Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT00018967
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2001-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands', 'New Zealand', 'Puerto Rico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D020258', 'term': 'Neurotoxicity Syndromes'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629556', 'term': 'glucarpidase'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1993-11'}, 'statusVerifiedDate': '2007-04', 'lastUpdateSubmitDate': '2015-04-29', 'studyFirstSubmitDate': '2001-07-11', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['unspecified childhood solid tumor, protocol specific', 'unspecified adult solid tumor, protocol specific', 'neurotoxicity'], 'conditions': ['Neurotoxicity', 'Unspecified Adult Solid Tumor, Protocol Specific', 'Unspecified Childhood Solid Tumor, Protocol Specific']}, 'referencesModule': {'references': [{'pmid': '15494606', 'type': 'RESULT', 'citation': "Widemann BC, Balis FM, Shalabi A, Boron M, O'Brien M, Cole DE, Jayaprakash N, Ivy P, Castle V, Muraszko K, Moertel CL, Trueworthy R, Hermann RC, Moussa A, Hinton S, Reaman G, Poplack D, Adamson PC. Treatment of accidental intrathecal methotrexate overdose with intrathecal carboxypeptidase G2. J Natl Cancer Inst. 2004 Oct 20;96(20):1557-9. doi: 10.1093/jnci/djh270."}, {'type': 'RESULT', 'citation': 'Widemann BC, Balis FM, Shalabi A, et al.: Carboxypeptidase-G2 (CPDG2) treatment of accidental intrathecal (IT) methotrexate (MTX) overdose. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-490, 2002.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Chemoprotective drugs such as carboxypeptidase-G2 may protect normal cells from the toxic effects of chemotherapy.\n\nPURPOSE: Clinical trial to study the effectiveness of carboxypeptidase-G2 in treating nervous system toxic effects in patients given an accidental overdose of intrathecal methotrexate.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the effectiveness of carboxypeptidase-G2 rescue in patients who develop life threatening methotrexate (MTX) neurotoxicity following accidental intrathecal MTX overdose.\n* Study the CSF pharmacokinetics of MTX following rescue.\n\nOUTLINE: Patients undergo a lumbar puncture as soon as possible after methotrexate overdose to remove methotrexate and receive a single dose of carboxypeptidase-G2 intrathecally over 5 minutes.\n\nPatients are followed for at least 1 month.\n\nPROJECTED ACCRUAL: A maximum of 10 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Patients who received an intrathecal overdose of methotrexate of 100 mg or more\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Any age\n\nPerformance status:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nOther:\n\n* No prior anaphylactic reaction to carboxypeptidase-G2 administration\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* See Disease Characteristics\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified\n\nOther\n\n* Concurrent therapy allowed'}, 'identificationModule': {'nctId': 'NCT00018967', 'briefTitle': 'Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate', 'nctIdAliases': ['NCT00001299'], 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Trial of Carboxypeptidase-G2 (CPDG2) For The Management of Patients With Intrathecal Methotrexate Overdose', 'orgStudyIdInfo': {'id': 'CDR0000077521'}, 'secondaryIdInfos': [{'id': 'NCI-92-C-0137N'}, {'id': 'CCG-0923'}, {'id': 'POG-9688'}, {'id': 'NCI-T92-0021N'}, {'id': 'COG-0923'}, {'id': 'COG-P9688'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'glucarpidase', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama Mitchell Cancer Institute', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Cancer Research Center at University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90242-2814', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Permanente Medical Group', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Cancer Institute at Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '93638-8762', 'city': 'Madera', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Central California", 'geoPoint': {'lat': 36.96134, 'lon': -120.06072}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center - 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