Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 3:42 AM
Study NCT ID:
NCT00197860
Status:
COMPLETED
Last Update Posted:
2011-11-23
First Post:
2005-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dendritic Cell Based Therapy of 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': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-22', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2011-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary aim of the study is to evaluate tolerability and safety of the treatment.', 'timeFrame': 'weekly for the first four weeks, thereafter biweekly'}], 'secondaryOutcomes': [{'measure': 'Secondary aims: evaluation of treatment induced immune response and clinical response.', 'timeFrame': 'after 8 and 16 weeks of treatment'}]}, 'conditionsModule': {'keywords': ['dendritic cell', 'vaccine', 'renal cell carcinoma'], 'conditions': ['Advanced Renal Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '14985857', 'type': 'BACKGROUND', 'citation': 'Svane IM, Pedersen AE, Johnsen HE, Nielsen D, Kamby C, Gaarsdal E, Nikolajsen K, Buus S, Claesson MH. Vaccination with p53-peptide-pulsed dendritic cells, of patients with advanced breast cancer: report from a phase I study. Cancer Immunol Immunother. 2004 Jul;53(7):633-41. doi: 10.1007/s00262-003-0493-5. Epub 2004 Feb 25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with peptides or tumor lysate in combination with adjuvant cytokines can induce a measurable immune response in patients with metastatic renal cell carcinoma, and to evaluate the clinical effect (objective response rate) of the vaccination regime.', 'detailedDescription': 'Eligible patients receive vaccination with tumor antigen pulsed autologous monocyte-derived mature dendritic cells with a fixed interval. The dendritic cells are generated from leukapheresis products and frozen after antigen loading.\n\nHLA A2 positive patients are treated with PADRE and oncopeptide pulsed DC; survivin and telomerase peptides. HLA A2 negative patients are treated with KLH and tumorlysate pulsed DC; autologous or allogeneic. Each patient is given 6 immunizations with at least 5x106 peptide/lysate pulsed autologous DC. Vaccination 1-4 is given weekly and 4-6 at 2-week intervals. Those patients who exhibit stable disease, partial response or complete response after 6 injections will be given 4 more vaccinations at 2-week interval. The vaccine is applied by intradermal injection near the inguinal region. IL-2 2 MIU s.c. day 2-6 and Thymosin alpha 1 (Zadaxin®, SciClone) 1,6 mg s.c. twice a week are used for adjuvants. Scans and re-staging tests are performed at scheduled intervals throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven progressive metastatic or locally advanced renal cell carcinoma\n* No standard treatment indicated\n* Age: \\> 18\n* WHO-Performance Status 0-1\n* At least tone measurable tumor lesions according to the RECIST criteria.\n* Life expectancy more than 3 months\n* Acceptable CBC and blood chemistry results\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, hepatitis and tuberculosis.\n* Patients who are pregnant.\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* Baseline serum LDH greater than 4 times the upper limit of normal.\n* Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.'}, 'identificationModule': {'nctId': 'NCT00197860', 'briefTitle': 'Dendritic Cell Based Therapy of Renal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Vaccination With Autologous Dendritic Cells Pulsed With Tumor Antigens for Treatment of Patients With Renal Cell Carcinoma.A Phase I/II Study.', 'orgStudyIdInfo': {'id': 'UR0414'}}, 'armsInterventionsModule': {'interventions': [{'name': 'tumor antigen loaded autologous dendritic cells', 'type': 'BIOLOGICAL', 'description': 'DC vaccination regime consists of primary 10 intradermal injections of 1-2 weeks interval (q1w x 4 → q2w x 6). HLA-A2 positive patients are treated with survivin and telomerase peptide-pulsed dendritic cells, and HLA-A2 negative patients are treated with allogeneic tumor lysate-pulsed dendritic cells i.d. 1,6 mg Thymosin alpha 1 (Zadaxin®, SciClone) is administered s.c. twice a week and from the 2nd vaccine, 2 MIU Interleukin-2 is administered s.c. on day 2-6.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Department of Oncology, Copenhagen University Hospital, Herlev', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Inge Marie Svane, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inge Marie Svane', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Inge Marie Svane', 'investigatorAffiliation': 'Herlev Hospital'}}}}