Nctid:
NCT00001271
Payload:
{"FullStudy"=>{"Rank"=>474365, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000008223", "ConditionMeshTerm"=>"Lymphoma"}, {"ConditionMeshId"=>"D000016393", "ConditionMeshTerm"=>"Lymphoma, B-Cell"}]}, "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"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M10910", "ConditionBrowseLeafName"=>"Lymphoma", "ConditionBrowseLeafAsFound"=>"Lymphoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M18518", "ConditionBrowseLeafName"=>"Lymphoma, B-Cell", "ConditionBrowseLeafAsFound"=>"B-cell Lymphoma", "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"=>"T3543", "ConditionBrowseLeafName"=>"Lymphosarcoma", "ConditionBrowseLeafAsFound"=>"Lymphoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T640", "ConditionBrowseLeafName"=>"B-cell Lymphoma", "ConditionBrowseLeafAsFound"=>"B-cell Lymphoma", "ConditionBrowseLeafRelevance"=>"high"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"Blood and Lymph Conditions", "ConditionBrowseBranchAbbrev"=>"BC15"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M3931", "InterventionBrowseLeafName"=>"Immunotoxins", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"24"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"July 1991"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"June 2000", "CompletionDateStruct"=>{"CompletionDate"=>"April 2001"}, "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"=>["Antigen Modulation", "Pharmacokinetics", "Ricin A Chain"]}, "ConditionList"=>{"Condition"=>["B Cell Lymphoma"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"3317828", "ReferenceType"=>"background", "ReferenceCitation"=>"Vitetta ES, Fulton RJ, May RD, Till M, Uhr JW. Redesigning nature's poisons to create anti-tumor reagents. Science. 1987 Nov 20;238(4830):1098-104. doi: 10.1126/science.3317828."}, {"ReferencePMID"=>"2982609", "ReferenceType"=>"background", "ReferenceCitation"=>"Thorpe PE, Detre SI, Foxwell BM, Brown AN, Skilleter DN, Wilson G, Forrester JA, Stirpe F. Modification of the carbohydrate in ricin with metaperiodate-cyanoborohydride mixtures. Effects on toxicity and in vivo distribution. Eur J Biochem. 1985 Feb 15;147(1):197-206. doi: 10.1111/j.1432-1033.1985.tb08737.x."}, {"ReferencePMID"=>"3263328", "ReferenceType"=>"background", "ReferenceCitation"=>"Shen GL, Li JL, Ghetie MA, Ghetie V, May RD, Till M, Brown AN, Relf M, Knowles P, Uhr JW, et al. Evaluation of four CD22 antibodies as ricin A chain-containing immunotoxins for the in vivo therapy of human B-cell leukemias and lymphomas. Int J Cancer. 1988 Nov 15;42(5):792-7. doi: 10.1002/ijc.2910420527."}]}}, "DescriptionModule"=>{"BriefSummary"=>"Patients with CD22(+) B-cell lymphomas will be treated with escalating doses as a 192 hr infusion of immunotoxin in a Phase I study to determine dose limiting toxicity evidence of response.", "DetailedDescription"=>"Patients with CD22(+) B-cell lymphomas will be treated with escalating doses as a 192 hr infusion of immunotoxin in a Phase I study to determine dose limiting toxicity evidence of response."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Patients with a histologic diagnosis confirmed from a pretreatment biopsy at the Laboratory of Pathology, NCI of one of the following entities: Diffuse small Lymphocytic Lymphoma; Follicular, Small Cleaved cell Lymphoma; Follicular, Mixed Small Cleaved and Large Cell Lymphoma; Follicular Large Cell Lymphoma; Diffuse, Intermediately Differentiated Lymphocytic Lymphoma; Diffuse, Small Cleaved Cell Lymphoma; Diffuse, Mixed Small and Large Cell Lymphoma; Diffuse, Large Cell Lymphoma; Large Cell Immunoblastic Lymphoma; Small Noncleaved Cell Lymphoma.\n\nPresence of CD22 antigen on at least 30 percent of tumor cells.\n\nPresence of objectively measurable sites of disease. Bone marrow positivity and circulating tumor cells in the peripheral blood will be considered evaluable but not measurable disease.\n\nNo patients with purely B-cell Lymphosarcoma cell leukemia without nodal or soft tissue involvement.\n\nNo patients with B-cell chronic lymphocytic leukemia, or B-cell or pre-B-cell acute lymphocytic leukemia, and hairy cell leukemia.\n\nPatients with objectively measurable disease outside a radiation port or disease which has clearly progressed within a radiation port.\n\nHIV negative.\n\nNo CNS disease.\n\nNo pulmonary parenchymal disease.\n\nPleural effusions or ascites may be present.\n\nPatients with progression of disease despite at least one standard combination chemotherapy regimen.\n\nNo chemotherapy for at least two weeks prior to entry.\n\nPatients who do not desire or are not candidates for autologous or allogeneic bone marrow transplantation procedures.\n\nLife expectancy of at least 3 months\n\nCreatinine clearance greater than 60 cc per minute.\n\nTotal bilirubin less than 1.5 mg/dl.\n\nSGPT less than 2 times the upper limit of normal.\n\nAlbumin greater than 75 percent of the lower limit of normal.\n\nIf prior treatment with doxorubicin, the radionuclide or echocardiogram ejection fraction shall be at least 35 percent.\n\nPerformance status 0-2.\n\nNot in need of current radiation therapy to alleviate local problems.\n\nNo prior exposure to murine antibodies.\n\nNo need for current corticosteroid treatment."}, "IdentificationModule"=>{"NCTId"=>"NCT00001271", "BriefTitle"=>"A Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"A Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma", "OrgStudyIdInfo"=>{"OrgStudyId"=>"910176"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"91-C-0176"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"IgG-RFB4-SMPT-dgA", "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"}}}}}}
