Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-30 @ 5:23 AM
Study NCT ID:
NCT00112866
Status:
TERMINATED
Last Update Posted:
2017-06-14
First Post:
2005-06-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cilengitide in Treating Patients Who Are Undergoing Surgery for Recurrent or Progressive Glioblastoma Multiforme
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'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'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': 'C422910', 'term': 'Cilengitide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jfisher@jhmi.edu', 'phone': '410-955-8837', 'title': 'Mark Gilbert, MD', 'organization': 'Adult Brain Tumor Consortium (ABTC)'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Study closed early due to slow accrual. Molecular analyses evaluating alterations were planned for the study, unfortunately, majority of tumor samples were too small to do analysis and also there were unforeseen freezer issues.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Post-Operative 2000mg', 'description': 'Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.\n\ncilengitide: Given IV\n\ntherapeutic conventional surgery: Undergo tumor resection\n\npharmacological study: Correlative studies\n\nlaboratory biomarker analysis: Correlative studies', 'otherNumAtRisk': 26, 'otherNumAffected': 26, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Alanine aminotransferase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'leukocytes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'neutrophils', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '6m-Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Operative Treatment 2000mg', 'description': 'Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.\n\ncilengitide: Given IV\n\npharmacological study: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'progression within 6 months (26 weeks) of treatment', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED', 'populationDescription': '6months progression free survival based on the post surgical treatment. All patients received 2000mg post surgery. The pre-surgery dose was used for correlative purposes only. All patients received surgery and the doses pre-surgery have no relation to the primary objective.'}, {'type': 'SECONDARY', 'title': 'Changes in avb3 Integrin Expression on Tumor Cells and Endothelial Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I Pre-op (Low-dose Cilengitide) 500mg', 'description': 'Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)\n\nResection: All patients undergo tumor resection on day 0.\n\ncilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Group II Pre-op (High-dose Cilengitide) 2000mg', 'description': 'Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)\n\nResection: All patients undergo tumor resection on day 0.\n\ncilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection laboratory biomarker analysis: Correlative studies'}], 'timeFrame': 'Baseline and time of surgery', 'description': "Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.", 'reportingStatus': 'POSTED', 'populationDescription': 'Molecular analyses evaluating alterations after cilengitide treatments were planned as a component of this clinical trial, unfortunately, the majority of tumor samples were too small to do both measures of drug and molecular analysis or the sample was inadequate for both after removal of areas of necrosis and gliosis'}, {'type': 'SECONDARY', 'title': 'Changes in Vitronectin Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I Pre-op (Low-dose Cilengitide) 500mg', 'description': 'Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)\n\nResection: All patients undergo tumor resection on day 0.\n\ncilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Group II Pre-op (High-dose Cilengitide) 2000mg', 'description': 'Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)\n\nResection: All patients undergo tumor resection on day 0.\n\ncilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection laboratory biomarker analysis: Correlative studies'}], 'timeFrame': 'Baseline and time of surgery', 'description': "Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.", 'reportingStatus': 'POSTED', 'populationDescription': 'Molecular analyses evaluating alterations planned, unfortunately, majority of tumor samples were too small to do both measures of drug and molecular analysis or sample was inadequate for both after removal of areas of necrosis and gliosis'}, {'type': 'SECONDARY', 'title': 'Changes in Tumor Cell Apoptosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I Pre-op (Low-dose Cilengitide) 500mg', 'description': 'Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)\n\nResection: All patients undergo tumor resection on day 0.\n\ncilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Group II Pre-op (High-dose Cilengitide) 2000mg', 'description': 'Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)\n\nResection: All patients undergo tumor resection on day 0.\n\ncilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection\n\nlaboratory biomarker analysis: Correlative studies'}], 'timeFrame': 'Baseline and time of surgery', 'description': "Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.", 'reportingStatus': 'POSTED', 'populationDescription': 'Molecular analyses evaluating alterations planned, unfortunately, majority of tumor samples were too small to do both measures of drug and molecular analysis or sample was inadequate for both after removal of areas of necrosis and gliosis'}, {'type': 'SECONDARY', 'title': 'Changes in Tumor Cell Proliferation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I Pre-op (Low-dose Cilengitide) 500mg', 'description': 'Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)\n\nResection: All patients undergo tumor resection on day 0.\n\ncilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Group II Pre-op (High-dose Cilengitide) 2000mg', 'description': 'Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)\n\nResection: All patients undergo tumor resection on day 0.\n\ncilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection laboratory biomarker analysis: Correlative studies'}], 'timeFrame': 'Baseline and time of surgery', 'description': "Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.", 'reportingStatus': 'POSTED', 'populationDescription': 'Molecular analyses evaluating alterations planned, unfortunately, majority of tumor samples were too small to do both measures of drug and molecular analysis or sample was inadequate for both after removal of areas of necrosis and gliosis'}, {'type': 'SECONDARY', 'title': 'Changes in Endothelial Cell Apoptosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group II Pre-op (High-dose Cilengitide) 2000mg', 'description': 'Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)\n\nResection: All patients undergo tumor resection on day 0.\n\ncilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection laboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Group I Pre-op (Low-dose Cilengitide) 500mg', 'description': 'Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)\n\nResection: All patients undergo tumor resection on day 0.\n\ncilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection\n\nlaboratory biomarker analysis: Correlative studies'}], 'timeFrame': 'Baseline and up to 4 years', 'description': "Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.", 'reportingStatus': 'POSTED', 'populationDescription': 'Molecular analyses evaluating alterations planned, unfortunately, majority of tumor samples were too small to do both measures of drug and molecular analysis or sample was inadequate for both after removal of areas of necrosis and gliosis'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of EMD 121974', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I (Low-dose Cilengitide) 500mg', 'description': 'Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (High dose 2000mg)\n\nResection: All patients undergo tumor resection on day 0.\n\nPostoperative Treatment: Beginning within 2 weeks after surgery, all patients receive 2000mg high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.\n\ncilengitide: Given IV\n\ntherapeutic conventional surgery: Undergo tumor resection\n\npharmacological study: Correlative studies\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Group II High-dose Cilengitide) 2000mg', 'description': 'Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)\n\nResection: All patients undergo tumor resection on day 0.\n\nPostoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity\n\ncilengitide: Given IV\n\ntherapeutic conventional surgery: Undergo tumor resection\n\npharmacological study: Correlative studies\n\nlaboratory biomarker analysis: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '333', 'spread': '16.97', 'groupId': 'OG000'}, {'value': '386', 'spread': '184', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hour post concentration', 'description': '24 hour post dose concentration plasma, at time of resection', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6 of 8 and 7 of 11 plasma samples at the 500mg and 2000mg dose level respectively, were below the lower level of quantitation (LLOQ) Of the 15 samples in the low dose group only 8 were evaluable and 11 of the 15 for the high dose group. Samples were either damaged or too small for analysis.'}, {'type': 'SECONDARY', 'title': 'Tumor Tissue Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I (Low-dose Cilengitide) 500mg', 'description': 'Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)\n\nResection: All patients undergo tumor resection on day 0.\n\nPostoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.\n\ncilengitide: Given IV\n\ntherapeutic conventional surgery: Undergo tumor resection\n\npharmacological study: Correlative studies\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Group II (High-dose Cilengitide) 2000mg', 'description': 'Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)\n\nResection: All patients undergo tumor resection on day 0.\n\nPostoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity\n\ncilengitide: Given IV\n\ntherapeutic conventional surgery: Undergo tumor resection\n\npharmacological study: Correlative studies\n\nlaboratory biomarker analysis: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '919', 'spread': '1235', 'groupId': 'OG000'}, {'value': '1413', 'spread': '1335', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at time of surgery', 'description': 'a section of tumor of approximately 500mg will be snap frozen (immediately prepared and frozen) once removed from brain for analysis of the drug concentration in contrast -enhancing tumor.', 'unitOfMeasure': 'ng/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '8 500mg dose tissue samples and 10 2000mg dose tissue samples were either too small or had large areas of necrosis and gliosis to do analysis/evaluation'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-Operative Treatment 2000mg', 'description': 'Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.\n\ncilengitide: Given IV\n\ntherapeutic conventional surgery: Undergo tumor resection\n\npharmacological study: Correlative studies\n\nlaboratory biomarker analysis: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '16'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 year', 'description': 'Kaplan-meier curve', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall survival based on the post surgical treatment. All patients received 2000mg post surgery. The pre-surgery dose was used for correlative purposes only. All patients received surgery and the doses pre-surgery have no relation to the this objective.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Dose 500mg Group 1', 'description': 'Preoperative Treatment: Patients receive low dose cilengitide 500mg IV over 1 hour on days -8, -4, and -1.\n\nResection: All patients undergo tumor resection on day 0.\n\nPostoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide 2000mg IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.\n\ncilengitide: Given IV\n\ntherapeutic conventional surgery: Undergo tumor resection\n\npharmacological study: Correlative studies\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'FG001', 'title': 'High Dose 2000mg Group 2', 'description': 'Preoperative Treatment: Patients receive high-dose cilengitide 2000mg IV over 1 hour on days -8, -4, and -1.\n\nResection: All patients undergo tumor resection on day 0.\n\nPostoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.\n\ncilengitide: Given IV\n\ntherapeutic conventional surgery: Undergo tumor resection\n\npharmacological study: Correlative studies\n\nlaboratory biomarker analysis: Correlative studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'did not start treatment post-op', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Patients were enrolled from March 2005 through October 2006. Patients were recruited in the outpatient setting, however patients did need surgery for this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Dose 500mg Group 1', 'description': 'Preoperative Treatment: Patients receive low dose 500mg cilengitide IV over 1 hour on days -8, -4, and -1.\n\nResection: All patients undergo tumor resection on day 0.\n\nPostoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.\n\ncilengitide: Given IV\n\ntherapeutic conventional surgery: Undergo tumor resection\n\npharmacological study: Correlative studies\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'BG001', 'title': 'High Dose 2000mg Group 2', 'description': 'Preoperative Treatment: Patients receive high-dose 2000mg cilengitide IV over 1 hour on days -8, -4, and -1.\n\nResection: All patients undergo tumor resection on day 0.\n\nPostoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.\n\ncilengitide: Given IV\n\ntherapeutic conventional surgery: Undergo tumor resection\n\npharmacological study: Correlative studies\n\nlaboratory biomarker analysis: Correlative studies'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000', 'lowerLimit': '42', 'upperLimit': '63'}, {'value': '56', 'groupId': 'BG001', 'lowerLimit': '42', 'upperLimit': '68'}, {'value': '55', 'groupId': 'BG002', 'lowerLimit': '42', 'upperLimit': '68'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Histology - Glioblastoma', 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior Chemotherapy', 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior Immunotherapy', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior Radiotherapy', 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior Biopsy Only', 'classes': [{'title': 'yes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'no', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '26 patients evaluated for toxicity and efficacy. 1 patient deemed ineligible and 3 patients did not re-start treatment post surgery.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'due to poor accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-16', 'studyFirstSubmitDate': '2005-06-02', 'resultsFirstSubmitDate': '2016-10-07', 'studyFirstSubmitQcDate': '2005-06-02', 'lastUpdatePostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-16', 'studyFirstPostDateStruct': {'date': '2005-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall Progression Free Survival', 'timeFrame': '1 year', 'description': 'Kaplan-meier curve'}], 'primaryOutcomes': [{'measure': '6m-Progression-free Survival', 'timeFrame': '6 months', 'description': 'progression within 6 months (26 weeks) of treatment'}], 'secondaryOutcomes': [{'measure': 'Changes in avb3 Integrin Expression on Tumor Cells and Endothelial Cells', 'timeFrame': 'Baseline and time of surgery', 'description': "Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no."}, {'measure': 'Changes in Vitronectin Expression', 'timeFrame': 'Baseline and time of surgery', 'description': "Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no."}, {'measure': 'Changes in Tumor Cell Apoptosis', 'timeFrame': 'Baseline and time of surgery', 'description': "Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no."}, {'measure': 'Changes in Tumor Cell Proliferation', 'timeFrame': 'Baseline and time of surgery', 'description': "Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no."}, {'measure': 'Changes in Endothelial Cell Apoptosis', 'timeFrame': 'Baseline and up to 4 years', 'description': "Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no."}, {'measure': 'Plasma Concentration of EMD 121974', 'timeFrame': '24 hour post concentration', 'description': '24 hour post dose concentration plasma, at time of resection'}, {'measure': 'Tumor Tissue Concentrations', 'timeFrame': 'at time of surgery', 'description': 'a section of tumor of approximately 500mg will be snap frozen (immediately prepared and frozen) once removed from brain for analysis of the drug concentration in contrast -enhancing tumor.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Adult Giant Cell Glioblastoma', 'Adult Glioblastoma', 'Adult Gliosarcoma', 'Recurrent Adult Brain Tumor']}, 'descriptionModule': {'briefSummary': 'Cilengitide may stop the growth of glioblastoma multiforme by blocking blood flow to the tumor. Giving cilengitide before and after surgery may be an effective treatment for glioblastoma multiforme. This phase II trial is studying how well cilengitide works in treating patients who are undergoing surgery for recurrent or progressive glioblastoma multiforme.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Determine the 6-month progression-free survival rate in operative patients with recurrent or progressive glioblastoma multiforme treated with cilengitide.\n\nSECONDARY OBJECTIVES:\n\nI. Determine the safety and toxicity of this drug in these patients.\n\nOUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment groups for the preoperative treatment component.\n\nPreoperative Treatment Group I: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1.\n\nPreoperative Treatment Group II: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1.\n\nResection: All patients undergo tumor resection on day 0.\n\nPostoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed every 3 months.\n\nPROJECTED ACCRUAL: A total of 44 patients (22 per preoperative treatment group) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed intracranial glioblastoma multiforme (GBM)\n\n * Original diagnosis of low-grade glioma with subsequent histological confirmation of GBM allowed\n * Recurrent disease\n\n * Failed prior radiotherapy\n* Must require a surgical procedure (gross total or near gross total resection) for tumor removal\n* Performance status - Karnofsky 60-100%\n* White Blood Count (WBC) ≥ 3,000/mm\\^3\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Hemoglobin ≥ 10 g/dL (transfusion allowed)\n* Serum glutamic oxaloacetic transaminase (SGOT) \\< 2 times upper limit of normal (ULN)\n* Bilirubin \\< 2 times ULN\n* Creatinine \\< 1.5 mg/dL\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective barrier contraception during and for ≥ 2 weeks after study participation (for female patients) or for 3 months after study participation (for male patients)\n* No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix\n* No active infection\n* No other significant uncontrolled medical illness that would preclude study participation\n* At least 3 weeks since prior interferon\n* No prior cilengitide\n* No other prior targeted antiangiogenic treatment (e.g., vatalanib, SU5416, or thalidomide)\n* No concurrent anticancer immunotherapy\n* No concurrent routine prophylactic filgrastim (G-CSF)\n* At least 2 weeks since prior vincristine\n* At least 3 weeks since prior procarbazine\n* At least 6 weeks since prior nitrosoureas\n* No concurrent anticancer chemotherapy\n* At least 3 weeks since prior tamoxifen\n* No concurrent anticancer hormonal therapy\n* See Disease Characteristics\n* At least 4 weeks since prior radiotherapy\n* No concurrent anticancer radiotherapy\n* Recovered from all prior therapies\n* No more than 3 prior treatments for GBM (1 initial treatment; and treatment for 2 relapses)\n\n * For patients who received prior therapy for low-grade glioma, a subsequent surgical diagnosis of high-grade glioma is considered the first relapse\n* At least 4 weeks since prior investigational agents\n* At least 4 weeks since prior cytotoxic therapy\n* At least 3 weeks since other prior non-cytotoxic therapy (e.g., isotretinoin), except radiosensitizers\n* No other concurrent anticancer therapy\n* No other concurrent investigational agents'}, 'identificationModule': {'nctId': 'NCT00112866', 'briefTitle': 'Cilengitide in Treating Patients Who Are Undergoing Surgery for Recurrent or Progressive Glioblastoma Multiforme', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase II Trial of EMD 121974 for Recurrent Glioblastoma: A Clinical Trial With Tissue Correlates of Response', 'orgStudyIdInfo': {'id': 'NCI-2012-02653'}, 'secondaryIdInfos': [{'id': 'NCI-2012-02653', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000428409'}, {'id': 'NABTC-03-02', 'type': 'OTHER', 'domain': 'North American Brain Tumor Consortium'}, {'id': 'NABTC-03-02', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U01CA062399', 'link': 'https://reporter.nih.gov/quickSearch/U01CA062399', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (high-dose cilengitide) 2000mg', 'description': 'Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (High dose 2000mg)\n\nResection: All patients undergo tumor resection on day 0.\n\nPostoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: cilengitide', 'Procedure: therapeutic conventional surgery', 'Other: pharmacological study', 'Other: laboratory biomarker analysis']}, {'type': 'EXPERIMENTAL', 'label': 'Group II (low-dose cilengitide) 500mg', 'description': 'Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (500mg)\n\nResection: All patients undergo tumor resection on day 0.\n\nPostoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity', 'interventionNames': ['Drug: cilengitide', 'Procedure: therapeutic conventional surgery', 'Other: pharmacological study', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'cilengitide', 'type': 'DRUG', 'otherNames': ['EMD 121974'], 'description': 'Given IV', 'armGroupLabels': ['Group I (high-dose cilengitide) 2000mg', 'Group II (low-dose cilengitide) 500mg']}, {'name': 'therapeutic conventional surgery', 'type': 'PROCEDURE', 'description': 'Undergo tumor resection', 'armGroupLabels': ['Group I (high-dose cilengitide) 2000mg', 'Group II (low-dose cilengitide) 500mg']}, {'name': 'pharmacological study', 'type': 'OTHER', 'otherNames': ['pharmacological studies'], 'description': 'Correlative studies', 'armGroupLabels': ['Group I (high-dose cilengitide) 2000mg', 'Group II (low-dose cilengitide) 500mg']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Group I (high-dose cilengitide) 2000mg', 'Group II (low-dose cilengitide) 500mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02472', 'city': 'Watertown', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'North American Brain Tumor Consortium', 'geoPoint': {'lat': 42.37093, 'lon': -71.18283}}], 'overallOfficials': [{'name': 'Mark Gilbert', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North American Brain Tumor Consortium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}