Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-01-01 @ 5:23 AM
Study NCT ID:
NCT02494804
Status:
NOT_YET_RECRUITING
Last Update Posted:
2015-07-10
First Post:
2015-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Cytokine-induced Killer Cells for Stage I-II Malignant Gliomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2030-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-08', 'studyFirstSubmitDate': '2015-07-08', 'studyFirstSubmitQcDate': '2015-07-08', 'lastUpdatePostDateStruct': {'date': '2015-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cytokine-Induced Killer Cells', 'Milignant Gliomas', 'Temozolomide'], 'conditions': ['Cytokine-Induced Killer Cells', 'Milignant Gliomas']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether combining of Temozolomide and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with Malignant Gliomas. The effectiveness and safety of CIK cells for the treatment of Malignant Glioma is also evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHistologically confirmed intracranial Grade 1 or 2 anaplastic glioma or glioblastoma (astrocytic tumor, anaplastic oligodendroglioma, or oligoastrocytoma).\n\nReceived prior standard radiation for a Grade 3 or 4 astrocytic tumor with a minimum cumulative dose of 40 Gy administered.\n\nCompleted at least one full cycle of temozolomide of 200 mg/m2/day administered on Days 1-5 of a 28-day cycle, without unacceptable toxicity or progression.\n\nKarnofsky performance status of 60 or more. Adequate organ and bone marrow function as defined by hematological and serum chemistry limits.\n\nAt least 18 years old. Both men and women must practice adequate contraception. Informed consent.\n\nExclusion Criteria:\n\nProgressed while on temozolomide. Evidence of acute intracranial or intratumoral hemorrhage \\> Grade 1. Not recovered from the toxic effects of prior therapy. Pregnant or breast feeding. History of diabetes mellitus. Uncontrolled intercurrent illness. Congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study.\n\nHIV positive. Diagnosis of another malignancy may exclude subject from study.'}, 'identificationModule': {'nctId': 'NCT02494804', 'briefTitle': 'Effect of Cytokine-induced Killer Cells for Stage I-II Malignant Gliomas', 'organization': {'class': 'OTHER', 'fullName': "The First People's Hospital of Changzhou"}, 'officialTitle': 'A Study of CIK in Combination With Temozolomide With and Without Radiation in Adults With Stage I-II Malignant Gliomas', 'orgStudyIdInfo': {'id': 'GLICIK001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Temozolomide', 'description': 'Capsules supplied in 5-mg, 20-mg, 100-mg, 140-mg, 180-mg, and 250-mg strengths; dosed at 200 mg/m2/day for 5 consecutive days, repeated every 28 days', 'interventionNames': ['Drug: Temozolomide']}, {'type': 'OTHER', 'label': 'Temozolomide+CIK', 'description': 'Autologous cytokine-induced killer cells were transfer via venous one week after Temozolomide treat', 'interventionNames': ['Biological: CIK']}], 'interventions': [{'name': 'Temozolomide', 'type': 'DRUG', 'description': 'Capsules supplied in 5-mg, 20-mg, 100-mg, 140-mg, 180-mg, and 250-mg strengths; dosed at 200 mg/m2/day for 5 consecutive days, repeated every 28 days', 'armGroupLabels': ['Temozolomide']}, {'name': 'CIK', 'type': 'BIOLOGICAL', 'description': 'The patients received autologous cytokine-induced killer cells transfusion one week after Temozolomide treat', 'armGroupLabels': ['Temozolomide+CIK']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Changping Wu, M.D', 'role': 'CONTACT', 'email': 'wcpjjt@163.com', 'phone': '8651968870978'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "The First People's Hospital of Changzhou", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}