Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-02-20 @ 4:30 PM
Study NCT ID:
NCT01864759
Status:
COMPLETED
Last Update Posted:
2017-08-29
First Post:
2013-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Endovenous Administration of Oncolytic Adenovirus ICOVIR-5 in Patients With Advanced or Metastatic Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D000257', 'term': 'Adenoviridae Infections'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-28', 'studyFirstSubmitDate': '2013-05-22', 'studyFirstSubmitQcDate': '2013-05-29', 'lastUpdatePostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Viral pharmacokinetics', 'timeFrame': '1 day', 'description': 'Viremia at 0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 24 hours after endovenous injection.'}, {'measure': 'Viral pharmacodynamics', 'timeFrame': '5 days', 'description': 'Virus presence in tumors at day 5 post-administration.'}], 'primaryOutcomes': [{'measure': 'Maximum tolerated dose', 'timeFrame': '4 weeks', 'description': 'The highest dose where less than two out of three or six patients suffered dose limiting toxicity.'}], 'secondaryOutcomes': [{'measure': 'Recommended dose', 'timeFrame': '4 weeks'}, {'measure': 'Anti-tumour activity', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['melanoma', 'oncolytic', 'adenovirus', 'virotherapy', 'locally advanced', 'metastatic'], 'conditions': ['Locally Advanced or Metastatic Melanoma']}, 'referencesModule': {'references': [{'pmid': '17579575', 'type': 'BACKGROUND', 'citation': 'Cascallo M, Alonso MM, Rojas JJ, Perez-Gimenez A, Fueyo J, Alemany R. Systemic toxicity-efficacy profile of ICOVIR-5, a potent and selective oncolytic adenovirus based on the pRB pathway. Mol Ther. 2007 Sep;15(9):1607-15. doi: 10.1038/sj.mt.6300239. Epub 2007 Jun 19.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will evaluate the safety of a single endovenous infusion of ICOVIR5 in adults with locally advanced and metastatic melanoma. ICOVIR5 consists in a conditionally replicative or oncolytic adenovirus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Malignant melanoma advanced or metastatic.\n* Other than 18 years\n* Karnofsky index \\> 60 %\n* Life expectancy \\> 3 months\n* ALT/AST \\<=2.5 times the upper normal limit\n* Creatinine clearance \\>= 50 ml/min.\n* Bilirubin \\<25 umol/l\n* Alkaline phosphatase \\<= 2.5 time upper normal limit\n* Normal bone marrow function: Neutrophils \\>=1.5 E9/L, platelets \\>= 1E11/L, hemoglobin \\>= 100 g/l, Normal prothrombin time and thromboplastin time,\n* HIV negative\n* Measurable disease\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Geographical, social or psychological conditions that may impair the protocol compliance.\n* Active infections or other severe medical status.\n* History of liver disease.\n* Other or concomitant treatments for melanoma or investigational product.\n* Previous participation in studies with adenovirus.\n* Virus diseases diagnosed two weeks before inclusion.\n* Immunosuppressive concomitant treatments\n* Concomitant malignant haematological disease.\n* Patients having family members with immunodeficient status or disease\n* Patients with Li Fraumeni syndrome or germinal retinoblastoma gene defects.'}, 'identificationModule': {'nctId': 'NCT01864759', 'briefTitle': 'Phase I Endovenous Administration of Oncolytic Adenovirus ICOVIR-5 in Patients With Advanced or Metastatic Melanoma', 'organization': {'class': 'OTHER', 'fullName': "Institut Català d'Oncologia"}, 'officialTitle': 'Phase I Clinical Trial of Endovenous Administration of Conditionally Replicative Adenovirus ICOVIR-5 in Patients With Locally Advanced or Metastatic Melanoma', 'orgStudyIdInfo': {'id': 'ICOVIR5-2'}, 'secondaryIdInfos': [{'id': '2008-005694-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICOVIR5', 'description': 'ICOVIR-5 oncolytic adenovirus, single administration, endovenous, dose escalation from 1E11 vp to 1E13 vp.', 'interventionNames': ['Biological: ICOVIR-5']}], 'interventions': [{'name': 'ICOVIR-5', 'type': 'BIOLOGICAL', 'armGroupLabels': ['ICOVIR5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08908', 'city': "L'Hospitalet Del Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': "Institut Català d'Oncologia - L'Hospitalet"}], 'overallOfficials': [{'name': 'Ramon Salazar, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut Català d'Oncologia"}, {'name': 'Ramon Alemany, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "Institut Català d'Oncologia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Català d'Oncologia", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}