research
Albuquerque, New Mexico, 87102, United States
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, 27103, United States
The University of Oklahoma Health Sciences Center, Center for Research in Women's Health
Oklahoma City, Oklahoma, 73104, United States
Temple Center for Women's Health
Philadelphia, Pennsylvania, 19140, United States
Sarah Cannon Research
Memphis, Tennessee, 38120, United States
Michael Altenbern, MD
Nashville, Tennessee, 33437, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
Physicians' Research Options
Pleasant Grove, Utah, 84062, United States
Physicians' Research Options, LLC
Sandy City, Utah, 84070, United States
Tidewater Clinical Research
Virginia Beach, Virginia, 23456, United States
Related 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. doi: 10.1086/382956. Epub 2004 Mar 30.
PMID: 15073670BACKGROUNDGarcia 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.
PMID: 14754702BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2005
First Posted
December 13, 2005
Study Start
July 1, 2005
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
May 29, 2013
Record last verified: 2012-05