Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-29 @ 6:31 PM
Study NCT ID:
NCT05261750
Status:
UNKNOWN
Last Update Posted:
2022-09-26
First Post:
2022-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Dendritic Cells and Allogenic Dendritic Secretomes for Patients With Advanced Nasopharyngeal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}], 'ancestors': [{'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-23', 'studyFirstSubmitDate': '2022-02-20', 'studyFirstSubmitQcDate': '2022-02-20', 'lastUpdatePostDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Karnofsky Performance Status', 'timeFrame': 'Before therapy', 'description': "To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100."}, {'measure': 'Karnofsky Performance Status', 'timeFrame': '1 week after therapy', 'description': "To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100."}, {'measure': 'Karnofsky Performance Status', 'timeFrame': '1 month after therapy', 'description': "To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100."}, {'measure': 'Karnofsky Performance Status', 'timeFrame': '3 months after therapy', 'description': "To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dendritic Cells', 'Dendritic Secretomes'], 'conditions': ['Nasopharyngeal Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and potential of dendritic cells therapy and secretomes therapy for advanced nasopharyngeal cancer.', 'detailedDescription': 'There are controlled group who receives standard medical theraphy (radiotherapy or chemoradiation), one group who receives standard medical theraphy (radiotherapy or chemoradiation) and Auto-dendritic adjuvant therapy, and other group who receives standard medical theraphy (radiotherapy or chemoradiation) and Allo-dendritic-secretomes adjuvant therapy and continued with auto-dendritic therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who tested positive EBV and confirmed suffering advanced nasopharyngeal cancer\n* Patients who have partial response or stable disease or progressive disease after performed standard therapy (radiology or chemoradiation) based on RECIST\n* Did not take traditional medicine in the last 2 months.\n* Patients can understand the nature of the study and willing to sign informed consent\n* Patients who received standard medical (radiology or chemoradiation) up to one additional therapy in the last 1 month.\n\nExclusion Criteria:\n\n* Patients who are pregnant, planning to pregnant, or breastfeeding\n* Patients assessed to require chemoradiation during this study\n* Patients who get complete score after undergo standard therapy (radiology or chemoradiation) based on the RECIST\n* Patients who have autoimun reaction, eczema, allergy or allergy history, and anaphylaxis\n* Patients who have creatinin clearance result \\<40 ml/min, bilirubin serum \\>1.5x above normal, SGPT-SGOT \\>5x above normal\n* Patients on immunosuppressive medications, such as corticosteroids\n* Patients who undergo Major thoracic or abdominal operation\n* Patients on high medical risk condition due to uncontrolled infection\n* Patients who diagnosed positive of Hepatitis B, Hepatitis C or Human Immunodeificiency virus (HIV)\n* Patients who have concurrent congestive heart failure history and other heart disease\n* Patients who have health conditions assessed by the doctor in charge cannot be included in this clinical trial\n* Patients who refuse or did not participate in part or all of the research process'}, 'identificationModule': {'nctId': 'NCT05261750', 'briefTitle': 'Autologous Dendritic Cells and Allogenic Dendritic Secretomes for Patients With Advanced Nasopharyngeal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'PT. Prodia Stem Cell Indonesia'}, 'officialTitle': 'Safety and Efficacy of Adjuvant Therapy of Autologous Dendritic Cells and Allogenic Dendritic Secretomes for Patients With Advanced Nasopharyngeal Cancer', 'orgStudyIdInfo': {'id': 'CT/NPC/PSI/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Auto-Dendritic Adjuvant Therapy', 'description': 'Patients will be given standard medical therapy (radiotherapy or chemoradiation) and auto-dendritic adjuvant therapy via intramuscular 3 times injection every 1 week.', 'interventionNames': ['Biological: Auto-Dendritic Adjuvant Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Allo-Dendritic-secretome and Auto-Dendritic Adjuvant Therapy', 'description': 'Patients will be given standrad medical therapy (radiotherapy or chemoradiation) and allo-dendritic-secretome adjuvant therapy 2 cc 1 times injection, and then followed by auto-dendritic therapy via intramuscular 3 times injection every 1 week.', 'interventionNames': ['Biological: Allo-Dendritic-Secretome Adjuvant Therapy']}], 'interventions': [{'name': 'Auto-Dendritic Adjuvant Therapy', 'type': 'BIOLOGICAL', 'description': 'Treatment with standard medical therapy (radiotherapy or chemoradiation) and auto-dendritic adjuvant therapy via intramuscular 3 times injection every 1 week.', 'armGroupLabels': ['Auto-Dendritic Adjuvant Therapy']}, {'name': 'Allo-Dendritic-Secretome Adjuvant Therapy', 'type': 'BIOLOGICAL', 'description': 'Treatment with standard medical therapy (radiotherapy or chemoradiation) and allo-dendritic-secretome adjuvant therapy 2 cc 1 times injection, and then followed by auto-dendritic therapy via intramuscular 3 times injection every 1 week.', 'armGroupLabels': ['Allo-Dendritic-secretome and Auto-Dendritic Adjuvant Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'facility': 'PT Prodia StemCell Indonesia', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'centralContacts': [{'name': 'Budi Sulistya, dr', 'role': 'CONTACT', 'email': 's3.abudisulistya@gmail.com', 'phone': '08121103190'}, {'name': 'Cynthia Retna Sartika, Dr', 'role': 'CONTACT', 'email': 'c.sartika@gmail.com'}], 'overallOfficials': [{'name': 'Rima Haifa, B.Sc', 'role': 'STUDY_CHAIR', 'affiliation': 'Prodia Stem Cell Indonesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PT. Prodia Stem Cell Indonesia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}