Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-01-02 @ 1:18 PM
Study NCT ID:
NCT00268359
Status:
COMPLETED
Last Update Posted:
2014-07-21
First Post:
2005-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bevacizumab and Irinotecan in Treating Patients With Recurrent or Refractory Gliomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D009837', 'term': 'Oligodendroglioma'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D018316', 'term': 'Gliosarcoma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': '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': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-18', 'studyFirstSubmitDate': '2005-12-20', 'studyFirstSubmitQcDate': '2005-12-20', 'lastUpdatePostDateStruct': {'date': '2014-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety'}, {'measure': 'Activity in terms of progression-free survival'}]}, 'conditionsModule': {'keywords': ['adult anaplastic astrocytoma', 'adult anaplastic oligodendroglioma', 'adult glioblastoma', 'adult gliosarcoma', 'recurrent adult brain tumor', 'adult giant cell glioblastoma'], 'conditions': ['Brain and Central Nervous System Tumors']}, 'referencesModule': {'references': [{'pmid': '18981004', 'type': 'RESULT', 'citation': 'Desjardins A, Reardon DA, Herndon JE 2nd, Marcello J, Quinn JA, Rich JN, Sathornsumetee S, Gururangan S, Sampson J, Bailey L, Bigner DD, Friedman AH, Friedman HS, Vredenburgh JJ. Bevacizumab plus irinotecan in recurrent WHO grade 3 malignant gliomas. Clin Cancer Res. 2008 Nov 1;14(21):7068-73. doi: 10.1158/1078-0432.CCR-08-0260.'}, {'pmid': '18182667', 'type': 'RESULT', 'citation': 'Sathornsumetee S, Cao Y, Marcello JE, Herndon JE 2nd, McLendon RE, Desjardins A, Friedman HS, Dewhirst MW, Vredenburgh JJ, Rich JN. Tumor angiogenic and hypoxic profiles predict radiographic response and survival in malignant astrocytoma patients treated with bevacizumab and irinotecan. J Clin Oncol. 2008 Jan 10;26(2):271-8. doi: 10.1200/JCO.2007.13.3652.'}, {'pmid': '17317837', 'type': 'RESULT', 'citation': 'Vredenburgh JJ, Desjardins A, Herndon JE 2nd, Dowell JM, Reardon DA, Quinn JA, Rich JN, Sathornsumetee S, Gururangan S, Wagner M, Bigner DD, Friedman AH, Friedman HS. Phase II trial of bevacizumab and irinotecan in recurrent malignant glioma. Clin Cancer Res. 2007 Feb 15;13(4):1253-9. doi: 10.1158/1078-0432.CCR-06-2309.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with irinotecan may kill more tumors cells.\n\nPURPOSE: This phase II trial is studying the side effects of bevacizumab and how well giving bevacizumab together with irinotecan works in treating patients with recurrent or refractory gliomas.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the safety of bevacizumab and irinotecan hydrochloride in patients with recurrent or refractory grade 3 or 4 malignant gliomas.\n\nSecondary\n\n* Determine the activity of this regimen, in terms of progression-free survival, in these patients.\n\nOUTLINE: Patients receive bevacizumab and irinotecan hydrochloride every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nPROJECTED ACCRUAL: A total of 68 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed primary grade 3 or 4 malignant glioma of 1 of the following types:\n\n * Glioblastoma multiforme\n * Gliosarcoma\n * Anaplastic astrocytoma\n * Anaplastic oligodendroglioma\n* Patients with recurrent disease whose original diagnostic pathology confirmed malignant glioma will not need re-biopsy\n* Measurable recurrent or residual primary disease on contrast-enhanced MRI or CT scan\n* Failed ≥ 1 prior chemotherapy regimen (with or without radiotherapy)\n\nPATIENT CHARACTERISTICS:\n\n* Karnofsky performance status 60-100%\n* Hematocrit \\> 29%\n* Absolute neutrophil count \\> 1,500/mm\\^3\n* Platelets \\> 125,000/mm\\^3\n* Serum SGOT and bilirubin \\< 1.5 times upper limit of normal\n* Creatinine \\< 1.5 mg/dL\n* Urine protein:creatinine ratio ≤ 1.0\n* Blood pressure ≤ 150/100 mmHg\n* No unstable angina\n* No New York Heart Association class II or greater congestive heart failure\n* No myocardial infarction within the past 6 months\n* No stroke within the past 6 months\n* No clinically significant peripheral vascular disease\n* No evidence of bleeding diathesis or coagulopathy\n* No significant traumatic injury within the past 28 days\n\nPRIOR CONCURRENT THERAPY:\n\n* At least 4 weeks must have elapsed since prior chemotherapy or radiotherapy unless there is unequivocal evidence of tumor progression\n* At least 6 weeks since prior surgical resection\n* No previous major surgical procedures or open biopsies within 28 days prior to study entry\n* No previous minor surgical procedures, fine needle aspirations, or core biopsies within 7 days prior to study entry\n* No anticipated need for major surgical procedures during the course of the study\n* No concurrent aspirin, non-steroidal anti-inflammatory drugs, or clopidogrel'}, 'identificationModule': {'nctId': 'NCT00268359', 'briefTitle': 'Bevacizumab and Irinotecan in Treating Patients With Recurrent or Refractory Gliomas', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Bevacizumab in Combination With Irinotecan for Malignant Gliomas', 'orgStudyIdInfo': {'id': 'Pro00004091'}, 'secondaryIdInfos': [{'id': 'DUMC-6771-05-1R0'}, {'id': 'GENENTECH-AVF3311s'}, {'id': 'CDR0000450832', 'type': 'OTHER', 'domain': 'NCI'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'bevacizumab', 'type': 'BIOLOGICAL'}, {'name': 'irinotecan hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Comprehensive Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'James J. Vredenburgh, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Duke Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}