Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2025-12-28 @ 3:16 PM
Study NCT ID:
NCT01844661
Status:
COMPLETED
Last Update Posted:
2016-02-19
First Post:
2013-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Repeated Infusion of CELYVIR in Children and Adults With Metastatic and Refractory Tumors.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-18', 'studyFirstSubmitDate': '2013-04-29', 'studyFirstSubmitQcDate': '2013-04-29', 'lastUpdatePostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse effects after intravenous infusions', 'timeFrame': '48 hours after each infusion', 'description': 'We will record any sign or symptom that could be related to the infusion of Celyvir.'}], 'secondaryOutcomes': [{'measure': 'Clinical outcome', 'timeFrame': 'Up to 2 months after the last infusion', 'description': 'Clinical outcome will be labelled as complete response, partial response, stable disease or disease progression.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mesenchymal stem cells', 'Oncolytic adenovirus'], 'conditions': ['Children', 'Solid Tumors', 'Metastases']}, 'referencesModule': {'references': [{'pmid': '33737338', 'type': 'DERIVED', 'citation': 'Morales-Molina A, Gambera S, Leo A, Garcia-Castro J. Combination immunotherapy using G-CSF and oncolytic virotherapy reduces tumor growth in osteosarcoma. J Immunother Cancer. 2021 Mar;9(3):e001703. doi: 10.1136/jitc-2020-001703.'}, {'pmid': '32053771', 'type': 'DERIVED', 'citation': 'Ruano D, Lopez-Martin JA, Moreno L, Lassaletta A, Bautista F, Andion M, Hernandez C, Gonzalez-Murillo A, Melen G, Alemany R, Madero L, Garcia-Castro J, Ramirez M. First-in-Human, First-in-Child Trial of Autologous MSCs Carrying the Oncolytic Virus Icovir-5 in Patients with Advanced Tumors. Mol Ther. 2020 Apr 8;28(4):1033-1042. doi: 10.1016/j.ymthe.2020.01.019. Epub 2020 Jan 21.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will evaluate the safety of weekly infusions (n=6) of CELYVIR in children and adults with metastatic and refractory solid tumors. CELYVIR consists in bone marrow-derived autologous mesenchymal stem cells (MSCs) infected with ICOVIR5, an oncolytic adenovirus. In addition to data on toxicities the investigators will evaluate clinical response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children: Up to 18 yrs. Refractory to at least 2 previous therapy lines. Life expectancy more than 6 months. Measurable disease.\n* Adults: 18-75 yrs. Refractory to at least 2 previous therapy lines. ECOG (Eastern Cooperative Oncology Group) \\<2. Measurable disease.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Central Nervous System metastasis.\n* Experimental therapy during the previous month.\n* Chemotherapy less than 3 weeks previous.\n* Any organ functionally impaired.\n* Concurrent infectious disease.'}, 'identificationModule': {'nctId': 'NCT01844661', 'briefTitle': 'Safety and Efficacy of Repeated Infusion of CELYVIR in Children and Adults With Metastatic and Refractory Tumors.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Infantil Universitario Niño Jesús, Madrid, Spain'}, 'officialTitle': 'Phase 1 Trial of Celyvir in Children and Adults With Metastatic and Refractory Solid Tumors.', 'orgStudyIdInfo': {'id': 'EudraCT2008-000364-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CELYVIR', 'description': 'Patients will received weekly (n=6) IV infusion of Celyvir.', 'interventionNames': ['Biological: CELYVIR']}], 'interventions': [{'name': 'CELYVIR', 'type': 'BIOLOGICAL', 'otherNames': ['Bone marrow-derived autologous mesenchymal stem cells infected with ICOVIR5, an oncolytic adenovirus.'], 'armGroupLabels': ['CELYVIR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28009', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Niño Jesús', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Manuel Ramírez, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Niño Jesús'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Infantil Universitario Niño Jesús, Madrid, Spain', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto de Salud Carlos III', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Manuel Ramírez, MD PhD', 'investigatorAffiliation': 'Hospital Infantil Universitario Niño Jesús, Madrid, Spain'}}}}