Nctid:
NCT00002738
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008223", "term"=>"Lymphoma"}, {"id"=>"D007938", "term"=>"Leukemia"}, {"id"=>"D054198", "term"=>"Precursor Cell Lymphoblastic Leukemia-Lymphoma"}, {"id"=>"D007945", "term"=>"Leukemia, Lymphoid"}], "ancestors"=>[{"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D008232", "term"=>"Lymphoproliferative Disorders"}, {"id"=>"D008206", "term"=>"Lymphatic Diseases"}, {"id"=>"D007160", "term"=>"Immunoproliferative Disorders"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}, {"id"=>"D006402", "term"=>"Hematologic Diseases"}], "browseLeaves"=>[{"id"=>"M14850", "name"=>"Recurrence", "relevance"=>"LOW"}, {"id"=>"M15327", "name"=>"Sarcoma", "relevance"=>"LOW"}, {"id"=>"M11220", "name"=>"Lymphoma", "asFound"=>"Lymphoma", "relevance"=>"HIGH"}, {"id"=>"M10945", "name"=>"Leukemia", "asFound"=>"Leukemia", "relevance"=>"HIGH"}, {"id"=>"M27585", "name"=>"Precursor Cell Lymphoblastic Leukemia-Lymphoma", "asFound"=>"Acute Lymphoblastic Leukemia", "relevance"=>"HIGH"}, {"id"=>"M10951", "name"=>"Leukemia, Lymphoid", "asFound"=>"Lymphoblastic Leukemia", "relevance"=>"HIGH"}, {"id"=>"M15334", "name"=>"Osteosarcoma", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M11225", "name"=>"Lymphoproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"M11203", "name"=>"Lymphatic Diseases", "relevance"=>"LOW"}, {"id"=>"M10206", "name"=>"Immunoproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M9490", "name"=>"Hematologic Diseases", "relevance"=>"LOW"}, {"id"=>"T5284", "name"=>"Soft Tissue Sarcoma", "relevance"=>"LOW"}, {"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}, {"id"=>"T3543", "name"=>"Lymphosarcoma", "asFound"=>"Lymphoma", "relevance"=>"HIGH"}, {"id"=>"T175", "name"=>"Acute Lymphoblastic Leukemia", "asFound"=>"Acute Lymphoblastic Leukemia", "relevance"=>"HIGH"}, {"id"=>"T3533", "name"=>"Lymphoblastic Lymphoma", "asFound"=>"Acute Lymphoblastic Leukemia", "relevance"=>"HIGH"}, {"id"=>"T4340", "name"=>"Osteosarcoma", "relevance"=>"LOW"}, {"id"=>"T1134", "name"=>"Childhood Acute Lymphoblastic Leukemia", "asFound"=>"Childhood acute lymphoblastic leukemia", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D002955", "term"=>"Leucovorin"}, {"id"=>"D016597", "term"=>"Trimetrexate"}, {"id"=>"D002118", "term"=>"Calcium"}, {"id"=>"D058766", "term"=>"Levoleucovorin"}], "ancestors"=>[{"id"=>"D000077264", "term"=>"Calcium-Regulating Hormones and Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000931", "term"=>"Antidotes"}, {"id"=>"D020011", "term"=>"Protective Agents"}, {"id"=>"D014803", "term"=>"Vitamin B Complex"}, {"id"=>"D014815", "term"=>"Vitamins"}, {"id"=>"D018977", "term"=>"Micronutrients"}, {"id"=>"D000935", "term"=>"Antifungal Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000964", "term"=>"Antimetabolites, Antineoplastic"}, {"id"=>"D000963", "term"=>"Antimetabolites"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D005493", "term"=>"Folic Acid Antagonists"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}], "browseLeaves"=>[{"id"=>"M6191", "name"=>"Leucovorin", "asFound"=>"May", "relevance"=>"HIGH"}, {"id"=>"M5381", "name"=>"Calcium", "asFound"=>"Protocol", "relevance"=>"HIGH"}, {"id"=>"M29233", "name"=>"Levoleucovorin", "asFound"=>"Dynamic", "relevance"=>"HIGH"}, {"id"=>"M5398", "name"=>"Calcium, Dietary", "relevance"=>"LOW"}, {"id"=>"M18981", "name"=>"Trimetrexate", "asFound"=>"Quinidine", "relevance"=>"HIGH"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M4250", "name"=>"Antidotes", "relevance"=>"LOW"}, {"id"=>"M21869", "name"=>"Protective Agents", "relevance"=>"LOW"}, {"id"=>"M17558", "name"=>"Vitamins", "relevance"=>"LOW"}, {"id"=>"M17546", "name"=>"Vitamin B Complex", "relevance"=>"LOW"}, {"id"=>"M8618", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"M21009", "name"=>"Micronutrients", "relevance"=>"LOW"}, {"id"=>"M16885", "name"=>"Trace Elements", "relevance"=>"LOW"}, {"id"=>"M4254", "name"=>"Antifungal Agents", "relevance"=>"LOW"}, {"id"=>"M6252", "name"=>"Clotrimazole", "relevance"=>"LOW"}, {"id"=>"M11796", "name"=>"Miconazole", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M8619", "name"=>"Folic Acid Antagonists", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"T447", "name"=>"Folinic Acid", "asFound"=>"Dynamic", "relevance"=>"HIGH"}, {"id"=>"T446", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"T448", "name"=>"Folate", "relevance"=>"LOW"}, {"id"=>"T475", "name"=>"Vitamin B9", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Bone Density Conservation Agents", "abbrev"=>"BDCA"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>25}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1996-01"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2013-03", "completionDateStruct"=>{"date"=>"2006-06", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2013-03-06", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2003-01-26", "lastUpdatePostDateStruct"=>{"date"=>"2013-03-07", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2003-01-27", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2006-06", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["recurrent childhood acute lymphoblastic leukemia", "recurrent childhood lymphoblastic lymphoma", "recurrent osteosarcoma", "recurrent childhood small noncleaved cell lymphoma", "recurrent childhood large cell lymphoma"], "conditions"=>["Leukemia", "Lymphoma", "Sarcoma"]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Drugs used in chemotherapy, such as trimetrexate glucuronate and leucovorin, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.\n\nPURPOSE: This phase II trial is studying how well combination chemotherapy works in treating children with recurrent acute lymphoblastic leukemia, recurrent osteosarcoma, or refractory non-Hodgkin's lymphoma.", "detailedDescription"=>"OBJECTIVES:\n\n* Determine the efficacy of trimetrexate glucuronate with leucovorin calcium rescue in children with recurrent acute lymphoblastic leukemia, recurrent osteogenic sarcoma, or refractory non-Hodgkin's lymphoma resistant to methotrexate.\n* Evaluate the toxicity of this treatment regimen in this patient population.\n\nOUTLINE: Patients are stratified according to disease (acute lymphocytic leukemia, non-Hodgkin's lymphoma vs osteogenic sarcoma).\n\nPatients receive trimetrexate glucuronate orally or IV every 12 hours on days 1-21 and oral leucovorin calcium every 12 hours on days 1-24. Treatment repeats every 4 weeks. Patients with stable or responsive disease may receive up to 4 courses of therapy.\n\nPROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"21 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\n* Histologic evidence of one of the following malignancies that has failed conventional therapy:\n\n * Acute lymphoblastic leukemia\n * Non-Hodgkin's lymphoma with bone marrow involvement\n * Osteogenic sarcoma\n* In vitro transport resistance to methotrexate demonstrated by bone marrow aspirate assay\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 21 and under at diagnosis\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* At least 8 weeks\n\nHematopoietic:\n\n* Granulocytopenia allowed with bone marrow involvement\n* Thrombocytopenia allowed with bone marrow involvement\n* Anemia allowed with bone marrow involvement\n\nHepatic:\n\n* (unless due to disease)\n* Bilirubin no greater than 2.0 mg/dL\n* AST no greater than 100\n\nRenal:\n\n* Creatinine less than 1.5 mg/dL OR\n* Creatinine clearance at least 60 mL/min\n\nOther:\n\n* No other serious medical illness\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Prior bone marrow transplantation allowed\n\nChemotherapy:\n\n* At least 1 week since prior intrathecal treatment\n* At least 2 weeks since prior systemic chemotherapy and recovered\n\n * At least 10 days for rapidly proliferating leukemia (i.e., WBC greater than 50,000)\n* No concurrent chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* Prior radiotherapy allowed and recovered\n* No concurrent radiotherapy\n\nSurgery:\n\n* Not specified"}, "identificationModule"=>{"nctId"=>"NCT00002738", "briefTitle"=>"Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia, Osteosarcoma, or Non-Hodgkin's Lymphoma", "organization"=>{"class"=>"OTHER", "fullName"=>"Memorial Sloan Kettering Cancer Center"}, "officialTitle"=>"Phase II Trial of Trimetrexate and Leucovorin in The Treatment of Recurrent Childhood Acute Lymphoblastic Leukemia", "orgStudyIdInfo"=>{"id"=>"95-093"}, "secondaryIdInfos"=>[{"id"=>"P30CA008748", "link"=>"https://reporter.nih.gov/quickSearch/P30CA008748", "type"=>"NIH"}, {"id"=>"MSKCC-95093"}, {"id"=>"NCI-V96-0840"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"leucovorin calcium", "type"=>"DRUG"}, {"name"=>"trimetrexate glucuronate", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"10021", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Memorial Sloan-Kettering Cancer Center", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}], "overallOfficials"=>[{"name"=>"Tanya Trippett, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"Memorial Sloan Kettering Cancer Center"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Memorial Sloan Kettering Cancer Center", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}]}}}
