Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-27 @ 3:01 PM
Study NCT ID:
NCT00003466
Status:
COMPLETED
Last Update Posted:
2014-07-09
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Temozolomide in Treating Patients With Progressive 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': 'D018315', 'term': 'Glioma, Subependymal'}, {'id': 'D020339', 'term': 'Optic Nerve Glioma'}, {'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'}, {'id': 'D004806', 'term': 'Ependymoma'}, {'id': 'D019574', 'term': 'Optic Nerve Neoplasms'}, {'id': 'D003390', 'term': 'Cranial Nerve Neoplasms'}, {'id': 'D010524', 'term': 'Peripheral Nervous System Neoplasms'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-07', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2014-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate'}, {'measure': 'Activity of temozolomide'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['recurrent adult brain tumor', 'adult mixed glioma', 'childhood mixed glioma', 'adult pilocytic astrocytoma', 'adult subependymoma', 'recurrent childhood cerebral astrocytoma', 'adult brain stem glioma', 'recurrent childhood brain stem glioma', 'untreated childhood brain stem glioma', 'recurrent childhood visual pathway and hypothalamic glioma', 'untreated childhood visual pathway and hypothalamic glioma', 'adult oligodendroglioma', 'adult diffuse astrocytoma'], '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: This phase II trial is studying how well temozolomide works in treating patients with progressive low-grade glioma.', 'detailedDescription': 'OBJECTIVES:\n\n* Assess the response rate in patients with progressive low-grade gliomas treated with temozolomide.\n* Determine the activity of this drug, in terms of stabilizing growth of progressive low-grade gliomas, in adult patients.\n\nOUTLINE: Patients are stratified by disease type (pilocytic astrocytoma, mixed glioma, well-differentiated oligodendroglioma, and nonbiopsied optic pathway glioma or pontine glioma).\n\nPatients receive temozolomide orally once daily on days 1-5. Courses repeat every 28 days. In the absence of disease progression or unacceptable toxicity, patients may continue with treatment until tumor has remained stable for 12 courses.\n\nPatients are followed every 8-12 weeks for 2 years.\n\nPROJECTED ACCRUAL: A total of 36-100 patients (9-25 per stratum) will be accrued for this study within 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed progressive, primary, intracranial, supratentorial, low-grade glioma including:\n\n * Astrocytoma\n * Oligodendroglioma\n * Mixed glioma\n * Optic pathway glioma\\*\n * Pontine glioma\\* NOTE: \\*Biopsy not required\n* Patients with optic pathway glioma must also meet the following criteria:\n\n * Progressive loss of vision as defined by doubling of octaves\n * Visual acuity loss not explained by other causes\n * Increase in proptosis of greater than 3 mm\n * Increase in diameter of optic nerve of at least 2 mm on neuroimaging\n * Increase in distribution of tumor involving optic tracts or optic radiations as indicated by CT scan or MRI\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 4 and over\n\nPerformance status:\n\n* Karnofsky 70-100%\n\nLife expectancy:\n\n* More than 12 weeks\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 10 g/dL\n\nHepatic:\n\n* Bilirubin less than 1.5 times upper limit of normal (ULN)\n* SGOT and SGPT less than 2.5 times ULN\n* Alkaline phosphatase less than 2 times ULN\n\nRenal:\n\n* Creatinine less than 1.5 times ULN\n* BUN less than 1.5 times ULN\n\nOther:\n\n* Must be neurologically stable\n* No systemic disease\n* No acute infection requiring IV antibiotics\n* No frequent vomiting\n* No other medical condition that would interfere with oral medication (e.g., partial bowel obstruction)\n* No other prior or concurrent malignancies except:\n\n * Surgically cured carcinoma in situ of the cervix\n * Basal or squamous cell skin cancer\n* HIV negative\n* No AIDS-related illness\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No concurrent biologic therapy (growth factors or epoetin alfa)\n\nChemotherapy:\n\n* At least 6 weeks since prior chemotherapy unless evidence of disease progression\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* At least 6 weeks since prior radiotherapy unless evidence of disease progression\n* No concurrent radiotherapy\n\nSurgery:\n\n* At least 3 weeks since prior surgery unless evidence of disease progression\n* Recovered from all prior surgery\n\nOther:\n\n* No other concurrent investigational drugs'}, 'identificationModule': {'nctId': 'NCT00003466', 'briefTitle': 'Temozolomide in Treating Patients With Progressive Low-Grade Glioma', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal', 'orgStudyIdInfo': {'id': '1703 (CDR0000066502)'}, 'secondaryIdInfos': [{'id': 'DUMC-1703-04-12R7'}, {'id': 'DUMC-000693-01-3R1'}, {'id': 'DUMC-1703-01-94R'}, {'id': 'DUMC-1502-97-10'}, {'id': 'DUMC-1569-98-10R1'}, {'id': 'DUMC-97125'}, {'id': 'NCI-G98-1469'}, {'id': 'DUMC-1703-02-9R5'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'temozolomide', '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}}, {'zip': '19104-4318', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Henry S. Friedman, 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'}}}}