Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT00099593
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2004-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunization Against Tumor Cells in Sezary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D012751', 'term': 'Sezary Syndrome'}, {'id': 'D009182', 'term': 'Mycosis Fungoides'}], 'ancestors': [{'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-12', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2004-12-17', 'studyFirstSubmitQcDate': '2004-12-17', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical response (clearance of skin lesions, clinical and radiographic improvement in lymphadenopathy)'}], 'secondaryOutcomes': [{'measure': 'Biological response'}, {'measure': 'Survival'}, {'measure': 'Activities of daily living'}, {'measure': 'Quality of Life'}]}, 'conditionsModule': {'keywords': ['Cutaneous T-cell lymphoma (CTCL)', 'Sezary Syndrome', 'Mycosis Fungoides', 'Vaccine'], 'conditions': ['Cutaneous T-cell Lymphoma', 'Sezary Syndrome']}, 'descriptionModule': {'briefSummary': 'This research is being done to look at the safety and value of a vaccine for a cancer found in the blood and skin known as Cutaneous T-cell lymphoma (CTCL) and Sezary Syndrome.\n\nIn the laboratory, researches found that special white blood cells, called dendritic cells (DCs), are able to stimulate the immune system (groups of cells that protect the body from germs and diseases) in a way that helps your body fight cancer. Autologous (from your own body) DCs will be prepared (mixed together) in the laboratory with your cancer cell (Sezary cells) to allow your DCs to pick up parts of your Sezary cells to make the vaccine for you.', 'detailedDescription': "Although the etiology of CTCL is not completely understood, immunologic factors appear to play an important role.\n\nDendritic Cell (DC)-tumor cell vaccines have several features that suggest applications for the immunotherapy of human tumors. Importantly, DC-tumor cell immunization has the potential to simultaneously stimulate CD4+ and CD8+ T cell-mediated immunity against multiple tumor antigens.\n\nThe vaccine will be prepared from the subject's own blood, obtained during leukapheresis. From leukapheresed blood, monocyte-derived DCs and malignant lymphocytes will be isolated. The DCs will then be loaded with lymphocyte-derived tumor antigens. Formulations and release criteria must be met before vaccine can be administered.\n\nCompletion date provided represents the completion date of the grant per OOPD records"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed diagnosis of Sezary syndrome\n* Must be willing to discontinue concomitant medications for CTCL, including: \\*Oral steroids above 10 mg - 30 day washout, unless subject has Addison's Disease or adrenal insufficiency, \\*PUVA or UVB - 2 week washout, sunbathing, tanning beds, etc. and for the duration of the study, \\*Electron Beam - for the duration of the study, \\*Chemotherapeutic agents - 30 day washout, \\*Bexarotene capsules or other oral biologics - 3 week washout, \\*Topical nitrogen mustard - 2 week washout, \\*Extracorporeal photopheresis - 4 week washout and for the duration of the study.\n* Must be at least 18 years of age and must be able to understand the written informed consent.\n* Subjects must have no evidence of active infection. Subjects with active infections (whether or not they require antibiotic therapy) may be eligible for continuation of therapy after complete resolution of the infection. Subjects on antibiotic therapy must be off antibiotics for at least 7 days before beginning treatment.\n\nExclusion Criteria:\n\n* Subjects with autoimmune disease, HIV, and/or hepatitis\n* Subjects who are pregnant or lactating"}, 'identificationModule': {'nctId': 'NCT00099593', 'briefTitle': 'Immunization Against Tumor Cells in Sezary Syndrome', 'organization': {'class': 'FED', 'fullName': 'FDA Office of Orphan Products Development'}, 'officialTitle': 'Phase II Evaluation of Immunization Against Tumor Cells in Subjects With Sezary Syndrome Using Autologous Mature Dendritic Cells', 'orgStudyIdInfo': {'id': 'FD-R-002545-01'}, 'secondaryIdInfos': [{'id': 'FD-R-002545-01'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Autologous Dendritic Cell Vaccine', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center, Department of Dermatology', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Larisa J. Geskin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}}}}