Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-27 @ 11:50 PM
Study NCT ID:
NCT00045734
Status:
COMPLETED
Last Update Posted:
2017-05-15
First Post:
2002-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Imatinib Mesylate in Treating Patients With Recurrent Meningioma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008579', 'term': 'Meningioma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068877', 'term': 'Imatinib Mesylate'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jfisher@jhmi.edu', 'phone': '410-955-8837', 'title': 'Patrick Wen, MD', 'organization': 'Adult Brain Tumor Consortium (ABTC)'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': "The study was closed prematurely due to limited activity and slow accrual. Study was designed to enroll (statistically powered) for 30 patients into each group (30 benign; 30 Atypical and 30 Anaplastic) meningioma's. Study enroll only 23 patients."}}, 'adverseEventsModule': {'timeFrame': '3 years', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment (Imatinib Mesylate)', 'description': 'Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nOther: pharmacological study/ laboratory biomarker analysis\n\nimatinib mesylate: Given orally\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies', 'otherNumAtRisk': 22, 'otherNumAffected': 10, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'CNS (intracranial) Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'dehydrations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'elevated serum glutamic pyruvic transaminase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '6 Months - Progression-free Survival According to Response Evaluation Using Macdonald Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Imatinib Mesylate)', 'description': 'Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nOther: pharmacological study/ laboratory biomarker analysis\n\nimatinib mesylate: Given orally\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 6 months', 'description': 'The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (magnetic resonance imaging \\[MRI\\]) and clinical features\n\n1: complete response; 2: partial response; 3:stable disease; 4:progression\n\nComplete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved\n\nPartial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved\n\nStable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable\n\nProgression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 19 of the 23 patients were evaluable for response'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival According to Response Evaluation Using Macdonald Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Imatinib Mesylate)', 'description': 'Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nOther: pharmacological study/ laboratory biomarker analysis\n\nimatinib mesylate: Given orally\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '34'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 years', 'description': 'The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features\n\n1: complete response; 2: partial response; 3:stable disease; 4:progression\n\nComplete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved\n\nPartial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved\n\nStable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable\n\nProgression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 22 eligible patients only 19 were evaluable for response'}, {'type': 'SECONDARY', 'title': 'Toxicity as Assessed by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 2.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Imatinib Mesylate)', 'description': 'Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nOther: pharmacological study/ laboratory biomarker analysis\n\nimatinib mesylate: Given orally\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years after completion of study treatment', 'description': 'percentage of patients who had grade 3 or grade 4 adverse events', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tumor Response as Assessed by MRI Using Macdonald Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Imatinib Mesylate)', 'description': 'Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nOther: pharmacological study/ laboratory biomarker analysis\n\nimatinib mesylate: Given orally\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies'}], 'classes': [{'title': 'Progression', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Stable', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years', 'description': 'The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features\n\n1: complete response; 2: partial response; 3:stable disease; 4:progression\n\nComplete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved\n\nPartial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved\n\nStable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable\n\nProgression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'response at first scan'}, {'type': 'SECONDARY', 'title': 'Concentration (Steady State) of Imatinib During Cycle One (Pharmacokinetics)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Imatinib Mesylate)', 'description': 'Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nOther: pharmacological study/ laboratory biomarker analysis\n\nimatinib mesylate: Given orally\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies'}], 'classes': [{'title': 'Day 8 Pre Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2129', 'spread': '1600', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 24 hour dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2248', 'spread': '1408', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre dosing on day 8 and 24 hour dosing day 8 of Pre-dosing Day 9', 'description': 'Blood collected before and at 1,2,4 ad 24 hours after ingestion of imatinib on day 8 of cycle 1\n\nresult is the measurement of the before dosing on day 8 (trough level) and the 24 hour dosing day 8', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 14 samples available / evaluable for analysis'}, {'type': 'SECONDARY', 'title': 'Determine Survival for Patients Treated With Imatinib Mesylate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Imatinib Mesylate)', 'description': 'Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nOther: pharmacological study/ laboratory biomarker analysis\n\nimatinib mesylate: Given orally\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '48.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 years', 'description': 'survival determined from start of treatment to date of death', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'death date of 7 patients were unknown at time of analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Determine Surrogate Markers of Angiogenic Peptides Using Functional Neuro-imaging and in Vitro Bioassays', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Imatinib Mesylate)', 'description': 'Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nOther: pharmacological study/ laboratory biomarker analysis\n\nimatinib mesylate: Given orally\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies'}], 'timeFrame': '5 years', 'description': 'Study terminated early, only 22 patients entered on study. Hence, this secondary outcome was never analyzed due number of patients.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated early, only 22 patients entered on study. Hence, this secondary outcome was never analyzed due to number of patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Evidence of Platelet-derived Growth Factor (PDGF) Inhibition in Tumor Specimens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Imatinib Mesylate)', 'description': 'Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nOther: pharmacological study/ laboratory biomarker analysis\n\nimatinib mesylate: Given orally\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies'}], 'timeFrame': '- 3 years', 'description': 'insufficient samples to allow Platelet-derived growth factor receptor (PDGFR-alpha and -beta expression to be correlated Of 22 patients only 7 samples available and only 5 yielded adequate tissue', 'reportingStatus': 'POSTED', 'populationDescription': 'insufficient samples to allow PDGFR-alpha and -beta expression to be correlated Of 22 patients only 7 samples available and only 5 yielded adequate tissue'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Determine Correlating Molecular Abnormalities in the Tumor With Response to Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Imatinib Mesylate)', 'description': 'Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nOther: pharmacological study/ laboratory biomarker analysis\n\nimatinib mesylate: Given orally\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies'}], 'timeFrame': '3 years', 'description': 'Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined.\n\nComplete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids.\n\nPartial Response (PR): \\>/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone.\n\nStable/No Response: Does not qualify for CR, PR, or progression. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over Baseline (BL) if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated early, only 22 patients entered on study. Hence, this secondary outcome was never analyzed due to number of patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment (Imatinib Mesylate)', 'description': 'Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nOther: pharmacological study/ laboratory biomarker analysis\n\nimatinib mesylate: Given orally\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'patients enrolled between June 2003 ad August 2005 in an outpatient clinic setting.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment (Imatinib Mesylate)', 'description': 'Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nOther: pharmacological study/ laboratory biomarker analysis\n\nimatinib mesylate: Given orally\n\nlaboratory biomarker analysis: Correlative studies\n\npharmacological study: Correlative studies'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Karnofsky Performance Status Scale (KPS)', 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000', 'lowerLimit': '60', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'description': 'High best 100 normal no complaints no disease 90 capable of normal activity few symptoms/disease 80 normal activity w/ some difficulty some symptoms/signs 70 caring for self not capable of normal activity/work 60 requiring some help can take care of most personal requirements 50 requires help often requires frequent medical care 40 disabled requires special care/help 30 severely disabled hospital admission indicated but no risk of death 20 very ill urgently requiring admission requires supportive measures/treatment 10 moribund rapidly progressive fatal disease processes 0 death', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Histology', 'classes': [{'title': 'Benign (WHO grade I)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Atypical (WHO grade II)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Anaplastic (WHO grade III)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'using the WHO classification histology code which is the International classification for Oncology\n\nBenign (WHO grade I) Atypical (WHO grade II) Anaplastic (WHO grade III)', 'unitOfMeasure': 'participants'}, {'title': 'Prior Surgeries', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'surgeries', 'dispersionType': 'FULL_RANGE'}, {'title': 'Prior Radiation Therapies', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Radiation Therapies', 'dispersionType': 'FULL_RANGE'}, {'title': 'Prior Chemotherapy Regimens', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Chemotherapy Regimens', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': '23 patients were enrolled and evaluated however 1 patient was found to be ineligible as patient had a second malignancy within 3 years of registration. Demographics for this patient are reported.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-02', 'studyFirstSubmitDate': '2002-09-06', 'resultsFirstSubmitDate': '2017-03-10', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-02', 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Determine Surrogate Markers of Angiogenic Peptides Using Functional Neuro-imaging and in Vitro Bioassays', 'timeFrame': '5 years', 'description': 'Study terminated early, only 22 patients entered on study. Hence, this secondary outcome was never analyzed due number of patients.'}, {'measure': 'Evidence of Platelet-derived Growth Factor (PDGF) Inhibition in Tumor Specimens', 'timeFrame': '- 3 years', 'description': 'insufficient samples to allow Platelet-derived growth factor receptor (PDGFR-alpha and -beta expression to be correlated Of 22 patients only 7 samples available and only 5 yielded adequate tissue'}, {'measure': 'Determine Correlating Molecular Abnormalities in the Tumor With Response to Treatment', 'timeFrame': '3 years', 'description': 'Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined.\n\nComplete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids.\n\nPartial Response (PR): \\>/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone.\n\nStable/No Response: Does not qualify for CR, PR, or progression. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over Baseline (BL) if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).'}], 'primaryOutcomes': [{'measure': '6 Months - Progression-free Survival According to Response Evaluation Using Macdonald Criteria', 'timeFrame': 'At 6 months', 'description': 'The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (magnetic resonance imaging \\[MRI\\]) and clinical features\n\n1: complete response; 2: partial response; 3:stable disease; 4:progression\n\nComplete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved\n\nPartial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved\n\nStable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable\n\nProgression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival According to Response Evaluation Using Macdonald Criteria', 'timeFrame': '3 years', 'description': 'The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features\n\n1: complete response; 2: partial response; 3:stable disease; 4:progression\n\nComplete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved\n\nPartial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved\n\nStable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable\n\nProgression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration'}, {'measure': 'Toxicity as Assessed by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 2.0', 'timeFrame': 'Up to 5 years after completion of study treatment', 'description': 'percentage of patients who had grade 3 or grade 4 adverse events'}, {'measure': 'Tumor Response as Assessed by MRI Using Macdonald Criteria', 'timeFrame': 'Up to 5 years', 'description': 'The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features\n\n1: complete response; 2: partial response; 3:stable disease; 4:progression\n\nComplete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved\n\nPartial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved\n\nStable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable\n\nProgression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration'}, {'measure': 'Concentration (Steady State) of Imatinib During Cycle One (Pharmacokinetics)', 'timeFrame': 'pre dosing on day 8 and 24 hour dosing day 8 of Pre-dosing Day 9', 'description': 'Blood collected before and at 1,2,4 ad 24 hours after ingestion of imatinib on day 8 of cycle 1\n\nresult is the measurement of the before dosing on day 8 (trough level) and the 24 hour dosing day 8'}, {'measure': 'Determine Survival for Patients Treated With Imatinib Mesylate', 'timeFrame': '3 years', 'description': 'survival determined from start of treatment to date of death'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Adult Grade I Meningioma', 'Adult Grade II Meningioma', 'Adult Grade III Meningioma', 'Adult Meningeal Hemangiopericytoma', 'Adult Meningioma', 'Recurrent Adult Brain Tumor']}, 'descriptionModule': {'briefSummary': 'Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent meningioma. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. Determine the efficacy of imatinib mesylate, in terms of 6-month progression-free survival, of patients with recurrent meningioma.\n\nSECONDARY OBJECTIVES I. Determine the response rate and overall survival of patients treated with this drug.\n\nII. Evaluate the safety profile of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients. IV. Develop exploratory data concerning surrogate markers of of angiogenic activity in vivo using functional neuro-imaging studies and in vitro assays of serum angiogenic peptides of this drug in these patients.\n\nV. Develop exploratory data concerning evidence of platelet-derived growth factor (PDGF) inhibition in tumor specimens taken from patients undergoing surgery VI. Develop exploratory data correlating molecular abnormalities in the tumor with response in patients treated with this drug.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to concurrent use of enzyme-inducing antiepileptic drugs (yes vs no), histology (benign vs atypical or malignant), neurofibromatosis positivity (yes vs no), and preoperative candidacy (yes vs no).\n\nPatients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months.\n\nPROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study within 8-12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed meningioma\n\n * Benign, malignant, or atypical disease\n * Neurofibromatosis (NF) type 1 or 2 allowed\n * Hemangiopericytoma allowed\n* Unequivocal evidence of tumor recurrence or progression by MRI or CT scan (on steroid dosage that is stable for at least 5 days)\n* Evaluable residual disease by MRI or CT scan if previously treated with surgical resection for recurrent or progressive disease\n* Newly diagnosed recurrent disease that requires surgical debulking allowed\n* Prior standard external-beam radiotherapy, interstitial brachytherapy, or gamma-knife radiosurgery allowed provided disease has progressed since completion of therapy\n\n * Patients who have had prior brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis based upon positron-emission tomography or thallium scanning, magnetic resonance spectroscopy, or surgical documentation\n* Patients with a history of NF may have other stable Central Nervous System (CNS) tumors (e.g., schwannoma, acoustic neuroma, or ependymoma) provided those lesions have been stable in size for the past 6 months\n* Performance status - Karnofsky 60-100%\n* More than 8 weeks\n* Absolute neutrophil count at least 2,000/mm\\^3\n* Platelet count at least 120,000/mm\\^3\n* Hemoglobin at least 10 g/dL (transfusions allowed)\n* No bleeding disorders\n* Bilirubin less than 2 times upper limit of normal (ULN)\n* Serum glutamic oxaloacetic transaminase (SGOT) less than 2 times ULN\n* Prothrombin Time (PT), Partial thromboplastin time (PTT), and International normalized Ratio (INR) no greater than 1.5 times ULN\n* Creatinine less than 1.5 mg/dL\n* Creatinine clearance at least 60 mL/min\n* No deep venous or arterial thrombosis within the past 6 weeks\n* No pulmonary embolism within the past 6 weeks\n* No serious active infection\n* No prior intracranial hemorrhage\n* No concurrent disease that would obscure toxicity or dangerously alter drug metabolism\n* No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless the patient is in complete remission and off all therapy for that disease for at least 3 years\n* No other significant medical illness that would preclude study participation\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective barrier contraception during and for 3 months after study participation\n* At least 1 week since prior interferon or thalidomide\n* No concurrent immunotherapy\n* Concurrent epoetin alfa allowed\n* At least 4 weeks since prior cytotoxic chemotherapy\n* At least 2 weeks since prior vincristine\n* At least 6 weeks since prior nitrosoureas\n* At least 3 weeks since prior hydroxyurea or procarbazine\n* No concurrent chemotherapy\n* At least 1 week since prior tamoxifen\n* No concurrent hormonal therapy\n* At least 4 weeks since prior radiotherapy\n* No concurrent radiotherapy\n* Recovered from prior surgery\n* Recovered from all prior therapy\n* At least 1 week since prior noncytotoxic therapy (e.g., isotretinoin) except radiosensitizers\n* At least 2 weeks since prior drugs that affect hepatic metabolism\n* At least 4 weeks since prior investigational agents\n* No concurrent warfarin (heparin or low-molecular weight heparin allowed)\n* No other concurrent investigational agents\n* No concurrent acetaminophen of more than 500 mg/day\n* No other concurrent anticancer therapy'}, 'identificationModule': {'nctId': 'NCT00045734', 'briefTitle': 'Imatinib Mesylate in Treating Patients With Recurrent Meningioma', 'nctIdAliases': ['NCT00069667'], 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase II Trial of STI571 (NSC 716051) in Patients With Recurrent Meningioma', 'orgStudyIdInfo': {'id': 'NCI-2012-02495'}, 'secondaryIdInfos': [{'id': 'NABTC-0108'}, {'id': 'U01CA062399', 'link': 'https://reporter.nih.gov/quickSearch/U01CA062399', 'type': 'NIH'}, {'id': 'CDR0000257267', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (imatinib mesylate)', 'description': 'Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nOther: pharmacological study/ laboratory biomarker analysis', 'interventionNames': ['Drug: imatinib mesylate', 'Other: laboratory biomarker analysis', 'Other: pharmacological study']}], 'interventions': [{'name': 'imatinib mesylate', 'type': 'DRUG', 'otherNames': ['CGP 57148', 'Gleevec', 'Glivec'], 'description': 'Given orally', 'armGroupLabels': ['Treatment (imatinib mesylate)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (imatinib mesylate)']}, {'name': 'pharmacological study', 'type': 'OTHER', 'otherNames': ['pharmacological studies'], 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (imatinib mesylate)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20814', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Cancer Institute Neuro-Oncology Branch', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Patrick Wen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North American Brain Tumor Consortium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}