Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT00036660
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2002-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SarCNU in Treating Patients With Recurrent Malignant 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': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D018316', 'term': 'Gliosarcoma'}], '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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C044565', 'term': '2-((((2-chloroethyl)nitrosoamino)carbonyl)amino)propanamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2008-09-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-02', 'studyFirstSubmitDate': '2002-05-13', 'studyFirstSubmitQcDate': '2003-07-07', 'lastUpdatePostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-04-15', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['recurrent adult brain tumor', 'adult glioblastoma', 'adult anaplastic astrocytoma', 'adult giant cell glioblastoma', 'adult gliosarcoma'], 'conditions': ['Brain and Central Nervous System Tumors']}, 'referencesModule': {'references': [{'pmid': '16034522', 'type': 'RESULT', 'citation': 'Webster M, Cairncross G, Gertler S, Perry J, Wainman N, Eisenhauer E. Phase II trial of SarCNU in malignant glioma: unexpected pulmonary toxicity with a novel nitrosourea: a phase II trial of the national cancer institute of canada clinical trials group. Invest New Drugs. 2005 Dec;23(6):591-6. doi: 10.1007/s10637-005-1761-3.'}]}, '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 sarCNU in treating patients who have recurrent malignant glioma.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the efficacy of SarCNU, in terms of objective response and duration of response, in patients with recurrent malignant gliomas.\n* Determine the qualitative and quantitative toxic effects of this drug in these patients.\n* Determine the time to progression and survival of patients treated with this drug.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive oral SarCNU on days 1, 5, and 9. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed at 4 weeks and then every 3 months thereafter.\n\nPROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed malignant glioma\n\n * Anaplastic astrocytoma (AA) OR\n * Glioblastoma multiforme (GBM)\n* Recurrent or progressive disease by contrast-enhanced CT scan or MRI after primary surgery and radiotherapy\n* At least 1 bidimensionally measurable lesion\n\n * At least 1 cm by 1 cm on contrast-enhanced CT scan or MRI\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* At least 12 weeks\n\nHematopoietic:\n\n* Absolute granulocyte count at least 1,500/mm3\n* Platelet count at least 120,000/mm3\n\nHepatic:\n\n* Bilirubin normal\n* AST and ALT no greater than 2.5 times upper limit of normal\n\nRenal:\n\n* Creatinine normal OR\n* Creatinine clearance at least 60 mL/min\n\nCardiovascular:\n\n* No symptomatic congestive heart failure\n* No unstable angina pectoris\n* No cardiac arrhythmia\n\nPulmonary:\n\n* DLCO at least 70% of predicted\n* FVC at least 70% of predicted\n\nOther:\n\n* No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix\n* No ongoing or active uncontrolled infection\n* No other serious illness or medical condition that would preclude study\n* No history of significant neurologic or psychiatric disorder that would preclude study\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for at least 3 months after study\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 6 weeks since prior immunotherapy\n* No concurrent immunotherapy\n\nChemotherapy:\n\n* At least 6 weeks since prior chemotherapy\n* No more than 1 prior adjuvant chemotherapy regimen for AA\n* No prior chemotherapy for recurrent disease\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* Patients must be on a stable dose of steroids for at least 2 weeks prior to study\n\nRadiotherapy:\n\n* See Disease Characteristics\n* At least 4 weeks since prior radiotherapy\n* No prior radiotherapy for recurrent disease\n* No concurrent radiotherapy\n\nSurgery:\n\n* See Disease Characteristics\n* Prior surgery for recurrent disease (e.g., stereotactic biopsy or partial resection) allowed\n* At least 4 weeks since prior surgery (except for biopsy)\n\nOther:\n\n* At least 6 weeks since prior investigational agents\n* No other concurrent investigational agents\n* No other concurrent anticancer treatment'}, 'identificationModule': {'nctId': 'NCT00036660', 'briefTitle': 'SarCNU in Treating Patients With Recurrent Malignant Glioma', 'organization': {'class': 'NETWORK', 'fullName': 'Canadian Cancer Trials Group'}, 'officialTitle': 'A Phase II Study of SarCNU (NSC 364432) in Patients With Malignant Glioma', 'orgStudyIdInfo': {'id': 'I142'}, 'secondaryIdInfos': [{'id': 'CAN-NCIC-IND142', 'type': 'OTHER', 'domain': 'PDQ'}, {'id': 'CDR0000068652', 'type': 'OTHER', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'SarCNU', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Center - Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'K1H 1C4', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Regional Cancer Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Sunnybrook Regional Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2W 1S6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Lawrence C. Panasci, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Jewish General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NCIC Clinical Trials Group', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}