Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:55 PM
Study NCT ID:
NCT00393094
Status:
TERMINATED
Last Update Posted:
2012-07-13
First Post:
2006-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bevacizumab and Irinotecan to Treat Brain Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D018450', 'term': 'Disease Progression'}, {'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'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': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hfine@mail.nih.gov', 'phone': '301-402-6383', 'title': 'Howard A. Fine, M.D.', 'organization': 'National Cancer Institute, National Institutes of Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Evaluating combination therapy, 19 GBM patients were enrolled. Accrual was terminated after it became clear that we could not reach our efficacy rule of 3 or more of 29 patients responding. The AG arm never fully accrued before the study was closed.'}}, 'adverseEventsModule': {'timeFrame': '23 months', 'eventGroups': [{'id': 'EG000', 'title': 'Enrollment Until Prior to Treatment', 'otherNumAtRisk': 30, 'otherNumAffected': 27, 'seriousNumAtRisk': 30, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'AST, SGOT (serum glutamic oxaloacetic transaminase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Alkaline phosphatase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bilirubin (hyperbilirubinemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue (asthenia, lethargy, malaise)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Leukocytes (total WBC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutrophils/granulocytes (ANC/AGC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 13, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: head/headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Phosphate, serum-low (hypophosphatemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 12, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cytokine release syndrome/acute infusion reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage, central nervous system (CNS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage, genitourinary (GU) retroperitoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage, pulmonary/upper respiratory: Nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hair loss/alopecia (scalp or body)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hiccoughs (hiccups, singultus)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Death not associated with CTCAE term: Death Progression NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neurology: Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombosis/embolism (vascular access-related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Leukocytes (total white blood count (WBC))', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutrophils/granulocytes (absolute neutrophil count (ANC)/absolute granulocyte count (AGC))', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'DIC (disseminated intravascular coagulation)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Radiographic Response Rate (Malignant Glioma Participants)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrollment Until Prior to Treatment'}], 'classes': [{'title': 'Partial response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Complete response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Stable disease', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}]}]}, {'title': 'Progressive disease', 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '23 months (date of first enrollment to 1 month after last progression)', 'description': 'Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is per protocol (N=30), excluding the 1 patient who progressed and withdrew consent prior to any treatment but after enrollment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Toxicity as Measured by The National Cancer Institute (NCI) Common Toxicity Criteria v. 3.0.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrollment Until Prior to Treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '23 months (date of first enrollment to 1 month after last progression)', 'description': 'Here is the number of participants with any toxicity, defined as any adverse events possibly, probably or definitely related to the investigational drugs. For the detailed list of investigational new drug (IND)-related toxicities and other serious adverse events, see the adverse event module.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is per protocol (N=30), excluding the 1 patient who progressed and withdrew consent prior to any treatment but after enrollment.'}, {'type': 'PRIMARY', 'title': 'Radiographic Response Rate (Anaplastic Glioma Participants)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab & Irinotecan Anaplastic Glioma Pts: Enrollment', 'description': 'Bevacizumab - 10 mg/kg intravenous injection Irinotecan - 125 mg/m\\^2 if patient is on a non-enzyme inducing anti-epileptic drugs 340 mg/m\\^2 if patient is on enzyme inducing anti-epileptic drugs every two weeks on a 4 week cycle Anaplastic gliomas are classified by the World Health Organization (WHO) as grade 3 malignant tumors and include the anaplastic astrocytoma, anaplastic oligodendroglioma, and anaplastic oligoastrocytoma or mixed glioma.'}], 'classes': [{'title': 'Partial response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Complete response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Stable disease', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Progressive disease', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '23 months (date of first enrollment to 1 month after last progression)', 'description': 'Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is per protocol (N=30), excluding the 1 patient who progressed and withdrew consent prior to any treatment but after enrollment.'}, {'type': 'PRIMARY', 'title': 'Radiographic Response Rate (Glioblastoma Multiforme Participants)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab & Irinotecan Glioblastoma Multiforme: Enrollment', 'description': 'Bevacizumab - 10 mg/kg intravenous injection Irinotecan - 125 mg/m\\^2 if patient is on a non-enzyme inducing anti-epileptic drugs 340 mg/m\\^2 if patient is on enzyme inducing anti-epileptic drugs every two weeks on a 4 week cycle Glioblastoma multiforme- is a fast growing type of central nervous system tumor that forms from glial (supportive) tissue of the brain and spinal cord and has cells that look very different from normal cells. Glioblastoma multiforme usually occurs in adults and affects the brain more often than the spinal cord. Also called GBM, glioblastoma, and grade IV astrocytoma.'}], 'classes': [{'title': 'Partial response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Complete response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Stable disease', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Progressive disease', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '23 months (date of first enrollment to 1 month after last progression)', 'description': 'Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enrollment Until Prior to Treatment'}], 'periods': [{'title': 'Period1Bevacizumab & Irinotecan Patients', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Disease progression before treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Disease Progression After Trtmt: Onstudy', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Refused further treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Enrollment Until Prior to Treatment'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.96', 'spread': '10.39', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'whyStopped': 'Terminated due to the limitations of accrual.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-06', 'studyFirstSubmitDate': '2006-10-25', 'resultsFirstSubmitDate': '2012-03-27', 'studyFirstSubmitQcDate': '2006-10-25', 'lastUpdatePostDateStruct': {'date': '2012-07-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-25', 'studyFirstPostDateStruct': {'date': '2006-10-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic Response Rate (Malignant Glioma Participants)', 'timeFrame': '23 months (date of first enrollment to 1 month after last progression)', 'description': 'Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.'}, {'measure': 'Number of Participants With Toxicity as Measured by The National Cancer Institute (NCI) Common Toxicity Criteria v. 3.0.', 'timeFrame': '23 months (date of first enrollment to 1 month after last progression)', 'description': 'Here is the number of participants with any toxicity, defined as any adverse events possibly, probably or definitely related to the investigational drugs. For the detailed list of investigational new drug (IND)-related toxicities and other serious adverse events, see the adverse event module.'}, {'measure': 'Radiographic Response Rate (Anaplastic Glioma Participants)', 'timeFrame': '23 months (date of first enrollment to 1 month after last progression)', 'description': 'Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.'}, {'measure': 'Radiographic Response Rate (Glioblastoma Multiforme Participants)', 'timeFrame': '23 months (date of first enrollment to 1 month after last progression)', 'description': 'Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Brain Tumor', 'Chemotherapy', 'Progression', 'Radiotherapy', 'Antiangiogenesis', 'Glioma'], 'conditions': ['High-Grade Gliomas']}, 'referencesModule': {'references': [{'pmid': '3107130', 'type': 'BACKGROUND', 'citation': 'Barker D, Wright E, Nguyen K, Cannon L, Fain P, Goldgar D, Bishop DT, Carey J, Baty B, Kivlin J, et al. Gene for von Recklinghausen neurofibromatosis is in the pericentromeric region of chromosome 17. Science. 1987 May 29;236(4805):1100-2. doi: 10.1126/science.3107130.'}, {'pmid': '3001489', 'type': 'BACKGROUND', 'citation': 'Bigner SH, Bjerkvig R, Laerum OD. DNA content and chromosomal composition of malignant human gliomas. Neurol Clin. 1985 Nov;3(4):769-84.'}, {'pmid': '4093991', 'type': 'BACKGROUND', 'citation': 'Moss AR. Occupational exposure and brain tumors. J Toxicol Environ Health. 1985;16(5):703-11. doi: 10.1080/15287398509530780.'}, {'pmid': '19114704', 'type': 'BACKGROUND', 'citation': 'Kreisl TN, Kim L, Moore K, Duic P, Royce C, Stroud I, Garren N, Mackey M, Butman JA, Camphausen K, Park J, Albert PS, Fine HA. Phase II trial of single-agent bevacizumab followed by bevacizumab plus irinotecan at tumor progression in recurrent glioblastoma. J Clin Oncol. 2009 Feb 10;27(5):740-5. doi: 10.1200/JCO.2008.16.3055. Epub 2008 Dec 29.'}, {'pmid': '21865400', 'type': 'RESULT', 'citation': 'Kreisl TN, Zhang W, Odia Y, Shih JH, Butman JA, Hammoud D, Iwamoto FM, Sul J, Fine HA. A phase II trial of single-agent bevacizumab in patients with recurrent anaplastic glioma. Neuro Oncol. 2011 Oct;13(10):1143-50. doi: 10.1093/neuonc/nor091. Epub 2011 Aug 24.'}], 'seeAlsoLinks': [{'url': 'http://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2006-C-0250.html', 'label': 'NIH Clinical Center Detailed Web Page'}, {'url': 'http://www.nlm.nih.gov/medlineplus/', 'label': 'Medline Plus'}, {'url': 'http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp', 'label': 'Drug Information'}, {'url': 'http://www.clinicaltrials.gov/ct2/info/fdalinks', 'label': 'US FDA Resources'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\n* Bevacizumab is a genetically engineered antibody that blocks the growth of new blood vessels in tumors. It has shown activity against human brain tumors in laboratory tests and human clinical trials.\n* Irinotecan causes damage to the deoxyribonucleic acid (DNA) in cancer cells so that the cells cannot reproduce or repair themselves. It is approved for treating patients with colorectal cancer.\n* Bevacizumab and irinotecan in combination are more effective against colon cancer than either drug alone.\n\nObjectives:\n\n* To determine the safety of bevacizumab and irinotecan and any side effects associated with the combination of the two drugs when given to patients with high grade gliomas.\n* To determine if the combination of bevacizumab and irinotecan can help patients with brain tumors that have grown after treatment with bevacizumab alone.\n\nEligibility:\n\n-Patients 18 years of age and older who have been treated on National Cancer Institute (NCI) trial 06-C-0064 (NCT00271609), "Bevacizumab Alone for Recurrent Gliomas," and whose tumor has progressed.\n\nDesign:\n\nParticipants receive infusions of bevacizumab and irinotecan through a vein once every 2 weeks in 4-week treatment cycles, plus the following procedures:\n\n* History, physical and neurological examinations every 2 weeks for the first treatment cycle and then every 4 weeks\n* Magnetic Resonance Imaging (MRI) scan of the head every 4 weeks.\n* Routine lab every week.\n* Quality-of-life questionnaire every 4 weeks', 'detailedDescription': 'Background:\n\n* Bevacizumab is a humanized IgG1 monoclonal antibody (MAb) that binds all biologically active isoforms of human vascular endothelial growth factor (VEGF, or VEGF-A) with high affinity (kd = 1.1 nM ). The antibody consists of a human IgG1 framework and the antigen-binding complementarity-determining regions from the murine anti-VEGF MAb A.4.6.1.\n* Irinotecan is a semisynthetic derivative of camptothecin that possesses greater aqueous solubility, greater in vitro and in vivo activity, and is associated with less severe and more predictable toxicity than camptothecin.\n* We now propose treating patients whose tumors progress on our bevacizumab alone protocol with the combination of bevacizumab with irinotecan. We believe that this trial design has significant power to detect a true synergistic effect between the two agents given that the single agent activity of irinotecan is so low in patients with recurrent malignant gliomas (2-5% response rate) and the patients being treated on this trial will have tumors that have already progressed through bevacizumab.\n\nObjective:\n\n* To establish data and safety regarding the anti-tumor activity of bevacizumab plus irinotecan in patients with recurrent high-grade gliomas that have progressed on bevacizumab alone as determined by objective radiographic response rate.\n* To determine the 6 month progression-free survival of treated patients and to characterize the pattern of changes in the number of endothelial progenitor cells over time and across patients.\n* To obtain preliminary data regarding how response to treatment (stable disease or radiographic response) effects monthly measurements of quality of life while on study.\n\nEligibility:\n\n* Patients must have been treated on the National Cancer Institute (NCI) trial 06-C-0064; bevacizumab alone for recurrent gliomas and now have evidence for tumor progression by magnetic resonance imaging (MRI) scan.\n* Patients with histologically proven intracranial malignant glioma.\n\nDesign:\n\n-Patients will be treated with bevacizumab by intravenous injection at a dose of 10mg/kg and irinotecan at a dose of 125 mg/m\\^2 for patients on non-enzyme-inducing anti-epileptic drugs (NEIAED) and 340 mg/m\\^2 for patients on enzyme-inducing anti-epileptic drugs (EIAED) every two weeks on a 4-week cycle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "* INCLUSION CRITERIA:\n\nPatients must have been treated on the National Cancer Institute (NCI) trial 06-C-0064 (NCT00271609); bevacizumab alone for recurrent gliomas and now have evidence for tumor progression by magnetic resonance imaging (MRI) scan.\n\nPatients with histologically proven intracranial malignant glioma will be eligible for this protocol. Malignant glioma include glioblastoma multiforme (GBM), gliosarcoma, anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma NOS (not otherwise specified).\n\nPatients must have evidence for tumor progression by MRI or computed tomography (CT) scan. This scan should be performed within 14 days prior to registration and on a fixed dose of steroids for at least 5 days. If the steroid dose is increased between the date of imaging and registration a new baseline magnetic resonance (MR)/CT is required. The same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for tumor measurement.\n\nPatients must be greater than or equal to 18 years old, and with a life expectancy greater than 8 weeks.\n\nAll patients or their previously designated durable power of attorney (DPA) (if the patient is deemed by the treating physician to be impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable) must sign an informed consent indicating that they are aware of the investigational nature of this study.\n\nPatients must have a Karnofsky performance status of greater than or equal to 60.\n\nPatients must not be more than 4 weeks since their last bevacizumab treatment and may have received no form of treatment (i.e. radiation, chemotherapy, surgery, investigational therapy) for their progressive tumor between their last bevacizumab treatment and enrollment of this companion trial.\n\nPatients must have adequate bone marrow function (white blood cell (WBC) greater than or equal 3,000/microl, absolute neutrophil count (ANC) greater than or equal to1,500/mm\\^3, platelet count of greater than to or equal 100,000/mm\\^3), and hemoglobin greater than or equal to 10 gm/dl), adequate liver function (serum glutamic oxaloacetic transaminase (SGOT) and bilirubin less than 2.5 times upper limits of normal (ULN)), and adequate renal function (creatinine less than 1.5 mg/dL and/or creatinine clearance greater than or equal to 60 cc/min) before starting therapy. These tests must be performed within 14 days prior to registration. Eligibility level for hemoglobin may be reached by transfusion.\n\nPatients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patients' ability to tolerate this therapy.\n\nThis study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. No exclusion to this study will be based on race.\n\nUrine protein should be screened by dipstick or urine analysis for Urine Protein Creatinine (UPC) ratio. For proteinuria greater than or equal to 1+ or urine protein:creatinine UPC ratio greater than 1.0, 24-hour urine protein should be obtained and the level should be less than 1000 mg for patient enrollment.\n\nSubjects must be willing and able to practice adequate contraception.\n\nEXCLUSION CRITERIA:\n\nConcurrent use of other standard chemotherapeutics or investigative agents.\n\nPatients who have an active infection.\n\nPregnant (positive pregnancy test) or nursing women. Both fertile men and women must agree to use adequate contraceptive measures during study therapy and for at least 6 months after the completion of bevacizumab therapy.\n\nConcurrent anti-coagulation or anti-platelet medication (including aspirin, non-steroidal anti-inflammatories, cyclooxygenase-2 (COX-2) inhibitors).\n\nSerious or non-healing wound, ulcer or bone fracture.\n\nHistory of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days.\n\nInvasive procedures defined as follows:\n\n* Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 1 therapy\n* Anticipation of need for major surgical procedures during the course of the study\n* Core biopsy within 7 days prior to day (D)1 therapy\n\nPatients with clinically significant cardiovascular disease:\n\n* History of cerebrovascular accident (CVA) within 6 months\n* Uncontrolled hypertension (greater than 150/100 mmHg)\n* Myocardial infarction or unstable angina within 6 months\n* New York heart association grade II or greater congestive heart failure\n* Serious cardiac arrhythmia requiring medication\n* Unstable angina pectoris\n* Clinically significant peripheral vascular disease\n\nClinical evidence of bleeding diathesis or coagulopathy.\n\nPatients with known hypersensitivity of Chinese hamster ovary cell products or other recombinant human antibodies."}, 'identificationModule': {'nctId': 'NCT00393094', 'briefTitle': 'Bevacizumab and Irinotecan to Treat Brain Tumors', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'A Phase II Trial of Bevacizumab and Irinotecan for Patients With Recurrent High-Grade Gliomas Immediately Following Tumor Progression After Treatment w/Bevacizumab Alone: A Companion Trial to NCI Study 06-C-0064 (NCT00271609)(Bevacizumab Alone for Recurrent Gliomas)', 'orgStudyIdInfo': {'id': '060250'}, 'secondaryIdInfos': [{'id': '06-C-0250'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bevacizumab & Irinotecan Patients', 'description': 'Bevacizumab - 10 mg/kg intravenous injection Irinotecan - 125 mg/m\\^2 if patient is on a non-enzyme inducing anti-epileptic drugs 340 mg/m\\^2 if patient is on enzyme inducing anti-epileptic drugs every two weeks on a 4 week cycle', 'interventionNames': ['Biological: Bevacizumab', 'Drug: Irinotecan hydrochloride']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'BIOLOGICAL', 'otherNames': ['rhuMAb VEGF'], 'description': '10 mg/kg intravenous injection', 'armGroupLabels': ['Bevacizumab & Irinotecan Patients']}, {'name': 'Irinotecan hydrochloride', 'type': 'DRUG', 'otherNames': ['irinotecan hydrochloride trihydrate', 'CPT-11', 'Camptosar'], 'description': '125 mg/m\\^2 if patient is on a non-enzyme inducing anti-epileptic drugs 340 mg/m\\^2 if patient is on enzyme inducing anti-epileptic drugs every two weeks on a 4 week cycle', 'armGroupLabels': ['Bevacizumab & Irinotecan Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center, 9000 Rockville Pike', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Howard A Fine, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute, National Institutes of Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'oldNameTitle': 'Howard A. Fine, M.D./National Cancer Institute', 'oldOrganization': 'National Institutes of Health'}}}}