Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT00148993
Status:
WITHDRAWN
Last Update Posted:
2011-04-08
First Post:
2005-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Allogeneic Tumor Cell Vaccination in Patients With Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C573235', 'term': 'FANG vaccine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'whyStopped': 'PI (Prof. Slavin) not longer work at Hadassah', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '1998-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-07', 'completionDateStruct': {'date': '2005-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-07', 'studyFirstSubmitDate': '2005-09-07', 'studyFirstSubmitQcDate': '2005-09-07', 'lastUpdatePostDateStruct': {'date': '2011-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigate the feasibility of anti-tumor immune response by allogeneic tumor cell vaccine using tumor cells that share MHC determinants with the patient.'}], 'secondaryOutcomes': [{'measure': 'Investigate the feasibility of immune responses against cancer cells by combining allogeneic TCV with indomethacin, cimetidine, tetanus and rIL-2.'}]}, 'conditionsModule': {'keywords': ['Tumor cell vaccine'], 'conditions': ['Metastatic Solid Tumors']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to apply allogeneic tumor cell vaccination for immunotherapy in patients with micro-metastatic disease and/or in patients at high risk disease progression. The present study will use allogeneic tumor cell lines for tumor cell vaccines that share MHC determinants with the patient aiming to overcome possible restriction of antigen presentation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with measurable metastatic disease or disease resistant to chemotherapy or with minimal residual disease at high risk to relapse.\n\nExclusion Criteria:\n\n* Karnofsky less than 60%. Unrelated condition requiring the use of any cytotoxic agents or immunosuppressive agents which may interfere with optimal immune response.'}, 'identificationModule': {'nctId': 'NCT00148993', 'briefTitle': 'Allogeneic Tumor Cell Vaccination in Patients With Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Allogeneic Tumor Cell Vaccination in Patients With Solid Tumors', 'orgStudyIdInfo': {'id': '100798-HMO-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tumor Cell Vaccine', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'The International Center for Cell Therapy & Cancer Immunotherapy (CTCI)', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'shimon slavin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The International Center for Cell Therapy & Cancer Immunotherapy (CTCI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'collaborators': [{'name': 'The International Center for Cell Therapy & Cancer Immunotherapy (CTCI)', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Shimon Slavin MD', 'oldOrganization': 'The International Center for Cell Therapy & Cancer Immunotherapy (CTCI)'}}}}