Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-01-13 @ 3:26 AM
Study NCT ID:
NCT00075569
Status:
COMPLETED
Last Update Posted:
2018-05-21
First Post:
2004-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SGN-00101 Immunotherapy in Treating Patients With Grade III Cervical Intraepithelial Neoplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-01', 'completionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-17', 'studyFirstSubmitDate': '2004-01-09', 'studyFirstSubmitQcDate': '2004-01-11', 'lastUpdatePostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of regression', 'timeFrame': '4 months after completion of treatment'}, {'measure': 'Toxicity', 'timeFrame': '4 months after completion of treatment'}]}, 'conditionsModule': {'keywords': ['cervical cancer', 'cervical intraepithelial neoplasia grade 3'], 'conditions': ['Cervical Cancer', 'Precancerous Condition']}, 'referencesModule': {'references': [{'pmid': '17586030', 'type': 'RESULT', 'citation': 'Einstein MH, Kadish AS, Burk RD, Kim MY, Wadler S, Streicher H, Goldberg GL, Runowicz CD. Heat shock fusion protein-based immunotherapy for treatment of cervical intraepithelial neoplasia III. Gynecol Oncol. 2007 Sep;106(3):453-60. doi: 10.1016/j.ygyno.2007.04.038. Epub 2007 Jun 22.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer or to treat early cancer. SGN-00101 may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia.\n\nPURPOSE: This phase II trial is studying how well SGN-00101 immunotherapy works in preventing cervical cancer in patients with grade III cervical intraepithelial neoplasia.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the rate of regression at 4-7 months in patients with grade III cervical intraepithelial neoplasia (CIN III) treated with SGN-00101 immunotherapy.\n* Compare the rate of regression at 4-7 months with expected outcome in patients immunized with this vaccine.\n* Determine the toxic effects and recovery from possible toxic effects of this vaccine in these patients.\n\nSecondary\n\n* Determine induction of cell-mediated immune responses against human papillomavirus (HPV) E7 peptides before and after treatment in patients immunized with this vaccine\n* Correlate regression of disease with enhanced immunologic responses in patients immunized with this vaccine.\n* Correlate seropositivity of HPV-16 virus-like particles (VLP16) with vaccine-induced regression of CIN III in patients immunized with this vaccine.\n* Determine the efficacy of this vaccine in patients whose CIN III is associated with HPV-16 infection vs other HPV types.\n\nOUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment groups.\n\nAll patients receive SGN-00101 subcutaneously once monthly on months 1-3 (for a total of 3 vaccinations) in the absence of disease progression or unacceptable toxicity.\n\n* Group 1: Four months after the first vaccination, patients undergo therapeutic and diagnostic loop electrosurgical excision procedure (LEEP) or core biopsy.\n* Group 2: Six months after the first vaccination, patients undergo therapeutic and diagnostic LEEP or core biopsy.\n\nPatients in group 1 are followed at 12 months and patients in group 2 are followed at 14 months after the first vaccination.\n\nPROJECTED ACCRUAL: A total of 66 patients (36 for group 1 and 30 for group 2) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed grade III cervical intraepithelial neoplasia (CIN III) with colposcopically visible cervical lesions\n* No positive endocervical curettage or inadequate colposcopy at the time of initial cervical biopsy\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* WBC at least 3,500/mm\\^3\n* Lymphocyte count at least 500/mm\\^3\n* Platelet count at least 150,000/mm\\^3\n* Hemoglobin at least 10 g/dL\n* No significant hematologic disease that is uncontrolled with standard therapy\n\nHepatic\n\n* Bilirubin no greater than 2 mg/dL\n* Liver enzymes no greater than 2.5 times normal\n* No significant hepatic disease that is uncontrolled with standard therapy\n\nRenal\n\n* Creatinine no greater than 2 mg/dL\n* No significant renal disease that is uncontrolled with standard therapy\n\nCardiovascular\n\n* No significant cardiovascular disease that is uncontrolled with standard therapy\n\nPulmonary\n\n* No significant respiratory disease that is uncontrolled with standard therapy\n* No history of asthma\n\nImmunologic\n\n* HIV negative\n* No clinical evidence of immunosuppression\n* No autoimmune disease\n* No history of allergic reactions attributed to compounds of similar chemical or biological activity as those used in this study\n* No history of a positive purified protein derivative (PPD) or Tine test\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Good health based upon the results of a medical history, physical examination, vital signs, and laboratory profile\n* No uncontrolled chronic disease\n\n * Chronic disease requiring medication is allowed provided the patient is not taking immunosuppressive drugs\n* No significant endocrine (e.g., thyroid or diabetes), neurologic, gastrointestinal, or dermatologic disease that is uncontrolled with standard therapy\n* No other underlying or unstable disease that would be exacerbated by the study treatment\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No prior BCG vaccination\n* No other concurrent vaccine therapy\n\nChemotherapy\n\n* No concurrent chemotherapy\n\nEndocrine therapy\n\n* More than 30 days since prior oral or parenteral glucocorticoid steroid\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified\n\nOther\n\n* More than 30 days since prior participation in another investigational study\n* No concurrent cytotoxic therapy\n* No other concurrent investigational agents\n* No other concurrent investigational or commercial agents or therapies intended to treat CIN'}, 'identificationModule': {'nctId': 'NCT00075569', 'briefTitle': 'SGN-00101 Immunotherapy in Treating Patients With Grade III Cervical Intraepithelial Neoplasia', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein College of Medicine'}, 'officialTitle': 'SGN-00101 (HspE7) Immunotherapy Of CIN III', 'orgStudyIdInfo': {'id': '03-10-251'}, 'secondaryIdInfos': [{'id': 'AECOM-0309225', 'type': 'OTHER', 'domain': 'Albert Einstein College of Medicine'}, {'id': 'NCI-5850', 'type': 'OTHER_GRANT', 'domain': 'National Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 month follow-up', 'description': '3 monthly subcutaneous vaccinations with 500 microg of HspE7 followed by monthly colposcopic follow-up for 1 month; followed by LEEP or cone biopsy', 'interventionNames': ['Biological: HspE7']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 month follow-up', 'description': '3 monthly subcutaneous vaccinations with 500 microg of HspE7 followed by monthly colposcopic follow-up for 2 months; followed by LEEP or cone biopsy', 'interventionNames': ['Biological: HspE7']}], 'interventions': [{'name': 'HspE7', 'type': 'BIOLOGICAL', 'otherNames': ['SGN-00101'], 'description': '500 micrograms of SGN-00101 (HspE7, Nventa, San Diego, CA) is a novel therapeutic vaccine consisting of a fusion protein containing an M. bovis BCG heat shock protein (Hsp65) covalently linked to the entire sequence of HPV 16 E7.', 'armGroupLabels': ['1 month follow-up', '2 month follow-up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Weill Cornell Cancer Center at Cornell University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein Cancer Center at Albert Einstein College of Medicine', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Carolyn D. Runowicz, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'UConn Health'}, {'name': 'Mark H. Einstein, MD, MS', 'affiliation': 'Albert Einstein College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}