Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-27 @ 10:03 PM
Study NCT ID:
NCT00070161
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2003-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D003397', 'term': 'Craniopharyngioma'}, {'id': 'D008527', 'term': 'Medulloblastoma'}, {'id': 'D008579', 'term': 'Meningioma'}, {'id': 'D016545', 'term': 'Choroid Plexus Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D009837', 'term': 'Oligodendroglioma'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D018315', 'term': 'Glioma, Subependymal'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D004806', 'term': 'Ependymoma'}, {'id': 'D010871', 'term': 'Pinealoma'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D018316', 'term': 'Gliosarcoma'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D002551', 'term': 'Cerebral Ventricle Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C063170', 'term': 'Ginkgo biloba extract'}, {'id': 'D000077265', 'term': 'Donepezil'}, {'id': 'D000073216', 'term': 'Mental Status and Dementia Tests'}], 'ancestors': [{'id': 'D007189', 'term': 'Indans'}, {'id': 'D007192', 'term': 'Indenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D009483', 'term': 'Neuropsychological Tests'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2012-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-07', 'studyFirstSubmitDate': '2003-10-03', 'studyFirstSubmitQcDate': '2003-10-06', 'lastUpdatePostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-05-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['radiation toxicity', 'adult mixed glioma', 'adult central nervous system germ cell tumor', 'adult brain stem glioma', 'adult craniopharyngioma', 'adult medulloblastoma', 'adult meningioma', 'adult choroid plexus tumor', 'adult tumors metastatic to brain', 'adult anaplastic oligodendroglioma', 'adult anaplastic astrocytoma', 'adult pilocytic astrocytoma', 'adult subependymoma', 'adult meningeal hemangiopericytoma', 'adult ependymoblastoma', 'adult anaplastic ependymoma', 'adult pineoblastoma', 'adult pineocytoma', 'adult myxopapillary ependymoma', 'adult glioblastoma', 'adult grade III meningioma', 'adult oligodendroglioma', 'adult giant cell glioblastoma', 'adult gliosarcoma', 'adult ependymoma'], 'conditions': ['Brain and Central Nervous System Tumors', 'Radiation Toxicity']}, 'referencesModule': {'references': [{'pmid': '16549835', 'type': 'RESULT', 'citation': "Shaw EG, Rosdhal R, D'Agostino RB Jr, Lovato J, Naughton MJ, Robbins ME, Rapp SR. Phase II study of donepezil in irradiated brain tumor patients: effect on cognitive function, mood, and quality of life. J Clin Oncol. 2006 Mar 20;24(9):1415-20. doi: 10.1200/JCO.2005.03.3001."}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Donepezil and EGb761 may be effective in improving neurocognitive function (such as thinking, attention, concentration, and memory) and may improve quality of life in patients who have undergone radiation therapy to the brain.\n\nPURPOSE: This phase II trial is studying how well donepezil or EGb761 works in improving neurocognitive function in patients who have undergone radiation therapy for primary brain tumor or brain metastases.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the effect of donepezil or EGb761 on neurocognitive function in patients who underwent radiotherapy for a primary brain tumor or brain metastases at least 6 months before study registration.\n\nSecondary\n\n* Determine the toxicity of these drugs in these patients.\n* Determine the quality of life of patients treated with these drugs.\n* Quantify the extent of radiation-induced white matter disease and temporal lobe atrophy in patients treated with these drugs.\n\nOUTLINE: This is an open-label, multicenter study.\n\n* Group 1 (closed to accrual 10/09/03): Patients receive oral donepezil once daily for 24 weeks.\n* Group 2: Patients receive oral EGb761 three times daily for 24 weeks. In both groups (group 1 closed to accrual 10/09/03), treatment continues in the absence of unacceptable toxicity.\n\nIn both groups (group 1 closed to accrual 10/09/03), quality of life and neurocognitive assessment is performed at baseline and at weeks 6 (group 1 only), 12, 24, and 30.\n\nPatients are followed at 6 weeks.\n\nPROJECTED ACCRUAL: A total of 70 patients (35 per treatment group) will be accrued for this study within 9.5 months. (Group 1 closed to accrual 10/09/03)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of primary brain tumor or brain metastases, meeting 1 of the following criteria:\n\n * No radiographic evidence of disease\n * Stable disease, defined as no tumor progression within the past 3 months\n* Previously treated with 1 course of localized or whole brain radiotherapy of at least 3,000 cGy at least 6 months before study registration\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Karnofsky 70-100%\n\nLife expectancy\n\n* At least 30 weeks\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* No concurrent chemotherapy\n\nEndocrine therapy\n\n* Concurrent steroid therapy allowed if on stable or decreasing dose\n\nRadiotherapy\n\n* See Disease Characteristics\n* No concurrent cranial radiotherapy\n\nSurgery\n\n* No concurrent surgery\n\nOther\n\n* More than 3 months since prior donepezil or EGb761\n* No concurrent donepezil (group 2 only)\n* No concurrent EGb761 (group 1 only) (closed to accrual 10/09/03)\n* No concurrent anticoagulants (e.g., aspirin, dipyridamole, heparin, warfarin, or enoxaparin) (group 2 only)\n* No concurrent monoamine oxidase inhibitors (e.g., phenelzine or tranylcypromine)\n* No other concurrent therapy'}, 'identificationModule': {'nctId': 'NCT00070161', 'briefTitle': 'Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases', 'orgStudyIdInfo': {'id': 'REBACCCWFU-97100'}, 'secondaryIdInfos': [{'id': 'U10CA081851', 'link': 'https://reporter.nih.gov/quickSearch/U10CA081851', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'EGb761', 'type': 'DIETARY_SUPPLEMENT'}, {'name': 'donepezil hydrochloride', 'type': 'DRUG'}, {'name': 'cognitive assessment', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006-2726', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'CCOP - Western Regional, Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '30165', 'city': 'Rome', 'state': 'Georgia', 'country': 'United States', 'facility': 'Regional Radiation Oncology Center at Rome', 'geoPoint': {'lat': 34.25704, 'lon': -85.16467}}, {'zip': '27157-1030', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Comprehensive Cancer Center at Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'CCOP - Upstate Carolina', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}], 'overallOfficials': [{'name': 'Edward G. Shaw, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}