Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-02-26 @ 2:17 AM
Study NCT ID:
NCT00862303
Status:
UNKNOWN
Last Update Posted:
2011-03-08
First Post:
2009-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DC Vaccine Therapy Combined With Cytokine-Induced Killer Cell in Treating 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-03-07', 'studyFirstSubmitDate': '2009-03-13', 'studyFirstSubmitQcDate': '2009-03-13', 'lastUpdatePostDateStruct': {'date': '2011-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective tumor response (complete and partial response), Time to recurrence (TTR), Progression-free(PFS) and overall survival(OS) as measured by RECIST criteria.', 'timeFrame': 'every 3 months'}], 'secondaryOutcomes': [{'measure': 'Immunity as measured by T-cell functionality (immuknow assay )to the tumor. Safety as measured by NCI common toxicity table （CTC） at completion of study.', 'timeFrame': 'at screening, baseline, weeks 4 , 12 and years 1 after first vaccination, and at completion of study treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['autologous cytokine induced killer cells', 'dendritic cell', 'vaccine', 'renal cell carcinoma'], 'conditions': ['Renal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a measurable immune response in patients with renal cell carcinoma, and to evaluate the clinical effect of the regimen.', 'detailedDescription': 'The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a measurable immune response in patients with renal cell carcinoma, and to evaluate the clinical effect of the regime.\n\nPrimary\n\n1\\. Determine the clinical responses(objective response, progression-free survival, and overall survival) in patients with renal cell carcinoma treated with autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) in combination with Cytokine-Induced Killer Cell (CIK).\n\nSecondary\n\n1. Determine cellular immune response response in terms of immuknow assay, and correlate immune response with objective clinical response in patients treated with this regimen.\n2. Determine safety of multiple administrations of this regimens in these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven renal cell carcinoma\n* Age: \\> 18\n* WHO- ECOG Performance Status 0-1\n* At least one measurable tumor lesions according to the RECIST criteria.\n* Life expectancy more than 3 months\n* Written informed consent\n\nExclusion Criteria:\n\n* Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin).\n* Patients with metastatic disease in the central nervous system (CNS).\n* Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.\n* Patients with acute or chronic infection including HIV.\n* Patients who are pregnant or nursing.\n* Patients who have received antineoplastic therapy including chemotherapy or immunotherapy less than 4 weeks before beginning the trial.\n* Patients who receive corticosteroids or other immunosuppressive agents.\n* Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.'}, 'identificationModule': {'nctId': 'NCT00862303', 'briefTitle': 'DC Vaccine Therapy Combined With Cytokine-Induced Killer Cell in Treating Patients With Renal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Fuzhou General Hospital'}, 'officialTitle': 'Study of Autologous Dendritic Cells (DC) Loaded With Autologous Tumor Lysate (DC-Vaccine) in Combination With Cytokine-Induced Killer Cell (CIK) in Patients With Renal Cell Cancer', 'orgStudyIdInfo': {'id': 'fuzhough0938'}, 'secondaryIdInfos': [{'id': 'fuzhough0938'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'IL-2/IFN-α', 'interventionNames': ['Drug: IL-2/IFN-α']}, {'type': 'EXPERIMENTAL', 'label': 'DC-CIK', 'interventionNames': ['Biological: DC-CIK']}], 'interventions': [{'name': 'DC-CIK', 'type': 'BIOLOGICAL', 'otherNames': ['1'], 'description': 'Patients receive autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) by endermic injection and infusion of CIK cells.', 'armGroupLabels': ['DC-CIK']}, {'name': 'IL-2/IFN-α', 'type': 'DRUG', 'otherNames': ['2'], 'description': 'Patients receive treatment of IL-2 or IFN-α.', 'armGroupLabels': ['IL-2/IFN-α']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350025', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianming Tan, M.D and Ph.D', 'role': 'CONTACT', 'email': 'TANJM156@YAHOO.COM.CN', 'phone': '008613375918000'}], 'facility': 'Fuzhou General Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'Jianming Tan, Professor', 'role': 'CONTACT', 'email': 'TANJM156@YAHOO.COM.CN', 'phone': '008613375918000'}], 'overallOfficials': [{'name': 'Jianming Tan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fuzhou General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fuzhou General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Fuzhou General Hospital', 'oldOrganization': 'Fuzhou General Hospital'}}}}