Nctid:
NCT00001249
Payload:
{"FullStudy"=>{"Rank"=>473175, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"November 27, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000008223", "ConditionMeshTerm"=>"Lymphoma"}, {"ConditionMeshId"=>"D000007938", "ConditionMeshTerm"=>"Leukemia"}, {"ConditionMeshId"=>"D000016399", "ConditionMeshTerm"=>"Lymphoma, T-Cell"}, {"ConditionMeshId"=>"D000015458", "ConditionMeshTerm"=>"Leukemia, T-Cell"}, {"ConditionMeshId"=>"D000015459", "ConditionMeshTerm"=>"Leukemia-Lymphoma, Adult T-Cell"}, {"ConditionMeshId"=>"D000016410", "ConditionMeshTerm"=>"Lymphoma, T-Cell, Cutaneous"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000009370", "ConditionAncestorTerm"=>"Neoplasms by Histologic Type"}, {"ConditionAncestorId"=>"D000009369", "ConditionAncestorTerm"=>"Neoplasms"}, {"ConditionAncestorId"=>"D000008232", "ConditionAncestorTerm"=>"Lymphoproliferative Disorders"}, {"ConditionAncestorId"=>"D000008206", "ConditionAncestorTerm"=>"Lymphatic Diseases"}, {"ConditionAncestorId"=>"D000007160", "ConditionAncestorTerm"=>"Immunoproliferative Disorders"}, {"ConditionAncestorId"=>"D000007154", "ConditionAncestorTerm"=>"Immune System Diseases"}, {"ConditionAncestorId"=>"D000008228", "ConditionAncestorTerm"=>"Lymphoma, Non-Hodgkin"}, {"ConditionAncestorId"=>"D000007945", "ConditionAncestorTerm"=>"Leukemia, Lymphoid"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M10635", "ConditionBrowseLeafName"=>"Leukemia", "ConditionBrowseLeafAsFound"=>"Leukemia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M10910", "ConditionBrowseLeafName"=>"Lymphoma", "ConditionBrowseLeafAsFound"=>"Lymphoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M18519", "ConditionBrowseLeafName"=>"Lymphoma, T-Cell", "ConditionBrowseLeafAsFound"=>"Lymphoma, T-Cell", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M18523", "ConditionBrowseLeafName"=>"Lymphoma, T-Cell, Peripheral", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18522", "ConditionBrowseLeafName"=>"Lymphoma, T-Cell, Cutaneous", "ConditionBrowseLeafAsFound"=>"Lymphoma, T-Cell, Cutaneous", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M17809", "ConditionBrowseLeafName"=>"Leukemia, T-Cell", "ConditionBrowseLeafAsFound"=>"Leukemia, T-Cell", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M17810", "ConditionBrowseLeafName"=>"Leukemia-Lymphoma, Adult T-Cell", "ConditionBrowseLeafAsFound"=>"Adult T-cell leukemia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M12005", "ConditionBrowseLeafName"=>"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10915", "ConditionBrowseLeafName"=>"Lymphoproliferative Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10893", "ConditionBrowseLeafName"=>"Lymphatic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9896", "ConditionBrowseLeafName"=>"Immunoproliferative Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9890", "ConditionBrowseLeafName"=>"Immune System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10912", "ConditionBrowseLeafName"=>"Lymphoma, Non-Hodgkin", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10641", "ConditionBrowseLeafName"=>"Leukemia, Lymphoid", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T3543", "ConditionBrowseLeafName"=>"Lymphosarcoma", "ConditionBrowseLeafAsFound"=>"Lymphoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T4496", "ConditionBrowseLeafName"=>"Peripheral T-cell Lymphoma", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T1689", "ConditionBrowseLeafName"=>"Cutaneous T-cell Lymphoma", "ConditionBrowseLeafAsFound"=>"Cutaneous T-Cell Lymphoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T224", "ConditionBrowseLeafName"=>"Adult T-cell Leukemia/lymphoma", "ConditionBrowseLeafAsFound"=>"Adult T-cell leukemia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T3393", "ConditionBrowseLeafName"=>"Leukemia, T-cell, Chronic", "ConditionBrowseLeafAsFound"=>"T-cell leukemia", "ConditionBrowseLeafRelevance"=>"high"}]}, "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"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000000906", "InterventionMeshTerm"=>"Antibodies"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000007155", "InterventionAncestorTerm"=>"Immunologic Factors"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M3915", "InterventionBrowseLeafName"=>"Antibodies", "InterventionBrowseLeafAsFound"=>"Use", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M9874", "InterventionBrowseLeafName"=>"Immunoglobulins", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M10101", "InterventionBrowseLeafName"=>"Interleukin-2", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M16664", "InterventionBrowseLeafName"=>"Triamcinolone", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M16665", "InterventionBrowseLeafName"=>"Triamcinolone Acetonide", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M237937", "InterventionBrowseLeafName"=>"Triamcinolone hexacetonide", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M209531", "InterventionBrowseLeafName"=>"Triamcinolone diacetate", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M1839", "InterventionBrowseLeafName"=>"Daclizumab", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9891", "InterventionBrowseLeafName"=>"Immunologic Factors", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"Analgesics", "InterventionBrowseBranchAbbrev"=>"Analg"}, {"InterventionBrowseBranchName"=>"Anti-Inflammatory Agents", "InterventionBrowseBranchAbbrev"=>"Infl"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"30"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"December 1989"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"November 1999", "CompletionDateStruct"=>{"CompletionDate"=>"October 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"=>["Interleukin-2 Receptor"]}, "ConditionList"=>{"Condition"=>["Leukemia, T-Cell", "Lymphoma, T-Cell, Cutaneous"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"2846094", "ReferenceType"=>"background", "ReferenceCitation"=>"Waldmann TA, Goldman CK, Bongiovanni KF, Sharrow SO, Davey MP, Cease KB, Greenberg SJ, Longo DL. Therapy of patients with human T-cell lymphotrophic virus I-induced adult T-cell leukemia with anti-Tac, a monoclonal antibody to the receptor for interleukin-2. Blood. 1988 Nov;72(5):1805-16."}, {"ReferencePMID"=>"2785435", "ReferenceType"=>"background", "ReferenceCitation"=>"Kozak RW, Raubitschek A, Mirzadeh S, Brechbiel MW, Junghans RP, Gansow OA, Waldmann TA. Nature of the bifunctional chelating agent used for radioimmunotherapy with yttrium-90 monoclonal antibodies: critical factors in determining in vivo survival and organ toxicity. Cancer Res. 1989 May 15;49(10):2639-44. Erratum In: Cancer Res 1999 Oct 15;59(20):5400. Junghaus R [corrected to Junghans RP]."}]}}, "DescriptionModule"=>{"BriefSummary"=>"The study purpose is to evaluate the clinical response to multidose administration of anti-Tac monoclonal antibody conjugated with 10 mCi 90Y in patients with Tac-expressing adult T-cell leukemia (ATL).", "DetailedDescription"=>"The study purpose is to evaluate the clinical response to multidose administration of anti-Tac monoclonal antibody conjugated with 10 mCi 90Y in patients with Tac-expressing adult T-cell leukemia (ATL). This study represents an extension of phase I trial (Clinical Project #90-C-0043, FDA IND #3469) which permitted the administration of 5 mCi, 10 mCi, and 15mCi 90Y-anti-Tac to patients with ATL. We propose to administer 90Y-anti-Tac (10 mCi doses) to patients with Tac-expressing ATL who are over 18 years of age and who fill the patient eligibility criteria."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\nHistologically confirmed adult T-cell leukemia/lymphoma (ATL) or cutaneous T-cell lymphoma (CTCL).\n\nReactivity of at least 10% of peripheral blood, lymph node, or dermal malignant cells with anti-Tac as determined by immunofluorescent staining or soluble IL-2 receptor level greater than 1,500 U required.\n\nAll stages of Tac-expressing T-cell leukemia and lymphoma eligible except Stage I CTCL.\n\nAll forms of ATL eligible, including the \"smoldering\" type as well as aggressive disease.\n\nNo symptomatic CNS disease other than tropical spastic paraparesis.\n\nAsymptomatic CNS disease with demonstrable malignant cells in the CSF allowed (such patients receive CNS therapy, e.g., intrathecal methotrexate and/or CNS irradiation, as appropriate).\n\nPRIOR/CONCURRENT THERAPY:\n\nBiologic Therapy: Not specified.\n\nChemotherapy:\n\nCTCL must have failed initial chemotherapy.\n\nATL may or may not have had prior chemotherapy.\n\nAt least 4 weeks since prior cytotoxic chemotherapy.\n\nEndocrine Therapy: Not specified.\n\nRadiotherapy: At least 4 weeks since prior radiotherapy.\n\nSurgery: Not specified.\n\nPATIENT CHARACTERISTICS:\n\nAge: 18 and over.\n\nPerformance status: Not specified.\n\nLife expectancy: Greater than 1 month.\n\nHematopoietic: WBC at least 3,000, Platelets at least 75,000.\n\nHepatic: Not specified.\n\nRenal: Not specified.\n\nOther:\n\nNo pregnant women.\n\nNegative pregnancy test required of fertile women."}, "IdentificationModule"=>{"NCTId"=>"NCT00001249", "BriefTitle"=>"Treatment of Tac-Expressing Cutaneous T-Cell Lymphoma (CTCL) and Adult T-Cell Leukemia (ATL) With Yttrium-90 Radiolabeled Anti-Tac", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Treatment of Tac-Expressing Cutaneous T-Cell Lymphoma (CTCL) and Adult T-Cell Leukemia (ATL) With Yttrium-90 Radiolabeled Anti-Tac", "OrgStudyIdInfo"=>{"OrgStudyId"=>"900043"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"90-C-0043"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Yttrium-90 radiolabeled anti-Tac antibody", "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"}}}}}}
