Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-28 @ 1:53 AM
Study NCT ID:
NCT00003467
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D009837', 'term': 'Oligodendroglioma'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'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': 'D002330', 'term': 'Carmustine'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}], 'ancestors': [{'id': 'D009607', 'term': 'Nitrosourea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009603', 'term': 'Nitroso Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2004-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-19', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['recurrent adult brain tumor', 'adult brain stem glioma', 'adult mixed glioma', 'adult anaplastic astrocytoma', 'adult pilocytic astrocytoma', 'adult oligodendroglioma'], 'conditions': ['Brain and Central Nervous System Tumors']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: Phase II trial to study the effectiveness of carmustine in treating adults with recurrent supratentorial low-grade glioma.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the antitumor activity of Gliadel wafers (carmustine) in the treatment of recurrent supratentorial low grade glioma.\n* Assess the toxicity of this therapy in these patients.\n\nOUTLINE: Patients are stratified by disease (fibrillary astrocytoma vs oligodendroglioma or mixed glioma).\n\nPatients receive up to 8 Gliadel wafers (containing carmustine) implanted in the resected tumor cavity.\n\nPatients are followed every 2 months.\n\nPROJECTED ACCRUAL: This study will accrue a maximum of 68 patients within 18-24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed recurrent primary low grade glioma including:\n\n * Fibrillary astrocytoma\n * Oligodendroglioma\n * Mixed glioma\n* Evidence of measurable enhancing or non-enhancing CNS neoplasm on MRI\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Karnofsky 60-100%\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Hematocrit greater than 29%\n* Absolute neutrophil count greater than 1500/mm\\^3\n* Platelet count greater than 125,000/mm\\^3\n\nHepatic:\n\n* SGOT less than 1.5 times upper limit of normal (ULN)\n* Bilirubin less than 1.5 times ULN\n\nRenal:\n\n* Creatinine less than 1.5 mg/dL\n* BUN less than 25 mg/dL\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* At least 4 weeks since prior chemotherapy unless disease progression\n\nEndocrine therapy:\n\n* Concurrent corticosteroids allowed (must be on stable dose for 1 week prior to study)\n* No concurrent immunosuppressive agents\n\nRadiotherapy:\n\n* At least 4 weeks since prior radiotherapy unless disease progression\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* No other concurrent medication that may interfere with study'}, 'identificationModule': {'nctId': 'NCT00003467', 'briefTitle': 'Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Phase II Treatment of Adults With Recurrent Supratentorial Low Grade Glioma With Gliadel Wafers', 'orgStudyIdInfo': {'id': '1706'}, 'secondaryIdInfos': [{'id': 'DUMC-1706-02-9R5'}, {'id': 'DUMC-1706-01-9R4'}, {'id': 'DUMC-000693-00-4'}, {'id': 'DUMC-1509-97-10'}, {'id': 'DUMC-1568-98-10R1'}, {'id': 'DUMC-1706-00-9R3'}, {'id': 'DUMC-97131'}, {'id': 'NCI-G98-1470'}, {'id': 'CDR0000066503', 'type': 'OTHER', 'domain': 'NCI'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'carmustine', 'type': 'DRUG'}, {'name': 'polifeprosan 20 with carmustine implant', 'type': 'DRUG'}, {'name': 'surgical procedure', 'type': 'PROCEDURE'}]}, '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': 'Henry S. Friedman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Henry Friedman, MD', 'oldOrganization': 'Duke UMC'}}}}