Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT00283556
Status:
COMPLETED
Last Update Posted:
2010-01-20
First Post:
2006-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Dose Camptothecin-11 (CPT-11) in Recurrent Unresectable Malignant Glioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'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': 'D000077146', 'term': 'Irinotecan'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-18', 'studyFirstSubmitDate': '2006-01-26', 'studyFirstSubmitQcDate': '2006-01-26', 'lastUpdatePostDateStruct': {'date': '2010-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The purpose of this study is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.', 'timeFrame': '2008'}]}, 'conditionsModule': {'keywords': ['High Dose Irinotecan', 'CPT-11', 'Camptosar', 'Malignant Glioma', 'Unresectable'], 'conditions': ['Malignant Glioma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.', 'detailedDescription': 'This is a phase I/II study of high dose irinotecan in patients with recurrent unresectable malignant glioma on steroids/anti-epileptics. The purpose is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* recurrent, unresectable primary CNS neoplasm per MRI\n* ECOG status of 2 or less\n* no prior therapy with camptothecans\n* on an enzyme-inducing antiepileptic'}, 'identificationModule': {'nctId': 'NCT00283556', 'briefTitle': 'High Dose Camptothecin-11 (CPT-11) in Recurrent Unresectable Malignant Glioma', 'organization': {'class': 'OTHER', 'fullName': 'Kentuckiana Cancer Institute'}, 'officialTitle': 'Phase I/II Study of High Dose Irinotecan (Camptosar, CPT-11) in Patients With Recurrent Unresectable Malignant Glioma on Steroids/Anti-epileptics', 'orgStudyIdInfo': {'id': '1068114'}, 'secondaryIdInfos': [{'id': '44OE-ONC-0020-3'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort #1', 'description': 'Cohort #1--Irinotecan 750 mg/m2 IV over 90 minutes every (Q) 3 weeks x 15 patients.\n\nAdditional increments of 50 mg/m2 for subsequent cohorts until MTD is reached.', 'interventionNames': ['Drug: Irinotecan (Camptosar, CPT-11)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort #2', 'description': 'Cohort #2--Irinotecan 500 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients.\n\nAdditional increments of 50 mg/m2 for subsequent cohorts until MTD is reached.', 'interventionNames': ['Drug: Irinotecan (Camptosar, CPT-11)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort #3', 'description': 'Cohort #3--Irinotecan 600 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients.\n\nAdditional increments of 50 mg/m2 for subsequent cohorts until MTD is reached.', 'interventionNames': ['Drug: Irinotecan (Camptosar, CPT-11)']}], 'interventions': [{'name': 'Irinotecan (Camptosar, CPT-11)', 'type': 'DRUG', 'description': 'Cohort #1--Irinotecan 750 mg/m2 IV over 90 minutes Q 3 weeks x 15 patients; Cohort #2--Irinotecan 500 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients; Cohort #3--Irinotecan 600 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients.\n\nAdditional increments of 50 mg/m2 for subsequent cohorts until MTD is reached.', 'armGroupLabels': ['Cohort #1', 'Cohort #2', 'Cohort #3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentuckiana Cancer Institute', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Renato V. LaRocca, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kentuckiana Cancer Institute', 'class': 'OTHER'}}}}