Nctid:
NCT00001298
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-21"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000007674", "term"=>"Kidney Diseases"}, {"id"=>"D000051437", "term"=>"Renal Insufficiency"}], "ancestors"=>[{"id"=>"D000014570", "term"=>"Urologic Diseases"}, {"id"=>"D000052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D000005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000052801", "term"=>"Male Urogenital Diseases"}], "browseLeaves"=>[{"id"=>"M26718", "name"=>"Renal Insufficiency", "asFound"=>"Renal Dysfunction", "relevance"=>"HIGH"}, {"id"=>"M10698", "name"=>"Kidney Diseases", "asFound"=>"Kidney Disease", "relevance"=>"HIGH"}, {"id"=>"M17319", "name"=>"Urologic Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4225", "name"=>"Antibodies", "relevance"=>"LOW"}, {"id"=>"M10184", "name"=>"Immunoglobulins", "relevance"=>"LOW"}, {"id"=>"M11703", "name"=>"Methotrexate", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"Dermatologic Agents", "abbrev"=>"Derm"}, {"name"=>"Reproductive Control Agents", "abbrev"=>"Repr"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>10}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1992-03"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2000-02", "completionDateStruct"=>{"date"=>"2001-01"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"2002-12-09", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2002-12-10", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Antibody", "DAMPA", "Enzyme", "Kidney", "Pharmacokinetics", "Thymidine", "Toxicity"], "conditions"=>["Kidney Diseases"]}, "referencesModule"=>{"references"=>[{"pmid"=>"1634927", "type"=>"BACKGROUND", "citation"=>"Adamson PC, Balis FM, McCully CL, Godwin KS, Poplack DG. Methotrexate pharmacokinetics following administration of recombinant carboxypeptidase-G2 in rhesus monkeys. J Clin Oncol. 1992 Aug;10(8):1359-64. doi: 10.1200/JCO.1992.10.8.1359."}, {"pmid"=>"8625136", "type"=>"BACKGROUND", "citation"=>"Widemann BC, Hetherington ML, Murphy RF, Balis FM, Adamson PC. Carboxypeptidase-G2 rescue in a patient with high dose methotrexate-induced nephrotoxicity. Cancer. 1995 Aug 1;76(3):521-6. doi: 10.1002/1097-0142(19950801)76:33.0.co;2-m."}, {"pmid"=>"9164227", "type"=>"BACKGROUND", "citation"=>"Widemann BC, Balis FM, Murphy RF, Sorensen JM, Montello MJ, O'Brien M, Adamson PC. Carboxypeptidase-G2, thymidine, and leucovorin rescue in cancer patients with methotrexate-induced renal dysfunction. J Clin Oncol. 1997 May;15(5):2125-34. doi: 10.1200/JCO.1997.15.5.2125."}]}, "descriptionModule"=>{"briefSummary"=>"High dose methotrexate with leucovorin rescue has demonstrated activity in numerous malignancies. Although high dose methotrexate is generally well tolerated, unpredictable life-threatening toxicity can occur. For patients who have markedly delayed clearance of methotrexate secondary to renal dysfunction, therapeutic options are few and are of limited efficacy. Carboxypeptidase-G2 inactivates methotrexate by hydrolyzing its C-terminal glutamate residue. Carboxypeptidase-G2 could be used to rescue patients with renal dysfunction and delayed methotrexate excretion, as it provides an alternative to renal clearance as a route of elimination.", "detailedDescription"=>"High dose methotrexate with leucovorin rescue has demonstrated activity in numerous malignancies. Although high dose methotrexate is generally well tolerated, unpredictable life-threatening toxicity can occur. For patients who have markedly delayed clearance of methotrexate secondary to renal dysfunction, therapeutic options are few and are of limited efficacy. Carboxypeptidase-G2 inactivates methotrexate by hydrolyzing its C-terminal glutamate residue. Carboxypeptidase-G2 could be used to rescue patients with renal dysfunction and delayed methotrexate excretion, as it provides an alternative to renal clearance as a route of elimination."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"Patients of any age at risk for life-threatening toxicity following MTX administration secondary to delayed drug excretion as defined by:\n\nPlasma MTX concentration at least 10 micromoles/liter more than 42 hours after the start of the MTX infusion; OR\n\nCreatinine at least 1.5 times the upper limit of normal or creatinine clearance less than 60 ml/sqm/min and delayed MTX excretion documented by plasma MTX concentration measurements (at least 2 standard deviations above the mean) at least 12 hours following MTX administration."}, "identificationModule"=>{"nctId"=>"NCT00001298", "briefTitle"=>"A Trial of Carboxypeptidase-G2 (CPDG2) and Thymidine for the Management of Patients With Methotrexate Toxicity and Renal Dysfunction", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"A Trial of Carboxypeptidase-G2 (CPDG2) and Thymidine for the Management of Patients With Methotrexate Toxicity and Renal Dysfunction", "orgStudyIdInfo"=>{"id"=>"920134"}, "secondaryIdInfos"=>[{"id"=>"92-C-0134"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"carboxypeptidase-G2", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Cancer Institute (NCI)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}}}}
