Nctid:
NCT00001333
Payload:
{"FullStudy"=>{"Rank"=>474316, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000008577", "ConditionMeshTerm"=>"Meningeal Neoplasms"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000016543", "ConditionAncestorTerm"=>"Central Nervous System Neoplasms"}, {"ConditionAncestorId"=>"D000009423", "ConditionAncestorTerm"=>"Nervous System Neoplasms"}, {"ConditionAncestorId"=>"D000009371", "ConditionAncestorTerm"=>"Neoplasms by Site"}, {"ConditionAncestorId"=>"D000009369", "ConditionAncestorTerm"=>"Neoplasms"}, {"ConditionAncestorId"=>"D000009422", "ConditionAncestorTerm"=>"Nervous System Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M10635", "ConditionBrowseLeafName"=>"Leukemia", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10910", "ConditionBrowseLeafName"=>"Lymphoma", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11250", "ConditionBrowseLeafName"=>"Meningeal Neoplasms", "ConditionBrowseLeafAsFound"=>"Meningeal Neoplasms", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M12057", "ConditionBrowseLeafName"=>"Nervous System Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18627", "ConditionBrowseLeafName"=>"Central Nervous System Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T3543", "ConditionBrowseLeafName"=>"Lymphosarcoma", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Blood and Lymph Conditions", "ConditionBrowseBranchAbbrev"=>"BC15"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}, {"ConditionBrowseBranchName"=>"Nervous System Diseases", "ConditionBrowseBranchAbbrev"=>"BC10"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000019772", "InterventionMeshTerm"=>"Topotecan"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000059004", "InterventionAncestorTerm"=>"Topoisomerase I Inhibitors"}, {"InterventionAncestorId"=>"D000059003", "InterventionAncestorTerm"=>"Topoisomerase Inhibitors"}, {"InterventionAncestorId"=>"D000004791", "InterventionAncestorTerm"=>"Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000000970", "InterventionAncestorTerm"=>"Antineoplastic Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M21364", "InterventionBrowseLeafName"=>"Topotecan", "InterventionBrowseLeafAsFound"=>"Stage II", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M29039", "InterventionBrowseLeafName"=>"Topoisomerase I Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7641", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"30"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"February 1993"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"January 2000", "CompletionDateStruct"=>{"CompletionDate"=>"December 2000"}, "LastUpdateSubmitDate"=>"March 3, 2008", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"December 9, 2002", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"March 4, 2008", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"December 10, 2002", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Intraventricular", "Meningeal Malignancy", "NSC 609699", "SKF 104864", "Topoisomerase 1"]}, "ConditionList"=>{"Condition"=>["Leukemia", "Lymphoma", "Meningeal Neoplasms"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"1312588", "ReferenceType"=>"background", "ReferenceCitation"=>"Rowinsky EK, Grochow LB, Hendricks CB, Ettinger DS, Forastiere AA, Hurowitz LA, McGuire WP, Sartorius SE, Lubejko BG, Kaufmann SH, et al. Phase I and pharmacologic study of topotecan: a novel topoisomerase I inhibitor. J Clin Oncol. 1992 Apr;10(4):647-56. doi: 10.1200/JCO.1992.10.4.647."}, {"ReferencePMID"=>"1933871", "ReferenceType"=>"background", "ReferenceCitation"=>"Adamson PC, Balis FM, Arndt CA, Holcenberg JS, Narang PK, Murphy RF, Gillespie AJ, Poplack DG. Intrathecal 6-mercaptopurine: preclinical pharmacology, phase I/II trial, and pharmacokinetic study. Cancer Res. 1991 Nov 15;51(22):6079-83."}, {"ReferencePMID"=>"8439950", "ReferenceType"=>"background", "ReferenceCitation"=>"Blaney SM, Balis FM, Cole DE, Craig C, Reid JM, Ames MM, Krailo M, Reaman G, Hammond D, Poplack DG. Pediatric phase I trial and pharmacokinetic study of topotecan administered as a 24-hour continuous infusion. Cancer Res. 1993 Mar 1;53(5):1032-6."}]}}, "DescriptionModule"=>{"BriefSummary"=>"The purpose of this study is to determine the qualitative and quantitative toxicity of intrathecal topotecan, a topoisomerase I inhibitor, in patients with meningeal malignancies refractory to conventional therapy (radiation therapy and chemotherapy).", "DetailedDescription"=>"The purpose of this study is to determine the qualitative and quantitative toxicity of intrathecal topotecan, a topoisomerase I inhibitor, in patients with meningeal malignancies refractory to conventional therapy (radiation therapy and chemotherapy). A safe dose of topotecan that can be recommended for intrathecal administration in subsequent phase II studies will be established in a limited dosage escalation schedule. The CSF pharmacokinetics of intrathecal topotecan will also be studied. Topotecan will be administered intrathecally on a bi-weekly basis for four to six weeks, followed by weekly administration for 1 month, twice monthly administration for four months and then monthly IT administration."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\nLeukemia, lymphoma, or solid tumor with overt meningeal involvement considered refractory to conventional therapy.\n\nCSF leukemic cell count at least 5 per cubic millimeter with evidence of blast cells on cytospin or cytology required for leukemia and lymphoma patients.\n\nTumor cells on cytospin or cytology or measurable meningeal disease on CT or MRI required for patients with solid tumors.\n\nNo clinical evidence of obstructive hydrocephalus or compartmentalization of the CSF flow as documented by indium-111- or technetium-99-DPTA flow study.\n\nPRIOR/CONCURRENT THERAPY:\n\nAt least 1 week since CNS therapy.\n\nBiologic Therapy: Recovery from toxic effects of prior immunotherapy required.\n\nChemotherapy:\n\nRecovery from toxic effects of prior chemotherapy required.\n\nNo concomitant therapy to treat meningeal malignancy (intrathecal or systemic).\n\nConcomitant chemotherapy to control systemic disease or bulk CNS disease allowed except: Investigational agents. Agents that penetrate the CNS (e.g., high-dose methotrexate, thiotepa, high-dose cytarabine, fluorouracil, intravenous mercaptopurine).\n\nAgents known to have serious unpredictable CNS side effects.\n\nEndocrine Therapy: Not specified.\n\nRadiotherapy: Recovery from toxic effects of prior radiotherapy required. Patient eligible if flow restored following focal radiotherapy to the blockage site.\n\nSurgery: Not specified.\n\nPATIENT CHARACTERISTICS:\n\nAge: 3 and over (older patients giving consent will be enrolled before the very young, if possible).\n\nPerformance status: ECOG 0-2.\n\nLife expectancy: At least 8 weeks.\n\nHematopoietic: See Disease Characteristics.\n\nHepatic: Bilirubin less than 2.0 mg/dL, SGPT less than 3 times normal.\n\nRenal: Creatinine less than 1.5 mg/dL.\n\nMetabolic: Serum electrolytes (including calcium and phosphate) normal.\n\nOther: No significant systemic illness (e.g., infection). Not pregnant or lactating."}, "IdentificationModule"=>{"NCTId"=>"NCT00001333", "BriefTitle"=>"Phase I Study of Intrathecal Topotecan", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Phase I Study of Intrathecal Topotecan", "OrgStudyIdInfo"=>{"OrgStudyId"=>"930085"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"93-C-0085"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"topotecan", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Cancer Institute (NCI)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Cancer Institute (NCI)", "LeadSponsorClass"=>"NIH"}}}}}}
