Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-03-16 @ 7:24 PM
Study NCT ID:
NCT02115958
Status:
COMPLETED
Last Update Posted:
2019-09-12
First Post:
2014-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Immunotherapy of Nasopharyngeal Cancer Using Cancer Stem Cells Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2014-04-14', 'studyFirstSubmitQcDate': '2014-04-14', 'lastUpdatePostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', '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 vaccine by the number of participants with adverse events', 'timeFrame': 'up to 3 months'}], 'secondaryOutcomes': [{'measure': 'The secondary objectives are to evaluate vaccine immune responses to the immunizations by the data of body measurements', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Neoplasms, Lung']}, '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 distinct murine 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 Nasopharyngeal Cancer. The investigators will purify T, B cells and generate DCs from the PBMCs of the nasopharyngeal cancer patient.On the other hand, investigators will isolate ALDHhigh and ALDHlow tumor cells from the tumor specimen of the nasopharyngeal cancer patient using a similar protocol as investigators reported .\n\nAim 1: To demonstrate, in vitro, the relative cellular anti-nasopharyngeal cancer CSC immunity induced by nasopharyngeal cancer CSC-DC primed cytotoxic T cells.\n\nAim 2: To determine, in vitro, specific binding and lysis of nasopharyngeal cancer CSCs by antibodies produced by purified B cells from PBMCs stimulated with nasopharyngeal cancer CSC-DC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1.patients are greater than 18 years of age, with advanced local disease (T3-T4N0-1M0), nodal disease (T1-T2N2-3M0) and loco-regional disease (T3-T4N2-3M0) at onset but presently controlled by standard therapy (combination of chemotherapy and radiotherapy) or with completely resected metastatic disease.\n\n 2.Pathologic confirmation of nasopharyngeal carcinoma by the NCI Laboratory of Pathology (NPC).\n\n 3.serum creatinine of 2.0 mg/dl or less. 4.Total bilirubin 1.6 mg/dl or less, except for patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.\n\n 5.WBC 3000/mm(3) or greater. 6.platelet count 90,000 mm(3) or greater. 7.serum AST/ALT less than three times normal. 8.ECOG performance status of 0 or 1. 9.Patients of both genders must be willing to practice effective birth control during this trial because the potential for teratogenic effects are unknown.\n\n 10.Patients may have had prior adjuvant treatment or may have had treatment for metastatic disease and are now with no evidence of disease, including chemotherapy or biotherapy, as long as 1 month has elapsed since prior systemic therapy.\n\nExclusion Criteria:\n\n1\\. Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV. 2. level 3 hypertension; 3. severe coronary disease; 4. myelosuppression; 5. respiratory disease; 6. brain metastasis; 7. chronic infections"}, 'identificationModule': {'nctId': 'NCT02115958', 'briefTitle': 'The Immunotherapy of Nasopharyngeal Cancer Using Cancer Stem Cells Vaccine', 'organization': {'class': 'OTHER', 'fullName': 'Fuda Cancer Hospital, Guangzhou'}, 'officialTitle': 'Study of Cancer Stem Cell Vaccine That as a Specific Antigen in Metastatic of the Nasopharynx', 'orgStudyIdInfo': {'id': 'CLN-001'}, 'secondaryIdInfos': [{'id': '201401', 'type': 'OTHER_GRANT', 'domain': 'The research fund of Fuda cancer hospital in Guangzhou'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'non-cancer stem cell vaccine', 'description': 'The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.', 'interventionNames': ['Biological: cancer stem cell vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'giving low dose vaccine', 'description': 'The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.', 'interventionNames': ['Biological: cancer stem cell vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'giving middle dose vaccine', 'description': 'The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.', 'interventionNames': ['Biological: cancer stem cell vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'giving high dose vaccine', 'description': 'The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.', 'interventionNames': ['Biological: cancer stem cell vaccine']}], 'interventions': [{'name': 'cancer stem cell vaccine', 'type': 'BIOLOGICAL', 'armGroupLabels': ['giving high dose vaccine', 'giving low dose vaccine', 'giving middle dose vaccine', 'non-cancer stem cell 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'}}}}