Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT00921167
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
2009-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Gliomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D001254', 'term': 'Astrocytoma'}], 'ancestors': [{'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'}]}, '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': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-03', 'studyFirstSubmitDate': '2009-06-13', 'studyFirstSubmitQcDate': '2009-06-13', 'lastUpdatePostDateStruct': {'date': '2013-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '6 months, 1 year'}], 'secondaryOutcomes': [{'measure': 'Objective response rate', 'timeFrame': '6 weeks, 12 weeks'}, {'measure': 'Overall survival', 'timeFrame': '6 months, 1 year'}, {'measure': 'Disease-control rate', 'timeFrame': '6 weeks, 12 weeks'}, {'measure': 'Adverse event', 'timeFrame': '3 weeks, 6 weeks, 9 weeks, 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glioblastoma', 'Astrocytoma', 'Chemotherapy'], 'conditions': ['Glioblastoma', 'Astrocytoma']}, 'descriptionModule': {'briefSummary': 'To assess the efficacy and safety of bevacizumab plus irinotecan for the patients with recurrent anaplastic astrocytoma or with recurrent glioblastoma multiforme'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically diagnosed recurrent anaplastic astrocytoma or recurrent glioblastoma multiforme\n* At least 18 years of age\n* Performance status of 0 and 1 on the Eastern Cooperative Oncology Group (ECOG) criteria\n* One or more measurable disease\n* Adequate hematologic (neutrophil count \\>= 1500/uL, platelets \\>= 100,000/uL), hepatic (transaminase =\\< upper normal limit (UNL)x2.5, bilirubin level =\\< UNLx1.5, alkaline phosphatase =\\< UNLx2.5), and renal (creatinine clearance \\>= 30mL/min)\n* Expected life time more than at least 2 months\n* A patients who signed the informed consent prior to the participation in the study\n\nExclusion Criteria:\n\n* A pregnant or lactating patient\n* A patient of childbearing potential without being tested for pregnancy at baseline or with a positive test. (A premenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)\n* A man or woman of childbearing potential without the willingness to use a contraceptive measures during the study\n* A patient with history of another malignant disease within past 3 years, except curatively treated basal cell carcinoma of the skin, cervical carcinoma in situ, and early gastric cancer\n* Medically uncontrolled serious heart, lung, neurological, psychological, or metabolic disease\n* Uncontrolled serious infection\n* Enrollment in other study within 30 days\n* Hemorrhage on baseline radiologic examination\n* A patient who refused to sign the informed consent'}, 'identificationModule': {'nctId': 'NCT00921167', 'briefTitle': 'A Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Gliomas', 'organization': {'class': 'OTHER', 'fullName': 'Clinical Research Center for Solid Tumor, Korea'}, 'officialTitle': 'A Phase II Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Anaplastic Astrocytoma or Recurrent Glioblastoma Multiforme', 'orgStudyIdInfo': {'id': 'CRCST-L-0006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bevacizumab/Irinotecan', 'interventionNames': ['Drug: Bevacizumab/Irinotecan']}], 'interventions': [{'name': 'Bevacizumab/Irinotecan', 'type': 'DRUG', 'description': 'Bevacizumab 10mg/kg D1 Irinotecan 125mg/m2 D1 (without enzyme-inducing antiepileptic drugs \\[EIAEDs\\] or 340mg/m2 for patients on EIAEDs) every 2 weeks', 'armGroupLabels': ['Bevacizumab/Irinotecan']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinical Research Center for Solid Tumor, Korea', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seoul National University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}