Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-25 @ 7:21 PM
Study NCT ID:
NCT00264732
Status:
COMPLETED
Last Update Posted:
2013-05-29
First Post:
2005-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Amolimogene (ZYC101a) in Patients With High Grade Cervical Intraepithelial Lesions of the Uterine Cervix
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C482279', 'term': 'ZYC101a'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 251}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'dispFirstSubmitDate': '2013-05-21', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-21', 'studyFirstSubmitDate': '2005-12-12', 'dispFirstSubmitQcDate': '2013-05-21', 'studyFirstSubmitQcDate': '2005-12-12', 'dispFirstPostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': '24 weeks after enrollment.'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': '24 weeks after enrollment.'}, {'measure': 'Histological resolution to normal to examine the proportion of patients with a histology result of "normal" versus "abnormal."', 'timeFrame': '24 weeks after enrollment.'}, {'measure': 'Clearing or persistence of lesions based on colposcopic findings to examine the proportion of patients with "no lesion" versus "at least one lesion."', 'timeFrame': '24 weeks after enrollment.'}, {'measure': 'Pap smear cytology.', 'timeFrame': '24 weeks after enrollment.'}, {'measure': '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.', 'timeFrame': '24 weeks after enrollment.'}]}, 'conditionsModule': {'keywords': ['cervical lesions', 'cervical dysplasia', 'Human papilloma virus', 'abnormal Pap', 'High-grade cervical intraepithelial lesions (CIN 2/3)'], 'conditions': ['Uterine Cervical Dysplasia']}, 'referencesModule': {'references': [{'pmid': '15073670', 'type': 'BACKGROUND', 'citation': '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': '14754702', 'type': 'BACKGROUND', '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. doi: 10.1097/01.AOG.0000110246.93627.17.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This is a double-blind study, so neither the patient not the doctor will know which treatment has been assigned.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTo be considered for enrollment, patients must:\n\n1. 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.\n2. Have a colposcopically visible lesion suspected to be high-grade that does not involve more than 75% of the cervix.\n3. Have a CIN 2/3 consensus pathology diagnosis on tissue taken from a colposcopically-directed punch biopsy.\n4. Not have evidence of cervical carcinoma on Pap smear or biopsy and not have a positive endocervical curettage.\n5. Not have atypical endometrial cells or glandular-cell atypia on Pap smear or biopsy.\n6. Have colposcopic visualization of entire squamocolumnar junction and of the entire lesion (i.e. cannot extend into canal).\n7. Not have concomitant cancer, history of malignancies, including carcinoma of the cervix, except for non-melanoma skin cancer.\n8. 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.\n9. Agree to use 2 acceptable forms of contraception (e.g., double-method including at least one barrier and one hormonal method).\n10. Be capable of complying with the protocol.\n11. 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.\n12. Not have abnormalities of hematological, renal, or hepatic function as determined by clinical laboratory testing.\n13. Not have immunologic disorder such as immunodeficiency, lupus, or other chronic auto-immune disease.\n14. Not have an active systemic infection requiring treatment.\n15. Not have ongoing systemic chronic steroid therapy or immunosuppressive medication (inhalers used for treating asthma and topical steroids are permitted).\n16. Not be positive for HIV antibody.\n17. Not be pregnant or lactating.\n18. Not plan to use a cervical cap or diaphragm during the study.\n19. Not have been treated with any investigational agent within 30 days prior to randomization in this trial.\n20. Not have had prior gene therapy.\n21. Not have had an excisional or ablative procedure performed on the cervix within one year of enrollment.\n22. Be willing to consent to an excisional procedure, such as LEEP or cold-knife cone procedure, if indicated.\n\nPlease 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.'}, 'identificationModule': {'nctId': 'NCT00264732', 'briefTitle': 'A Study of Amolimogene (ZYC101a) in Patients With High Grade Cervical Intraepithelial Lesions of the Uterine Cervix', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ZYC1-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Amolimogene']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: Amolimogene']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Amolimogene', 'type': 'DRUG', 'otherNames': ['ZYC101a'], 'description': '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.', 'armGroupLabels': ['1']}, {'name': 'Amolimogene', 'type': 'DRUG', 'otherNames': ['ZYC101a'], 'description': '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.', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Wellness Center for Women/Precision Trials, LLC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92324', 'city': 'Colton', 'state': 'California', 'country': 'United States', 'facility': 'Arrowhead Regional Medical Center', 'geoPoint': {'lat': 34.0739, 'lon': -117.31365}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'The Center for Advanced Research and Education, Inc.', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Medical Center for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Physicians Research Options, LC', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '33472', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Visions Clinical Research', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida, Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Physician Care Clinical Research', 'geoPoint': {'lat': 27.33643, 'lon': 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'state': 'Nevada', 'country': 'United States', 'facility': 'Centennial Hills OB-GYN Associaties', 'geoPoint': {'lat': 36.19886, 'lon': -115.1175}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Southwest Clinical Research', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lyndhurst Gynecologic Associates', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': "The University of Oklahoma Health Sciences Center, Center for Research in Women's Health", 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Temple Center for Women's Health", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '33437', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Michael Altenbern, MD', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center at Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84062', 'city': 'Pleasant Grove', 'state': 'Utah', 'country': 'United States', 'facility': "Physicians' Research Options", 'geoPoint': {'lat': 40.36412, 'lon': -111.73854}}, {'zip': '84070', 'city': 'Sandy City', 'state': 'Utah', 'country': 'United States', 'facility': "Physicians' Research Options, LLC", 'geoPoint': {'lat': 40.59161, 'lon': -111.8841}}, {'zip': '23456', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Tidewater Clinical Research', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}