Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-01-09 @ 9:49 PM
Study NCT ID:
NCT02496520
Status:
COMPLETED
Last Update Posted:
2020-02-21
First Post:
2015-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dendritic Cell-based Immunotherapy for Advanced Solid Tumours of Children and Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-19', 'studyFirstSubmitDate': '2015-06-15', 'studyFirstSubmitQcDate': '2015-07-09', 'lastUpdatePostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and type of adverse events detected in the follow up as a measure of safety and tolerability', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Event free progression, overall survival, time to progression and number and size of existent tumoral lesions as measures of clinical efficacy', 'timeFrame': '36 months'}, {'measure': 'Humoral and cellular immune response as a measure of the immunogenicity of the vaccine.', 'timeFrame': '2 weeks to 24 months'}, {'measure': 'Quality of life measured with QLQ-C30, QLQ-BN20 questionnaires.', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dendritic cell vaccination', 'sarcoma', 'central nervous system tumor', 'childhood', 'adolescent', 'immunotherapy'], 'conditions': ['Sarcoma', 'Central Nervous System Tumor']}, 'descriptionModule': {'briefSummary': 'Phase I/II, open, prospective clinical trial, historically controlled. The objective is to evaluate the safety and, as a secondary measure, the efficacy of an experimental treatment based on a cellular therapy (vaccination with autologous dendritic cells pulsed with tumor lysate) in patients affected of metastatic or relapsed sarcomas or (Central Nervous System) CNS tumors.', 'detailedDescription': 'Phase I/II, open, prospective clinical trial, historically controlled. Patients affected of metastatic or relapsed sarcomas or (Central Nervous System) CNS tumors will be included. The patients will receive standard treatment and experimental treatment based on a cellular therapy with vaccination with autologous dendritic cells pulsed with tumor lysate. The immunization schedule includes 4 monthly vaccines, 4 bimonthly and quarterly remaining vaccines. The vaccines will be administered intradermally in combination with standard treatment for each type of tumor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Diagnosis or metastatic or relapsed sarcoma or high grade central nervous system tumor\n* From 3 to 40 years\n* Surgery feasibility. In the central nervous system tumors, residual tumor after surgery must be minimal.\n\nExclusion Criteria:\n\n* Toxicity or liver, medullar, renal insufficiency that advise against participation\n* Pregnant or breast feeding women\n* Diagnosis of other tumor than basal cell squamous carcinoma of the skin or in situ cervix carcinoma\n* Immunosuppressive treatment\n* Human Immunodeficiency virus (HIV), hepatitis B, hepatitis C or syphilis infection'}, 'identificationModule': {'nctId': 'NCT02496520', 'acronym': 'DEND/TIA', 'briefTitle': 'Dendritic Cell-based Immunotherapy for Advanced Solid Tumours of Children and Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'Clinica Universidad de Navarra, Universidad de Navarra'}, 'officialTitle': 'Dendritic Cell-based Immunotherapy for Advanced Solid Tumours of Children and Young Adults', 'orgStudyIdInfo': {'id': 'DEND/TIA'}, 'secondaryIdInfos': [{'id': '2013-003632-71', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaccines with autologous dendritic cells', 'description': 'Vaccines with autologous dendritic cells', 'interventionNames': ['Biological: dendritic cells', 'Procedure: Surgery as needed by the patient´s tumor and stage', 'Drug: Chemotherapy as needed by the patient´s tumor and stage', 'Radiation: Radiation therapy as needed by the patient´s tumor and stage']}], 'interventions': [{'name': 'dendritic cells', 'type': 'BIOLOGICAL', 'description': 'vaccines with dendritic cells pulsed with tumor lysate', 'armGroupLabels': ['Vaccines with autologous dendritic cells']}, {'name': 'Surgery as needed by the patient´s tumor and stage', 'type': 'PROCEDURE', 'armGroupLabels': ['Vaccines with autologous dendritic cells']}, {'name': 'Chemotherapy as needed by the patient´s tumor and stage', 'type': 'DRUG', 'armGroupLabels': ['Vaccines with autologous dendritic cells']}, {'name': 'Radiation therapy as needed by the patient´s tumor and stage', 'type': 'RADIATION', 'armGroupLabels': ['Vaccines with autologous dendritic cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'University Clinic of Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}], 'overallOfficials': [{'name': 'Ana Patiño-García, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CUN'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinica Universidad de Navarra, Universidad de Navarra', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}