Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-31 @ 11:14 PM
Study NCT ID:
NCT02063893
Status:
COMPLETED
Last Update Posted:
2015-06-03
First Post:
2014-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Cancer Stem Cell Vaccinie to Treat Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'We will keep the CSC of every patient'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-01', 'studyFirstSubmitDate': '2014-02-11', 'studyFirstSubmitQcDate': '2014-02-13', 'lastUpdatePostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The dose of CSC vaccine', 'timeFrame': 'up to 3 months'}], 'primaryOutcomes': [{'measure': 'The primary study purpose to determine the safety of immunization with cancer stem cells vaccinie by the number of participants with adverse events', 'timeFrame': 'up to 3 months'}], 'secondaryOutcomes': [{'measure': 'The secondary objectives are to evaluate vaccinie immune responses to the immunizations by the data of body measurements', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Neoplasms, Breast']}, 'referencesModule': {'references': [{'pmid': '22473314', 'type': 'RESULT', 'citation': 'Ning N, Pan Q, Zheng F, Teitz-Tennenbaum S, Egenti M, Yet J, Li M, Ginestier C, Wicha MS, Moyer JS, Prince ME, Xu Y, Zhang XL, Huang S, Chang AE, Li Q. Cancer stem cell vaccination confers significant antitumor immunity. Cancer Res. 2012 Apr 1;72(7):1853-64. doi: 10.1158/0008-5472.CAN-11-1400.'}], 'seeAlsoLinks': [{'url': 'http://www.fudahospital.com/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors into immunosuppressed mice, preventing an assessment on the immunologic interactions and effects of CSCs. In this study, the investigators examined the vaccination effects produced by CSC-enriched populations from histologically distinctmurine tumors after their inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic and more effective as an antigen source than unselected tumor cells in inducing protective antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed antibodies and T cells were capable of selective targeting CSCs and conferring antitumor immunity.', 'detailedDescription': 'To assess the feasibility of generating CSC-loaded DC vaccines for clinical use, the investigators will harvest peripheral blood and tumor specimen from patients with Breast Cancer. The investigators will purify T, B cells and generate DCs from the PBMCs of the Breast Cancer patient.On the other hand, investigators will isolate ALDHhigh and ALDHlow tumor cells from the tumor specimen of the Breast Cancer patient using a similar protocol as investigators reported .\n\nAim 1: To demonstrate, in vitro, the relative cellular anti-Breast Cancer CSC immunity induced by Breast Cancer CSC-DC primed cytotoxic T cells.\n\nAim 2: To determine, in vitro, specific binding and lysis of Breast Cancer CSCs by antibodies produced by purified B cells from PBMCs stimulated with Breast Cancer CSC-DC.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients who unresectable after Cryotherapy', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient is ≥ 30 years of age at the time the informed consent to screening has been obtained;\n* The patient has one of the following histologically confirmed breast cancer subtypes:\n\nEstrogen receptor and/or progesterone positive tumor; Human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer; HER2-negative breast cancer.\n\n\\-- The patient shows normal organ function according to the following parameters(as measured within six weeks prior to treatment allocation):\n\n* Hemoglobin: Within normal range according to institutional standards;\n* Absolute leukocyte count: Within normal range according to institutional standards;\n* Absolute lymphocyte count: Within normal range according to institutional standards;\n* Platelet count: Within normal range according to institutional standards;\n* Alanine aminotransferase: ≤ 2.5 x Upper Limit of Normal (ULN);\n* Aspartate aminotransferase: ≤ 2.5 x ULN;\n* Total bilirubin: ≤ 1.5 x ULN. In the case of known Gilbert's syndrome ≤ 2 x ULN;\n* Serum creatinine: 1.5 x ULN;\n* Calculated creatinine clearance: \\> 50 mL/min .\n\nExclusion Criteria:\n\n* The patient has inflammatory breast cancer, which is defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion.\n* Diagnosis established by incisional biopsy.\n* Prior and concomitant neoadjuvant anti-breast-cancer treatments such as chemotherapy, immunotherapy / biological response modifiers, endocrine therapy, and radiotherapy, unless authorized specifically by the protocol.\n* level 3 hypertension;\n* severe coronary disease;\n* myelosuppression;\n* respiratory disease;\n* brain metastasis;\n* chronic infections"}, 'identificationModule': {'nctId': 'NCT02063893', 'acronym': 'CSC', 'briefTitle': 'Safety Study of Cancer Stem Cell Vaccinie to Treat Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fuda Cancer Hospital, Guangzhou'}, 'officialTitle': 'Study of Cancer Stem Cell Vcccinie That as a Specific Antigen in Metastatic Adenocarcinoma of the Breast', 'orgStudyIdInfo': {'id': 'CLB-001'}, 'secondaryIdInfos': [{'id': '201401', 'type': 'OTHER_GRANT', 'domain': 'The research fund of Fuda cancer hospital in Guangzhou'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'non-vaccine'}, {'label': 'giving low vaccine'}, {'label': 'giving middle vaccine'}, {'label': 'giving high vaccine'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Biological treatment center in Fuda cancer hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fuda Cancer Hospital, Guangzhou', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Michigan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}