Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-27 @ 8:23 AM
Study NCT ID:
NCT00597402
Status:
COMPLETED
Last Update Posted:
2014-05-07
First Post:
2008-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Avastin in Combination With Radiation (XRT) & Temozolomide, Followed by Avastin, Temozolomide and Irinotecan for Glioblastoma (GBM) and Gliosarcomas
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D018316', 'term': 'Gliosarcoma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'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': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000077204', 'term': 'Temozolomide'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D000077146', 'term': 'Irinotecan'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'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'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'annick.desjardins@duke.edu', 'phone': '9196846173', 'title': 'Annick Desjardins, MD, FRCPC', 'organization': 'Duke University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '55 months', 'description': 'Adverse events collected using Common Terminology Criteria for Adverse Events (CTCAE) v.3.0 and converted to v.4.0 for ClinicalTrials.gov entry.', 'eventGroups': [{'id': 'EG000', 'title': 'Avastin, Radiation, Temozolomide, and Irinotecan', 'description': 'Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.\n\nFollowing completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)', 'otherNumAtRisk': 125, 'otherNumAffected': 45, 'seriousNumAtRisk': 125, 'seriousNumAffected': 35}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastrointestinal disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Upper gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sudden death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bone infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infections and infestations - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infections and infestations - Other, specify: Infecti', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Treatment related secondary malignancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cerebrospinal fluid leakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cognitive disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Intracranial hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '16-month Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Avastin, Radiation, Temozolomide, and Irinotecan', 'description': 'Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.\n\nFollowing completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)'}], 'classes': [{'categories': [{'measurements': [{'value': '64.8', 'groupId': 'OG000', 'lowerLimit': '55.7', 'upperLimit': '72.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '16 months', 'description': 'Percentage of participants surviving sixteen months from the start of study treatment. OS was defined as the time from the date of study treatment initiation to the date of death due to any cause.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'SECONDARY', 'title': '12-month Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Avastin, Radiation, Temozolomide, and Irinotecan', 'description': 'Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.\n\nFollowing completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)'}], 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'groupId': 'OG000', 'lowerLimit': '54.1', 'upperLimit': '71.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percentage of participants surviving twelve months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Experiencing a Central Nervous System (CNS) Hemorrhage or a Systemic Hemorrhage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Avastin, Radiation, Temozolomide, and Irinotecan', 'description': 'Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.\n\nFollowing completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)'}], 'classes': [{'title': 'Gr.2 Central Nervous System (CNS) Hemorrhage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Gr.3 Central Nervous System (CNS) Hemorrhage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Gr.4 Central Nervous System (CNS) Hemorrhage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Gr.5 Central Nervous System (CNS) Hemorrhage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Gr.2 Systemic Hemorrhage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Gr.3 Systemic Hemorrhage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Gr.4 Systemic Hemorrhage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Gr.5 Systemic Hemorrhage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '55 months', 'description': 'Number of times a CNS hemorrhage or systemic hemorrhage was experienced', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Experiencing a Grade ≥ 4 Hematologic or Grade ≥ 3 Non-hematologic Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Avastin, Radiation, Temozolomide, and Irinotecan', 'description': 'Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.\n\nFollowing completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)'}], 'classes': [{'title': 'Grade ≥ 4 Hematologic Toxicities', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Grade ≥3 Non-hematologic Toxicities', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '55 months', 'description': 'Number of times a grade ≥ 4 hematologic or grade ≥ 3 non-hematologic toxicity was experienced', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Avastin, Radiation, Temozolomide, and Irinotecan', 'description': 'Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.\n\nFollowing completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Avastin, Radiation, Temozolomide, and Irinotecan', 'description': 'Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.\n\nFollowing completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.6', 'spread': '12.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-22', 'studyFirstSubmitDate': '2008-01-10', 'resultsFirstSubmitDate': '2012-12-12', 'studyFirstSubmitQcDate': '2008-01-17', 'lastUpdatePostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-12', 'studyFirstPostDateStruct': {'date': '2008-01-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '16-month Overall Survival (OS)', 'timeFrame': '16 months', 'description': 'Percentage of participants surviving sixteen months from the start of study treatment. OS was defined as the time from the date of study treatment initiation to the date of death due to any cause.'}], 'secondaryOutcomes': [{'measure': '12-month Progression-free Survival (PFS)', 'timeFrame': '12 months', 'description': 'Percentage of participants surviving twelve months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.'}, {'measure': 'Number of Patients Experiencing a Central Nervous System (CNS) Hemorrhage or a Systemic Hemorrhage', 'timeFrame': '55 months', 'description': 'Number of times a CNS hemorrhage or systemic hemorrhage was experienced'}, {'measure': 'Number of Patients Experiencing a Grade ≥ 4 Hematologic or Grade ≥ 3 Non-hematologic Toxicity', 'timeFrame': '55 months', 'description': 'Number of times a grade ≥ 4 hematologic or grade ≥ 3 non-hematologic toxicity was experienced'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Avastin', 'Bevacizumab', 'Temozolomide', 'Temodar', 'Irinotecan', 'Camptosar', 'GBM', 'Glioblastoma Multiforme', 'Gliosarcoma', 'Brain tumor', 'Glioma', 'New GBM', 'Newly diagnosed GBM or gliosarcoma malignant brain tumor'], 'conditions': ['Glioblastoma', 'Gliosarcoma', 'Brain Tumor']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cancer.duke.edu/btc/', 'label': 'The Preston Robert Tisch Brain Tumor Center at DUKE'}]}, 'descriptionModule': {'briefSummary': 'Primary objective: To use overall survival to assess the efficacy of the combination of radiation therapy, temozolomide and Avastin followed by Avastin, temozolomide, and irinotecan in the treatment of grade IV malignant glioma patients following surgical resection.\n\nSecondary objective: To determine the progression-free survival following the combination of radiation therapy, temozolomide and Avastin followed by Avastin, temozolomide, and irinotecan.\n\nExploratory Objective: To explore the relationship between biomarkers and outcome (overall survival and progression-free survival) among patients with grade IV malignant glioma treated with radiation therapy, temozolomide and Avastin followed by Avastin, temozolomide, and irinotecan.\n\nTo describe the toxicity of radiation therapy,temozolomide and Avastin followed by Avastin, temozolomide, and irinotecan.', 'detailedDescription': 'The standard of care for grade IV gliomas is radiation therapy with daily temozolomide, followed by 6 months of temozolomide. The majority of patients progress and die of their tumor. Many glioma patients are resistant to temozolomide because the tumors have high O(6)-methylguanine-DNA methyltransferase (MGMT), conferring resistance. Irinotecan is synergistic with temozolomide, and the combination may overcome high MGMT. Vascular endothelial growth factor (VEGF) is present on the cell surface and around malignant gliomas. It appears that the presence of vascular endothelial growth factor is a prognostic growth factor with more VEGF expression correlating with a poor prognosis. Monoclonal antibodies to VEGF have inhibited growth of malignant gliomas in a mouse xenograft. Avastin is a humanized monoclonal immunoglobulin G (IGG) 1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor. The combination of Avastin and irinotecan was safe and demonstrated high activity against recurrent malignant gliomas. The combination of Avastin, temozolomide, and irinotecan as the initial therapy may maximize the chance for long-term survival. There are other studies completed or ongoing for newly diagnosed glioblastoma (GBM) patients, including a Radiation Therapy Oncology Group (RTOG) study that added irinotecan to temozolomide following standard radiation therapy and temozolomide, and a University of California, Los Angeles (UCLA) study that added Avastin to standard radiation therapy and temozolomide followed by Avastin and temozolomide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have histologically confirmed diagnosis of World Health Organization (WHO) grade IV primary malignant glioma (glioblastoma multiforme or gliosarcoma). Patients have to be within 4 weeks of the last major surgical procedure.\n* Age \\> 18 years.\n* An interval of at least 2 weeks and not \\> 6 weeks between prior major surgical procedure and study enrollment.\n* No prior radiotherapy or chemotherapy for a brain tumor\n* Karnofsky ≥ 60 percent.\n* Hemoglobin ≥ 9.0 g/deciliter (dl), absolute neutrophil count (ANC) ≥ 1,500 cells/ microliter, platelets ≥ 125,000 cells/microliter.\n* Serum creatinine ≤ 1.5 mg/dl, serum serum glutamic-oxaloacetic transaminase (SGOT) and bilirubin ≤ 1.5 times upper limit of normal (ULN).\n* For patients on corticosteroids, they must be on a stable or decreasing dose for 1 week prior to entry, and the dose should not be escalated over entry dose level, if clinically possible.\n* Signed informed consent approved by the Institutional Review Board\n* No evidence of \\> grade 1 central nervous system (CNS) hemorrhage on the baseline MRI or CT scan.\n* If sexually active, patients will take contraceptive measures for the duration of treatment as stated in the informed consent.\n\nExclusion Criteria:\n\n* Pregnancy or breast feeding.\n* Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids.\n* Active infection requiring intravenous (IV) antibiotics.\n* Prior treatment with radiotherapy or chemotherapy for a brain tumor, irrespective of the grade of the tumor.\n* Evidence of \\> grade 1 CNS hemorrhage on baseline MRI on CT scan.\n\nAvastin-Specific Concerns:\n\nSubjects meeting any of the following criteria are ineligible for study entry:\n\n* Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study\n* Blood pressure of 150/100 mmHg\n* Unstable angina\n* New York Heart Association (NYHA) Grade II or greater congestive heart failure\n* History of myocardial infarction within 6 months\n* History of stroke within 6 months\n* Clinically significant peripheral vascular disease\n* Evidence of bleeding diathesis\n* Coagulopathy (prothrombin time (PT) or partial thromboplastin time (PTT) \\>1.5x normal or a history of \\> three grade 2 or greater hemorrhages)\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to first Avastin infusion during XRT/Temodar or anticipation of need for major surgical procedure during the course of the study\n* Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to first Avastin infusion during XRT/Temodar\n* Pregnant (positive pregnancy test) or lactating\n* Urine protein \\>1.0 + at screening\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to first Avastin infusion during XRT/Temodar\n* Serious, non-healing wound, ulcer, or bone fractures.\n* Inability to comply with study and/or follow-up procedures.'}, 'identificationModule': {'nctId': 'NCT00597402', 'briefTitle': 'Avastin in Combination With Radiation (XRT) & Temozolomide, Followed by Avastin, Temozolomide and Irinotecan for Glioblastoma (GBM) and Gliosarcomas', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Avastin in Combination With Radiation and Temozolomide, Followed by Avastin, Temozolomide and Irinotecan for Glioblastoma Multiformes and Gliosarcomas', 'orgStudyIdInfo': {'id': 'Pro00000458'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Avastin, radiation, temozolomide, and irinotecan', 'interventionNames': ['Drug: Avastin', 'Drug: Temozolomide', 'Radiation: Radiation Therapy (XRT)', 'Drug: Irinotecan']}], 'interventions': [{'name': 'Avastin', 'type': 'DRUG', 'otherNames': ['Bevacizumab'], 'description': 'Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury. Following completion of XRT, patients will receive treatment that includes 6 cycles of Avastin, beginning a minimum of 14 days after last XRT.', 'armGroupLabels': ['Avastin, radiation, temozolomide, and irinotecan']}, {'name': 'Temozolomide', 'type': 'DRUG', 'otherNames': ['Temodar'], 'description': 'Daily temozolomide 75 mg/m2/day for 6.5 weeks of radiation treatment. Following completion of XRT, patients will receive treatment including temozolomide 200 mg/m2/day on the 1st 5 days of each 28-day cycle.', 'armGroupLabels': ['Avastin, radiation, temozolomide, and irinotecan']}, {'name': 'Radiation Therapy (XRT)', 'type': 'RADIATION', 'description': 'Treatment with standard XRT (radiation) for 6.5 weeks.', 'armGroupLabels': ['Avastin, radiation, temozolomide, and irinotecan']}, {'name': 'Irinotecan', 'type': 'DRUG', 'otherNames': ['CPT-11', 'Camptosar'], 'description': 'Following completion of XRT, patients will receive 6 cycles of treatment that includes irinotecan. Beginning a minimum of 14 days after last XRT, the irinotecan dose will depend on whether the patient is on enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED: 125 mg/m2.)', 'armGroupLabels': ['Avastin, radiation, temozolomide, and irinotecan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Health System', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Annick Desjardins, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, {'name': 'Schering-Plough', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}