Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-02-25 @ 7:04 PM
Study NCT ID:
NCT00619112
Status:
COMPLETED
Last Update Posted:
2018-01-31
First Post:
2008-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Temozolomide in Treating Patients With Recurrent High-Grade Glioma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D018316', 'term': 'Gliosarcoma'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D009837', 'term': 'Oligodendroglioma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Butowski@neurosurg.ucsf.edu', 'phone': '4153532966', 'title': 'Nicholas Butowski', 'organization': 'UCSF'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The trial reached enrollment. There were no unexpected toxicities.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Temozolomide', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 38, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 28}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervous system disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular access complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '6 Month Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glioblastoma', 'description': 'Glioblastoma patients were treated with temozolomide at a dose of 150mg/m\\^2 daily for seven consecutive days of every other week.\n\nOne 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14'}, {'id': 'OG001', 'title': 'Grade III Glioma', 'description': 'Grade III glioma patients were treated with temozolomide at a dose of 150mg/m\\^2 daily for seven consecutive days of every other week.\n\nOne 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '24'}, {'value': '50', 'groupId': 'OG001', 'lowerLimit': '27', 'upperLimit': '73'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First day of treatment until progression or until 6 months mark', 'description': 'Efficacy of dose-intense temozolomide treatment schedule, as measured by 6 months progression-free survival', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS) Based on Tumor MGMT (O(6)-Methylguanine-DNA Methyltransferase) Promoter Methylation Status.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Glioblastoma With Methylated MGMT', 'description': 'PFS of Glioblastoma patients with methylated MGMT tumors'}, {'id': 'OG001', 'title': 'Glioblastoma With Unmethylated MGMT', 'description': 'PFS of Glioblastoma patients with unmethylated MGMT tumors'}, {'id': 'OG002', 'title': 'Grade III Glioma With Methylated MGMT', 'description': 'PFS of Grade III Glioma patients with methylated MGMT tumors'}, {'id': 'OG003', 'title': 'Grade III Glioma With Unmethylated MGMT', 'description': 'PFS of Grade III Glioma patients with unmethylated MGMT tumors'}], 'classes': [{'categories': [{'measurements': [{'value': '8.14', 'comment': 'Upper confidence limit for median cannot be estimated (not yet reached).', 'groupId': 'OG000', 'lowerLimit': '7.71', 'upperLimit': 'NA'}, {'value': '7.57', 'groupId': 'OG001', 'lowerLimit': '7.29', 'upperLimit': '9'}, {'value': '38.1', 'comment': 'Upper confidence limit for median cannot be estimated (not yet reached).', 'groupId': 'OG002', 'lowerLimit': '10.71', 'upperLimit': 'NA'}, {'value': '48.6', 'comment': 'Upper confidence limit for median cannot be estimated (not yet reached).', 'groupId': 'OG003', 'lowerLimit': '6.86', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'First day of treatment until progression or until 6 months mark', 'description': 'Progression-free survival data (obtained for Primary Outcome Measure) was correlated with tumor MGMT (O(6)-methylguanine-DNA methyltransferase) promoter methylation status, obtained from patients as part of the study.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Tumor tissue was available for the exploratory MGMT methylation analysis in 48 patients. In 7 samples the tissue was inadequate for analysis.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glioblastoma', 'description': 'Glioblastoma patients were treated with temozolomide at a dose of 150mg/m\\^2 daily for seven consecutive days of every other week.\n\nOne 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14'}, {'id': 'OG001', 'title': 'Grade III Glioma', 'description': 'Grade III glioma patients were treated with temozolomide at a dose of 150mg/m\\^2 daily for seven consecutive days of every other week.\n\nOne 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14'}], 'classes': [{'categories': [{'measurements': [{'value': '21.6', 'groupId': 'OG000', 'lowerLimit': '16.9', 'upperLimit': '30.6'}, {'value': '100.6', 'comment': 'The upper bound was not reached during length of the study.', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 2 years after treatment', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patients With Tumors With Functional Alterations of the Mismatch Repair (MMR) System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glioblastoma', 'description': 'Glioblastoma patients were treated with temozolomide at a dose of 150mg/m\\^2 daily for seven consecutive days of every other week.\n\nOne 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14'}, {'id': 'OG001', 'title': 'Grade III Glioma', 'description': 'Grade III glioma patients were treated with temozolomide at a dose of 150mg/m\\^2 daily for seven consecutive days of every other week.\n\nOne 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'prior to start of study', 'description': 'PCR analysis of tumor tissue for microsatellite instability (MSI). Tissue was obtained during surgeries prior this study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patients Progressing After Two First-line Adjuvant Courses of Temozolomide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glioblastoma', 'description': 'Glioblastoma patients were treated with temozolomide at a dose of 150mg/m\\^2 daily for seven consecutive days of every other week.\n\nOne 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14'}, {'id': 'OG001', 'title': 'Grade III Glioma', 'description': 'Grade III glioma patients were treated with temozolomide at a dose of 150mg/m\\^2 daily for seven consecutive days of every other week.\n\nOne 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After two first-line adjuvant courses of temozolomide', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patients Progressing Within 6 Months After 6th Adjuvant Course of Temozolomide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glioblastoma', 'description': 'Glioblastoma patients were treated with temozolomide at a dose of 150mg/m\\^2 daily for seven consecutive days of every other week.\n\nOne 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14'}, {'id': 'OG001', 'title': 'Grade III Glioma', 'description': 'Grade III glioma patients were treated with temozolomide at a dose of 150mg/m\\^2 daily for seven consecutive days of every other week.\n\nOne 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 6 months after 6th adjuvant course of temozolomide', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patients Progressing 6 Months After Temozolomide is Voluntarily Discontinued', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glioblastoma', 'description': 'Glioblastoma patients were treated with temozolomide at a dose of 150mg/m\\^2 daily for seven consecutive days of every other week.\n\nOne 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14'}, {'id': 'OG001', 'title': 'Grade III Glioma', 'description': 'Grade III glioma patients were treated with temozolomide at a dose of 150mg/m\\^2 daily for seven consecutive days of every other week.\n\nOne 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From beginning of voluntarily temozolomide discontinued up to 6 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Glioblastoma', 'description': 'Glioblastoma patients were treated with temozolomide at a dose of 150mg/m\\^2 daily for seven consecutive days of every other week.\n\nOne 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14'}, {'id': 'FG001', 'title': 'Grade III Glioma', 'description': 'Grade III glioma patients were treated with temozolomide at a dose of 150mg/m\\^2 daily for seven consecutive days of every other week.\n\nOne 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': "Data from patient who didn't complete study was still included in the final analysis.", 'groupId': 'FG000', 'numSubjects': '39'}, {'comment': "Data from patients who didn't complete study was still included in the final analysis.", 'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Patients recruited from within established neuro oncology clinic at UCSF. First paient 11.5.2007 and last patient 1.24.2012'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Glioblastoma', 'description': 'Glioblastoma patients were treated with temozolomide at a dose of 150mg/m\\^2 daily for seven consecutive days of every other week.\n\nOne 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14'}, {'id': 'BG001', 'title': 'Grade III Glioma', 'description': 'Grade III glioma patients were treated with temozolomide at a dose of 150mg/m\\^2 daily for seven consecutive days of every other week.\n\nOne 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000', 'lowerLimit': '30', 'upperLimit': '68'}, {'value': '48', 'groupId': 'BG001', 'lowerLimit': '27', 'upperLimit': '70'}, {'value': '53', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '70'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-05', 'studyFirstSubmitDate': '2008-02-19', 'resultsFirstSubmitDate': '2013-06-17', 'studyFirstSubmitQcDate': '2008-02-19', 'lastUpdatePostDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-08-22', 'studyFirstPostDateStruct': {'date': '2008-02-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 Month Progression-free Survival', 'timeFrame': 'First day of treatment until progression or until 6 months mark', 'description': 'Efficacy of dose-intense temozolomide treatment schedule, as measured by 6 months progression-free survival'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival (PFS) Based on Tumor MGMT (O(6)-Methylguanine-DNA Methyltransferase) Promoter Methylation Status.', 'timeFrame': 'First day of treatment until progression or until 6 months mark', 'description': 'Progression-free survival data (obtained for Primary Outcome Measure) was correlated with tumor MGMT (O(6)-methylguanine-DNA methyltransferase) promoter methylation status, obtained from patients as part of the study.'}, {'measure': 'Overall Survival', 'timeFrame': 'up to 2 years after treatment'}, {'measure': 'Patients With Tumors With Functional Alterations of the Mismatch Repair (MMR) System', 'timeFrame': 'prior to start of study', 'description': 'PCR analysis of tumor tissue for microsatellite instability (MSI). Tissue was obtained during surgeries prior this study.'}, {'measure': 'Patients Progressing After Two First-line Adjuvant Courses of Temozolomide', 'timeFrame': 'After two first-line adjuvant courses of temozolomide'}, {'measure': 'Patients Progressing Within 6 Months After 6th Adjuvant Course of Temozolomide', 'timeFrame': 'Within 6 months after 6th adjuvant course of temozolomide'}, {'measure': 'Patients Progressing 6 Months After Temozolomide is Voluntarily Discontinued', 'timeFrame': 'From beginning of voluntarily temozolomide discontinued up to 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adult glioblastoma', 'adult gliosarcoma', 'adult anaplastic astrocytoma', 'adult anaplastic oligodendroglioma', 'adult mixed glioma', 'recurrent adult brain tumor'], 'conditions': ['Recurrent Central Nervous System Neoplasm']}, 'referencesModule': {'references': [{'pmid': '24670608', 'type': 'DERIVED', 'citation': 'Han SJ, Rolston JD, Molinaro AM, Clarke JL, Prados MD, Chang SM, Berger MS, DeSilva A, Butowski NA. Phase II trial of 7 days on/7 days off temozolmide for recurrent high-grade glioma. Neuro Oncol. 2014 Sep;16(9):1255-62. doi: 10.1093/neuonc/nou044. Epub 2014 Mar 26.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.\n\nPURPOSE: This phase II trial is studying how well temozolomide works in treating patients with recurrent high-grade glioma.', 'detailedDescription': "OBJECTIVES:\n\nPrimary\n\n* Determine the efficacy, as measured by 6-month progression-free survival, of a dose-intense temozolomide treatment schedule in patients with recurrent high-grade glioma.\n\nSecondary\n\n* Assess the toxicities of this dose-intense temozolomide.\n* Determine the overall survival of patients treated with this dose-intense schedule.\n* Determine whether methylation status of the MGMT gene within patients' tumors predicts greater efficacy (progression-free survival), in patients treated on this protocol.\n* Determine whether patients' tumors have functional alterations of the mismatch repair (MMR) system by PCR analysis for microsatellite instability (MSI) and whether such alterations may influence outcome in patients treated on this protocol.\n* Determine how initial success with temozolomide may influence outcome in recurrent patients treated on this protocol by evaluating patients progressing after two first-line adjuvant courses of temozolomide, patients progressing within 6 months after the 6th adjuvant course of temozolomide, and patients progressing 6 months after temozolomide is voluntarily discontinued.\n\nOUTLINE: Patients receive oral temozolomide once daily on days 1-7 and days 15-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\n\nFormalin-fixed paraffin-embedded tissue blocks or unstained paraffin slides from available surgical samples are evaluated for molecular abnormalities in the tumor, including (but not limited to) MGMT status and microsatellite instability.\n\nAfter completion of study therapy, patients are followed every 3 months for survival.\n\nPROJECTED ACCRUAL: A total of 40 patients with WHO II grade 4 tumors (glioblastoma multiforme \\[GBM\\]) and 20 patients with WHO II grade 3 tumors (non-GBM) will be accrued for this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Patients with radiographically proven recurrent, intracranial malignant glioma will be eligible for this protocol.\n* All patients must sign an informed consent\n* Patients must have had external beam radiation; there is no limit to the number of prior chemotherapies used.\n* Patients must be \\> 18 years old, and with a life expectancy \\> 8 weeks.\n* Patients must have a Karnofsky performance status of \\> 60.\n* At the time of registration: Patients must have recovered from the toxic effects of prior therapy:\n* Patients must have adequate bone marrow function.\n* Patients must have shown unequivocal radiographic evidence for tumor progression by MRI\n* Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply: They have recovered from the effects of surgery. Residual disease following resection of recurrent intracranial malignant glioma is not mandated for eligibility into the study.\n* Patients must have failed prior radiation therapy and must have an interval of greater than or equal to 42 days from the completion of radiation therapy to study entry.\n* Patients with prior therapy that included interstitial brachytherapy, stereotactic radiosurgery, or Gliadel wafers must have confirmation of true progressive disease rather than radiation necrosis based upon either PET or MR spectroscopy or surgical documentation of disease.\n* Male and female patients with reproductive potential must use an approved contraceptive method\n\nExclusion Criteria\n\n* Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy\n* Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible.\n* Patients must not have active infection or serious intercurrent medical illness.\n* Patients must not be pregnant/breast feeding and must agree to practice adequate contraception."}, 'identificationModule': {'nctId': 'NCT00619112', 'briefTitle': 'Temozolomide in Treating Patients With Recurrent High-Grade Glioma', 'nctIdAliases': ['NCT00539552'], 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Phase II Study of 7 Days On/7 Days Off Temozolomide in Patients With High-Grade Glioma', 'orgStudyIdInfo': {'id': 'UCSF-07107'}, 'secondaryIdInfos': [{'id': 'SPRI-UCSF-H44867-31182-01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Temozolomide', 'description': 'single arm trial; Patients treated with temozolomide at a dose of 150mg/m2 daily for seven consecutive days of every other week. One 28-day cycle will include treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14', 'interventionNames': ['Drug: temozolomide']}], 'interventions': [{'name': 'temozolomide', 'type': 'DRUG', 'otherNames': ['temodar'], 'description': 'single arm study', 'armGroupLabels': ['Temozolomide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Helen Diller Family Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Nicholas A. Butowski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Susan M. Chang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}