Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 4:15 AM
Study NCT ID:
NCT00243594
Status:
COMPLETED
Last Update Posted:
2009-02-19
First Post:
2005-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dendritic Cell Vaccination in Melanoma Patients Scheduled for Regional Lymph Node Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'lastUpdateSubmitDate': '2009-02-18', 'studyFirstSubmitDate': '2005-10-21', 'studyFirstSubmitQcDate': '2005-10-21', 'lastUpdatePostDateStruct': {'date': '2009-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immune response', 'timeFrame': 'during the first 10 years'}, {'measure': 'Migration efficacy', 'timeFrame': 'during the first 1-2 years'}], 'secondaryOutcomes': [{'measure': 'Clinical response', 'timeFrame': 'during the first 10 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dendritic cells', 'Immunotherapy', 'Vaccination', 'Melanoma', 'Peptides', 'MRI', 'Scintigraphy', 'Immune response'], 'conditions': ['Melanoma Stage III or IV']}, 'referencesModule': {'references': [{'pmid': '16110035', 'type': 'BACKGROUND', 'citation': 'de Vries IJ, Bernsen MR, Lesterhuis WJ, Scharenborg NM, Strijk SP, Gerritsen MJ, Ruiter DJ, Figdor CG, Punt CJ, Adema GJ. Immunomonitoring tumor-specific T cells in delayed-type hypersensitivity skin biopsies after dendritic cell vaccination correlates with clinical outcome. J Clin Oncol. 2005 Aug 20;23(24):5779-87. doi: 10.1200/JCO.2005.06.478.'}, {'pmid': '15477299', 'type': 'BACKGROUND', 'citation': 'Lesterhuis WJ, de Vries IJ, Adema GJ, Punt CJ. Dendritic cell-based vaccines in cancer immunotherapy: an update on clinical and immunological results. Ann Oncol. 2004;15 Suppl 4:iv145-51. doi: 10.1093/annonc/mdh919. No abstract available.'}, {'pmid': '15122249', 'type': 'BACKGROUND', 'citation': 'Figdor CG, de Vries IJ, Lesterhuis WJ, Melief CJ. Dendritic cell immunotherapy: mapping the way. Nat Med. 2004 May;10(5):475-80. doi: 10.1038/nm1039.'}, {'pmid': '14613986', 'type': 'BACKGROUND', 'citation': 'de Vries IJ, Lesterhuis WJ, Scharenborg NM, Engelen LP, Ruiter DJ, Gerritsen MJ, Croockewit S, Britten CM, Torensma R, Adema GJ, Figdor CG, Punt CJ. Maturation of dendritic cells is a prerequisite for inducing immune responses in advanced melanoma patients. Clin Cancer Res. 2003 Nov 1;9(14):5091-100.'}, {'pmid': '12517769', 'type': 'BACKGROUND', 'citation': 'De Vries IJ, Krooshoop DJ, Scharenborg NM, Lesterhuis WJ, Diepstra JH, Van Muijen GN, Strijk SP, Ruers TJ, Boerman OC, Oyen WJ, Adema GJ, Punt CJ, Figdor CG. Effective migration of antigen-pulsed dendritic cells to lymph nodes in melanoma patients is determined by their maturation state. Cancer Res. 2003 Jan 1;63(1):12-7.'}, {'pmid': '12218781', 'type': 'BACKGROUND', 'citation': 'de Vries IJ, Eggert AA, Scharenborg NM, Vissers JL, Lesterhuis WJ, Boerman OC, Punt CJ, Adema GJ, Figdor CG. Phenotypical and functional characterization of clinical grade dendritic cells. J Immunother. 2002 Sep-Oct;25(5):429-38. doi: 10.1097/00002371-200209000-00007.'}, {'pmid': '15766677', 'type': 'BACKGROUND', 'citation': 'Adema GJ, de Vries IJ, Punt CJ, Figdor CG. Migration of dendritic cell based cancer vaccines: in vivo veritas? Curr Opin Immunol. 2005 Apr;17(2):170-4. doi: 10.1016/j.coi.2005.01.004.'}, {'pmid': '16258544', 'type': 'BACKGROUND', 'citation': 'de Vries IJ, Lesterhuis WJ, Barentsz JO, Verdijk P, van Krieken JH, Boerman OC, Oyen WJ, Bonenkamp JJ, Boezeman JB, Adema GJ, Bulte JW, Scheenen TW, Punt CJ, Heerschap A, Figdor CG. Magnetic resonance tracking of dendritic cells in melanoma patients for monitoring of cellular therapy. Nat Biotechnol. 2005 Nov;23(11):1407-13. doi: 10.1038/nbt1154. Epub 2005 Oct 30.'}, {'pmid': '23382117', 'type': 'DERIVED', 'citation': 'Aarntzen EH, Srinivas M, Bonetto F, Cruz LJ, Verdijk P, Schreibelt G, van de Rakt M, Lesterhuis WJ, van Riel M, Punt CJ, Adema GJ, Heerschap A, Figdor CG, Oyen WJ, de Vries IJ. Targeting of 111In-labeled dendritic cell human vaccines improved by reducing number of cells. Clin Cancer Res. 2013 Mar 15;19(6):1525-33. doi: 10.1158/1078-0432.CCR-12-1879. Epub 2013 Feb 4.'}], 'seeAlsoLinks': [{'url': 'http://www.umcn.nl', 'label': 'Home page of the Radboud University Nijmegen Medical Centre'}, {'url': 'http://www.ncmls.nl/', 'label': 'Website of the department of Tumor Immunology of the Nijmegen Centre for Molecular Life Sciences of the Radboud University Nijmegen Medical Centre'}]}, 'descriptionModule': {'briefSummary': 'Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As such they are currently used in clinical vaccination protocols in cancer patients, and both immunological and clinical responses have been observed. For these therapies accurate delivery to target organs is essential. Correct delivery and subsequent migration of vaccinated DCs to regional lymph nodes is of paramount importance for effective stimulation of the immune system. Currently it is not known what the best route of administration is for DC vaccines.\n\nUsing magnetically labeled DCs, we investigate the potential of MRI cell tracking to monitor DC therapy. This is investigated in stage III/IV melanoma patients in whom a regional lymph node dissection is scheduled. Autologous monocyte-derived DCs are labeled with the clinically approved superparamagnetic iron oxide (SPIO) formulation Endorem and 111In-oxine and injected either in the skin or directly in lymph nodes under ultrasound guidance. Two days after vaccination patients are monitored with scintigraphy and MR imaging. Lymph nodes are then resected. Subsequently patients receive 3 more vaccination with DCs. During and after therapy immune responses against the used melanoma peptides are monitored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nHistologically documented evidence of melanoma\n\nStage III-IV melanoma according to the 2001 AJCC criteria\n\nRadical lymph node dissection planned, either with curative (stage III) or palliative (stage IV) intent\n\nMelanoma expressing gp100 (compulsory) and tyrosinase (non-compulsory)\n\nHLA-A2.1 phenotype according to lymphocyte HLA typing\n\nECOG performance status 0-1, life expectancy \\> 3 months\n\nAge 18-75 years\n\nInterval since last prior chemotherapy, immunotherapy or radiotherapy at least 4 weeks, no residual toxicity of prior treatment.\n\nWBC \\> 3.0 x 109/l, lymphocytes \\> 0.8 x 109/l, platelets \\> 100 x 109/l, serum creatinine \\< 150 μmol/l, serum bilirubin \\< 25 μmol/l\n\nWritten informed consent\n\nExpected adequacy of follow-up\n\nExclusion criteria:\n\nNo clinical signs of CNS metastases, in patients with a clinical suspicion of other metastases diagnostic tests should be performed to exclude this.\n\nNo concomitant use of corticosteroids or other immunosuppressive agents\n\nNo history of second malignancy within the last 5 years. Adequately treated basal carcinoma of skin or carcinoma in situ of cervix is acceptable within this period\n\nNo serious concomitant disease, no active infections. No autoimmune disease or organ allografts, no clinical suspicion of HIV or Hepatitis B\n\nNo contra-indications for MRI-scanning: claustrophobia, pacemaker or pacemaker threads, cerebral clips or artificial heartvalves, internal hearing prosthesis No known allergy to shell fish (contains KLH)\n\nNo pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT00243594', 'briefTitle': 'Dendritic Cell Vaccination in Melanoma Patients Scheduled for Regional Lymph Node Dissection', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Active Immunization of Patients With Stage III and IV Melanoma in Whom a Regional Lymph Node Dissection is Planned, With Peptide-Pulsed Dendritic Cells: Evaluation of in Vivo Immune and Clinical Response and Migration', 'orgStudyIdInfo': {'id': '2004-3126'}, 'secondaryIdInfos': [{'id': '2004-3126'}, {'id': 'KUN99-1950'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Peptide-pulsed dendritic cells', 'type': 'BIOLOGICAL', 'description': 'peptide-pulsed dendritic cells'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500 HB', 'city': 'Nijmegen', 'state': 'PO Box 9101', 'country': 'Netherlands', 'facility': 'Radboud University Nijmegen Medical Centre', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Prof. C.J.A. Punt, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}, {'name': 'Prof. C.G. Figdor, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dutch Cancer Society', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'C.J.A. Punt, MD, PhD', 'oldOrganization': 'Radboud University Nijmegen Medical Centre'}}}}