Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-03-01 @ 9:46 AM
Study NCT ID:
NCT01924156
Status:
UNKNOWN
Last Update Posted:
2016-02-22
First Post:
2013-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DC Vaccine Combined With CIK Cells in Patients With Renal Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-18', 'studyFirstSubmitDate': '2013-08-14', 'studyFirstSubmitQcDate': '2013-08-15', 'lastUpdatePostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'objective tumor response (CR+PR) as measured by RECIST criteria', 'timeFrame': '4 weeks after DC/CIK treatment'}], 'secondaryOutcomes': [{'measure': 'number of participants with adverse events', 'timeFrame': '3 days within DC/CIK treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Renal Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '24720900', 'type': 'DERIVED', 'citation': 'Wang D, Zhang B, Gao H, Ding G, Wu Q, Zhang J, Liao L, Chen H. Clinical research of genetically modified dendritic cells in combination with cytokine-induced killer cell treatment in advanced renal cancer. BMC Cancer. 2014 Apr 10;14:251. doi: 10.1186/1471-2407-14-251.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells (DC) vaccine combined with cytokine-induced killer (CIK) cells in patients with renal cell carcinoma. Experimental recombinant adenovirus-transfected DC, which engineered to express MUC1 and Survivin are used for DC-based immunotherapy. Based on the results of our previously performed preclinical study with DC vaccine combined with CIK cells, the investigators plan to perform the clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\>18 years at time of consent\n* Histopathologically confirmed diagnosis of renal cell carcinoma\n* Received standardized treatment of renal cell carcinoma\n* Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks\n* KPS (Karnofsky performance scale) \\>60\n* Patient's written informed consent\n* Predicted survival \\>3 months\n* No severe viral or bacterial infections\n\nExclusion Criteria:\n\n* Receiving chemotherapy, radiotherapy or other therapy\n* Patients with other malignancies and infectious diseases\n* Pregnant and breast-feeding patient\n* Currently participating in another clinical trial\n* Unfit for participating in this clinical trial in investigators' opinions"}, 'identificationModule': {'nctId': 'NCT01924156', 'briefTitle': 'DC Vaccine Combined With CIK Cells in Patients With Renal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Hospital to Academy of Military Medical Sciences'}, 'officialTitle': 'Safety and Therapeutic Efficacy of DC Vaccine Combined With Cytokine-induced Killer Cells in Patients With Renal Cell Carcinoma: a Phase I/II Study', 'orgStudyIdInfo': {'id': '307-CTC-DC/CIK-RCC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'adenovirus-transfected DC + CIK', 'description': 'adenovirus-transfected autologous DC vaccine plus CIK cells', 'interventionNames': ['Biological: adenovirus-transfected DC + CIK']}], 'interventions': [{'name': 'adenovirus-transfected DC + CIK', 'type': 'BIOLOGICAL', 'description': 'adenovirus-transfected DC vaccine plus CIK cells', 'armGroupLabels': ['adenovirus-transfected DC + CIK']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100071', 'city': 'Beijing', 'country': 'China', 'facility': 'Department of Hematopoietic Stem Cell Transplantation', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Hu Chen, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Hospital to Academy of Military Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Affiliated Hospital to Academy of Military Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}