Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2026-01-24 @ 5:02 PM
Study NCT ID:
NCT00658892
Status:
COMPLETED
Last Update Posted:
2017-05-25
First Post:
2008-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005434', 'term': 'Flow Cytometry'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}], 'ancestors': [{'id': 'D002469', 'term': 'Cell Separation'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003592', 'term': 'Cytophotometry'}, {'id': 'D005470', 'term': 'Fluorometry'}, {'id': 'D008163', 'term': 'Luminescent Measurements'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2012-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-23', 'studyFirstSubmitDate': '2008-04-12', 'studyFirstSubmitQcDate': '2008-04-12', 'lastUpdatePostDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose of B7-dendritic cell cross-linking antibody'}], 'secondaryOutcomes': [{'measure': 'Progression free survival and overall survival time'}, {'measure': 'Toxicity'}, {'measure': 'Tumor response in terms of complete or partial response at 8 weeks'}, {'measure': 'Tetramer response'}, {'measure': 'Percent change in the number of T, B, NK cells, monocytes and dendritic cells from pretreatment levels as well as the percent change in plasma concentrations of various molecular components'}]}, 'conditionsModule': {'keywords': ['recurrent melanoma', 'stage IV melanoma'], 'conditions': ['Melanoma (Skin)']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Monoclonal antibodies can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.\n\nPURPOSE: This clinical trial is studying the side effects and best dose of a monoclonal antibody in treating patients with stage IV melanoma.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the safety/toxicity of a single dose of B7-dendritic cell cross-linking antibody containing plasma in treating patients with stage IV melanoma.\n\nSecondary\n\n* Describe the immunological changes (Th1/Th2 balance, frequency of tumor specific cytotoxic T lymphocytes, and plasma cytokine profiles) in the treated patients.\n* Determine the treatment impact on tumor growth (e.g., objective response, time to progression).\n\nOUTLINE: Patients receive B7-dendritic cell cross-linking antibody IV once on day 1.\n\nPatients undergo peripheral blood collection at baseline and periodically after infusion for analysis of dendritic cell activation, cytotoxic T-lymphocyte activity, immune cell impact, and serum cytokine changes using immunophenotyping and flow cytometry.\n\nAfter completion of study treatment patients are followed every 2 months for 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed melanoma\n\n * Stage IV disease (M1a and M1b only)\n* Measurable disease according to RECIST criteria\n* HLA-A2 positive\n* Must have IgA in serum (any concentration)\n* No known standard therapy for this disease that is potentially curative or proven capable of extending life expectancy\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Hemoglobin ≥ 10.0 g/dL\n* Platelet count ≥ 75,000/mm\\^3\n* AST ≤ 5 times upper limit of normal\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Able to provide informed consent\n* Agrees to return to Mayo Clinic Rochester for follow-up\n* Agrees to participate in the mandatory translational research component of the study\n* No uncontrolled or current infection\n* No known immune deficiency\n* No B or AB blood grouping\n\nPRIOR CONCURRENT THERAPY:\n\n* More than 4 weeks since prior chemotherapy and recovered\n* More than 4 weeks since prior biologic therapy\n* No concurrent immunosuppressive therapy'}, 'identificationModule': {'nctId': 'NCT00658892', 'briefTitle': 'Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'B7-DC Xab Plasma Therapy for the Treatment of Metastatic Melanoma. A Feasibility/Pilot Study', 'orgStudyIdInfo': {'id': 'CDR0000593085'}, 'secondaryIdInfos': [{'id': 'P30CA015083', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015083', 'type': 'NIH'}, {'id': 'MC0677', 'type': 'OTHER', 'domain': 'Mayo Clinic Cancer Center'}, {'id': '06-006992', 'type': 'OTHER', 'domain': 'Mayo Clinic IRB'}, {'id': 'NCI-2009-01343', 'type': 'REGISTRY', 'domain': 'NCI-CTRP'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'B7-DC cross-linking antibody rHIgM12B7', 'type': 'BIOLOGICAL'}, {'name': 'flow cytometry', 'type': 'OTHER'}, {'name': 'immunologic technique', 'type': 'OTHER'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Svetomir Markovic, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}