Nctid:
NCT00001880
Payload:
{"FullStudy"=>{"Rank"=>473893, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000009369", "ConditionMeshTerm"=>"Neoplasms"}, {"ConditionMeshId"=>"D000009362", "ConditionMeshTerm"=>"Neoplasm Metastasis"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000009385", "ConditionAncestorTerm"=>"Neoplastic Processes"}, {"ConditionAncestorId"=>"D000010335", "ConditionAncestorTerm"=>"Pathologic Processes"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M8879", "ConditionBrowseLeafName"=>"Graft vs Host Disease", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11997", "ConditionBrowseLeafName"=>"Neoplasm Metastasis", "ConditionBrowseLeafAsFound"=>"Neoplasm Metastasis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M12020", "ConditionBrowseLeafName"=>"Neoplastic Processes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T2832", "ConditionBrowseLeafName"=>"Homologous Wasting Disease", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000016572", "InterventionMeshTerm"=>"Cyclosporine"}, {"InterventionMeshId"=>"D000008727", "InterventionMeshTerm"=>"Methotrexate"}, {"InterventionMeshId"=>"D000003524", "InterventionMeshTerm"=>"Cyclosporins"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000020", "InterventionAncestorTerm"=>"Abortifacient Agents, Nonsteroidal"}, {"InterventionAncestorId"=>"D000000019", "InterventionAncestorTerm"=>"Abortifacient Agents"}, {"InterventionAncestorId"=>"D000012102", "InterventionAncestorTerm"=>"Reproductive Control Agents"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000000964", "InterventionAncestorTerm"=>"Antimetabolites, Antineoplastic"}, {"InterventionAncestorId"=>"D000000963", "InterventionAncestorTerm"=>"Antimetabolites"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000000970", "InterventionAncestorTerm"=>"Antineoplastic Agents"}, {"InterventionAncestorId"=>"D000003879", "InterventionAncestorTerm"=>"Dermatologic Agents"}, {"InterventionAncestorId"=>"D000004791", "InterventionAncestorTerm"=>"Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000005493", "InterventionAncestorTerm"=>"Folic Acid Antagonists"}, {"InterventionAncestorId"=>"D000007166", "InterventionAncestorTerm"=>"Immunosuppressive Agents"}, {"InterventionAncestorId"=>"D000007155", "InterventionAncestorTerm"=>"Immunologic Factors"}, {"InterventionAncestorId"=>"D000018501", "InterventionAncestorTerm"=>"Antirheumatic Agents"}, {"InterventionAncestorId"=>"D000019384", "InterventionAncestorTerm"=>"Nucleic Acid Synthesis Inhibitors"}, {"InterventionAncestorId"=>"D000000935", "InterventionAncestorTerm"=>"Antifungal Agents"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"InterventionAncestorId"=>"D000065095", "InterventionAncestorTerm"=>"Calcineurin Inhibitors"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M11393", "InterventionBrowseLeafName"=>"Methotrexate", "InterventionBrowseLeafAsFound"=>"Multiple", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M18651", "InterventionBrowseLeafName"=>"Cyclosporine", "InterventionBrowseLeafAsFound"=>"Magnetic", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M6420", "InterventionBrowseLeafName"=>"Cyclosporins", "InterventionBrowseLeafAsFound"=>"Magnetic", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3971", "InterventionBrowseLeafName"=>"Antimetabolites", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M6764", "InterventionBrowseLeafName"=>"Dermatologic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7641", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17236", "InterventionBrowseLeafName"=>"Vitamin B Complex", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M8308", "InterventionBrowseLeafName"=>"Folic Acid", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M8309", "InterventionBrowseLeafName"=>"Folic Acid Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9902", "InterventionBrowseLeafName"=>"Immunosuppressive Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9891", "InterventionBrowseLeafName"=>"Immunologic Factors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20294", "InterventionBrowseLeafName"=>"Antirheumatic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3944", "InterventionBrowseLeafName"=>"Antifungal Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M5942", "InterventionBrowseLeafName"=>"Clotrimazole", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M11486", "InterventionBrowseLeafName"=>"Miconazole", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3904", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M30142", "InterventionBrowseLeafName"=>"Calcineurin Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T448", "InterventionBrowseLeafName"=>"Folate", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T447", "InterventionBrowseLeafName"=>"Folinic Acid", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T446", "InterventionBrowseLeafName"=>"Folic Acid", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T475", "InterventionBrowseLeafName"=>"Vitamin B9", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"Antirheumatic Agents", "InterventionBrowseBranchAbbrev"=>"ARhu"}, {"InterventionBrowseBranchName"=>"Dermatologic Agents", "InterventionBrowseBranchAbbrev"=>"Derm"}, {"InterventionBrowseBranchName"=>"Reproductive Control Agents", "InterventionBrowseBranchAbbrev"=>"Repr"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"Micronutrients", "InterventionBrowseBranchAbbrev"=>"Micro"}, {"InterventionBrowseBranchName"=>"Hematinics", "InterventionBrowseBranchAbbrev"=>"Hemat"}, {"InterventionBrowseBranchName"=>"Vitamins", "InterventionBrowseBranchAbbrev"=>"Vi"}]}}}, "ResultsSection"=>{"MoreInfoModule"=>{"PointOfContact"=>{"PointOfContactEMail"=>"childsr@nhlbi.nih.gov", "PointOfContactPhone"=>"301.451.7128", "PointOfContactTitle"=>"Richard Childs, M.D. Principal Investigator, NIH, NHLBI", "PointOfContactOrganization"=>"National Heart Lung and Blood Institute (NHLBI)"}, "CertainAgreement"=>{"AgreementPISponsorEmployee"=>"Yes"}}, "AdverseEventsModule"=>{"EventGroupList"=>{"EventGroup"=>[{"EventGroupId"=>"EG000", "EventGroupTitle"=>"Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors", "EventGroupDescription"=>"CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given\n\nmethotrexate: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given\n\ncyclosporin: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given", "EventGroupOtherNumAtRisk"=>"42", "EventGroupDeathsNumAtRisk"=>"42", "EventGroupOtherNumAffected"=>"7", "EventGroupSeriousNumAtRisk"=>"42", "EventGroupDeathsNumAffected"=>"14", "EventGroupSeriousNumAffected"=>"21"}]}, "OtherEventList"=>{"OtherEvent"=>[{"OtherEventTerm"=>"Hemorrhagic cystitis", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"42", "OtherEventStatsNumAffected"=>"4"}]}, "OtherEventOrganSystem"=>"Renal and urinary disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCAE (Unspecified)"}, {"OtherEventTerm"=>"Cytomegalovirus disease", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"42", "OtherEventStatsNumAffected"=>"3"}]}, "OtherEventOrganSystem"=>"Infections and infestations", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCAE (Unspecified)"}]}, "EventsTimeFrame"=>"8.5 years", "SeriousEventList"=>{"SeriousEvent"=>[{"SeriousEventTerm"=>"Mucositis with fever", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"42", "SeriousEventStatsNumEvents"=>"2", "SeriousEventStatsNumAffected"=>"2"}]}, "SeriousEventOrganSystem"=>"Gastrointestinal disorders", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCAE (Unspecified)"}, {"SeriousEventTerm"=>"Pseudomonas sepsis", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"42", "SeriousEventStatsNumEvents"=>"1", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"Infections and infestations", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCAE (Unspecified)"}, {"SeriousEventTerm"=>"Parainfluenza pneumonia and septic shock", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"42", "SeriousEventStatsNumEvents"=>"1", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"Infections and infestations", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCAE (Unspecified)"}, {"SeriousEventTerm"=>"Pulmonary aspergillus", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"42", "SeriousEventStatsNumEvents"=>"1", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"Infections and infestations", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCAE (Unspecified)"}, {"SeriousEventTerm"=>"Dyspnea with progressive mets to lungs", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"42", "SeriousEventStatsNumEvents"=>"1", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"Respiratory, thoracic and mediastinal disorders", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCAE (Unspecified)"}, {"SeriousEventTerm"=>"Fecal impaction", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"42", "SeriousEventStatsNumEvents"=>"1", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"Gastrointestinal disorders", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCAE (Unspecified)"}, {"SeriousEventTerm"=>"Community acquired pneumonia", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"42", "SeriousEventStatsNumEvents"=>"1", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"Infections and infestations", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCAE (Unspecified)"}, {"SeriousEventTerm"=>"Pneumonia", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"42", "SeriousEventStatsNumEvents"=>"1", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"Infections and infestations", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCAE (Unspecified)"}, {"SeriousEventTerm"=>"Progressive disease", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"42", "SeriousEventStatsNumEvents"=>"12", "SeriousEventStatsNumAffected"=>"12"}]}, "SeriousEventOrganSystem"=>"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCAE (Unspecified)"}, {"SeriousEventTerm"=>"Acute Graft VS Host Disease of GI Tract", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"42", "SeriousEventStatsNumEvents"=>"4", "SeriousEventStatsNumAffected"=>"4"}]}, "SeriousEventOrganSystem"=>"Gastrointestinal disorders", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCAE (Unspecified)"}, {"SeriousEventTerm"=>"Cytomegalovirus colitis", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"42", "SeriousEventStatsNumEvents"=>"2", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"Gastrointestinal disorders", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCAE (Unspecified)"}, {"SeriousEventTerm"=>"Invasive fungal infection", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"42", "SeriousEventStatsNumEvents"=>"1", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"Infections and infestations", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCAE (Unspecified)"}, {"SeriousEventTerm"=>"Acute nephrotoxicity", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"42", "SeriousEventStatsNumEvents"=>"2", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"Renal and urinary disorders", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCAE (Unspecified)"}, {"SeriousEventTerm"=>"Acute Respiratory Distress", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"42", "SeriousEventStatsNumEvents"=>"1", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"Infections and infestations", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCAE (Unspecified)"}, {"SeriousEventTerm"=>"Liver Failure", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"42", "SeriousEventStatsNumEvents"=>"1", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"Hepatobiliary disorders", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCAE (Unspecified)"}]}, "EventsFrequencyThreshold"=>"5"}, "OutcomeMeasuresModule"=>{"OutcomeMeasureList"=>{"OutcomeMeasure"=>[{"OutcomeClassList"=>{"OutcomeClass"=>[{"OutcomeCategoryList"=>{"OutcomeCategory"=>[{"OutcomeCategoryTitle"=>"Complete response (CR)", "OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"0", "OutcomeMeasurementGroupId"=>"OG000"}]}}, {"OutcomeCategoryTitle"=>"Partial response (PR)", "OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"9", "OutcomeMeasurementGroupId"=>"OG000"}]}}, {"OutcomeCategoryTitle"=>"Stable disease (SD):", "OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"5", "OutcomeMeasurementGroupId"=>"OG000"}]}}, {"OutcomeCategoryTitle"=>"Progressive disease (PD)", "OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"28", "OutcomeMeasurementGroupId"=>"OG000"}]}}]}}]}, "OutcomeDenomList"=>{"OutcomeDenom"=>[{"OutcomeDenomUnits"=>"Participants", "OutcomeDenomCountList"=>{"OutcomeDenomCount"=>[{"OutcomeDenomCountValue"=>"42", "OutcomeDenomCountGroupId"=>"OG000"}]}}]}, "OutcomeGroupList"=>{"OutcomeGroup"=>[{"OutcomeGroupId"=>"OG000", "OutcomeGroupTitle"=>"Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors", "OutcomeGroupDescription"=>"CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given\n\nmethotrexate: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given\n\ncyclosporin: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given"}]}, "OutcomeMeasureType"=>"Primary", "OutcomeMeasureTitle"=>"Number of Participants Based on Tumor Response Criteria With Anti-tumor Effect Induce by Graft-versus-tumor Effect.", "OutcomeMeasureParamType"=>"Count of Participants", "OutcomeMeasureTimeFrame"=>"one year", "OutcomeMeasureDescription"=>"To identify an anti-tumor effect of allogenic PNSC transplantation by induction of a graft-versus-tumor (GVT) effect in patients with a diversity of metastatic solid tumors, which are refractory to standard therapy.\n\nTumor response assessed as follows:\n\nComplete response (CR): disappearance of all signs and symptoms of metastatic disease for a period of at least one month.\n\nPartial response (PR): a 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions lasting for a period of at least one month. No new metastatic lesions may appear.\n\nStable disease (SD): tumor measurements not meeting the criteria of CR, PR, or PD.\n\nProgressive disease (PD): increase of 25% or greater in the sum of the products of the longest perpendicular diameters of all measured lesions compared to the smallest previous measurements, or the development of any new metastatic disease.", "OutcomeMeasureUnitOfMeasure"=>"Participants", "OutcomeMeasureReportingStatus"=>"Posted"}, {"OutcomeClassList"=>{"OutcomeClass"=>[{"OutcomeCategoryList"=>{"OutcomeCategory"=>[{"OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"31", "OutcomeMeasurementGroupId"=>"OG000"}]}}]}}]}, "OutcomeDenomList"=>{"OutcomeDenom"=>[{"OutcomeDenomUnits"=>"Participants", "OutcomeDenomCountList"=>{"OutcomeDenomCount"=>[{"OutcomeDenomCountValue"=>"33", "OutcomeDenomCountGroupId"=>"OG000"}]}}]}, "OutcomeGroupList"=>{"OutcomeGroup"=>[{"OutcomeGroupId"=>"OG000", "OutcomeGroupTitle"=>"Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors", "OutcomeGroupDescription"=>"CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given\n\nmethotrexate: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given\n\ncyclosporin: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given"}]}, "OutcomeMeasureType"=>"Secondary", "OutcomeMeasureTitle"=>"Number of Participants That Achieved Engraftment", "OutcomeMeasureParamType"=>"Count of Participants", "OutcomeMeasureTimeFrame"=>"Day 100", "OutcomeMeasureDescription"=>"Number of participants that achieved engraftment based on blood Chimerism Cluster of differentiation 3 (CD3) analysis that is greater than or equal to 95%.", "OutcomeMeasureUnitOfMeasure"=>"Participants", "OutcomeMeasureReportingStatus"=>"Posted", "OutcomeMeasurePopulationDescription"=>"9 participants data was not evaluable"}, {"OutcomeClassList"=>{"OutcomeClass"=>[{"OutcomeCategoryList"=>{"OutcomeCategory"=>[{"OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"16", "OutcomeMeasurementGroupId"=>"OG000"}]}}]}}]}, "OutcomeDenomList"=>{"OutcomeDenom"=>[{"OutcomeDenomUnits"=>"Participants", "OutcomeDenomCountList"=>{"OutcomeDenomCount"=>[{"OutcomeDenomCountValue"=>"42", "OutcomeDenomCountGroupId"=>"OG000"}]}}]}, "OutcomeGroupList"=>{"OutcomeGroup"=>[{"OutcomeGroupId"=>"OG000", "OutcomeGroupTitle"=>"Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors", "OutcomeGroupDescription"=>"CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given\n\nmethotrexate: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given\n\ncyclosporin: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given"}]}, "OutcomeMeasureType"=>"Secondary", "OutcomeMeasureTitle"=>"Number of Participants Who Received Donor Lymphocyte Infusion to Achieve Tumor Regression or Prevent Graft Failure", "OutcomeMeasureParamType"=>"Count of Participants", "OutcomeMeasureTimeFrame"=>"2 years", "OutcomeMeasureDescription"=>"To evaluate the effects of donor lymphocyte infusion (DLI) and cyclosporine A (CSA) withdrawal on tumor regression in participants who show progressive disease off of CSA and in the absence of grade > II GVHD, or who are at risk for graft failure due to incomplete donor T-cell engraftment will receive one or more DLI.\n\nTumor response assessed as follows:\n\nComplete response (CR): disappearance of signs & symptoms of metastatic disease at least one month.\n\nPartial response (PR): a 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions lasting at least one month. No new metastatic lesions may appear.\n\nStable disease (SD): tumor measurements not meeting the criteria of CR, PR, or PD.\n\nProgressive disease (PD): increase of 25% or greater in the sum of the products of the longest perpendicular diameters of all measured lesions compared to the smallest previous measurements, or development of new metastatic disease.", "OutcomeMeasureUnitOfMeasure"=>"Participants", "OutcomeMeasureReportingStatus"=>"Posted"}, {"OutcomeClassList"=>{"OutcomeClass"=>[{"OutcomeCategoryList"=>{"OutcomeCategory"=>[{"OutcomeCategoryTitle"=>"Grade II", "OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"9", "OutcomeMeasurementGroupId"=>"OG000"}]}}, {"OutcomeCategoryTitle"=>"Grade III-IV", "OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"11", "OutcomeMeasurementGroupId"=>"OG000"}]}}, {"OutcomeCategoryTitle"=>"No Acute GVHD", "OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"22", "OutcomeMeasurementGroupId"=>"OG000"}]}}]}}]}, "OutcomeDenomList"=>{"OutcomeDenom"=>[{"OutcomeDenomUnits"=>"Participants", "OutcomeDenomCountList"=>{"OutcomeDenomCount"=>[{"OutcomeDenomCountValue"=>"42", "OutcomeDenomCountGroupId"=>"OG000"}]}}]}, "OutcomeGroupList"=>{"OutcomeGroup"=>[{"OutcomeGroupId"=>"OG000", "OutcomeGroupTitle"=>"Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors", "OutcomeGroupDescription"=>"CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given\n\nmethotrexate: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given\n\ncyclosporin: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given"}]}, "OutcomeMeasureType"=>"Secondary", "OutcomeMeasureTitle"=>"Number of Participants Who Developed Acute GVHD Grade 2 and Higher", "OutcomeMeasureParamType"=>"Count of Participants", "OutcomeMeasureTimeFrame"=>"Day 100", "OutcomeMeasureDescription"=>"Number of participants who developed Acute Graft vs Host Disease (GVHD) Grades I, II, III, IV as defined by CIMBTR criteria for Organ Stages of Acute GVHD.\n\nGrades are defined as:\n\nGrade I: Skin = Maculopapular rash< 25% of body surface area (BSA); Liver = Total Bilirubin 2-3 mg/dL; Lower GI = stool output/day is 500-999 mL/day.\n\nGrade II: Skin = rash on 25-50 percent body surface area; Liver = Total Bilirubin 3.1-6.0 mg/dL; Lower GI = Diarrhea 1001-1500 mL/day.\n\nGrade III: Skin = Rash on >50% of body surface; Liver = Total Bilirubin 6.1 - 15.0 mg/dL; Lower GI = Diarrhea > 1500 mL/day.\n\nGrade IV: Skin = Generalized erythroderma plus bullous formation; Liver = Total Bilirubin >15 mg/dL; Lower GI = Severe abdominal pain with or without ileus.\n\nGrade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening.", "OutcomeMeasureUnitOfMeasure"=>"Participants", "OutcomeMeasureReportingStatus"=>"Posted"}, {"OutcomeClassList"=>{"OutcomeClass"=>[{"OutcomeCategoryList"=>{"OutcomeCategory"=>[{"OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"18", "OutcomeMeasurementGroupId"=>"OG000"}]}}]}}]}, "OutcomeDenomList"=>{"OutcomeDenom"=>[{"OutcomeDenomUnits"=>"Participants", "OutcomeDenomCountList"=>{"OutcomeDenomCount"=>[{"OutcomeDenomCountValue"=>"41", "OutcomeDenomCountGroupId"=>"OG000"}]}}]}, "OutcomeGroupList"=>{"OutcomeGroup"=>[{"OutcomeGroupId"=>"OG000", "OutcomeGroupTitle"=>"Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors", "OutcomeGroupDescription"=>"CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given\n\nmethotrexate: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given\n\ncyclosporin: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given"}]}, "OutcomeMeasureType"=>"Secondary", "OutcomeMeasureTitle"=>"Number of Participants Who Developed Chronic GVHD", "OutcomeMeasureParamType"=>"Count of Participants", "OutcomeMeasureTimeFrame"=>"Day 100 to year 2", "OutcomeMeasureDescription"=>"Number of participants who developed Chronic Graft vs Host Disease (GVHD).\n\nChronic GVHD is defined as symptoms that persist or appear after 100 days since the time of stem cell transplantation.", "OutcomeMeasureUnitOfMeasure"=>"Participants", "OutcomeMeasureReportingStatus"=>"Posted", "OutcomeMeasurePopulationDescription"=>"1 participant passed away prior to day 100 therefore is not evaluable."}]}}, "ParticipantFlowModule"=>{"FlowGroupList"=>{"FlowGroup"=>[{"FlowGroupId"=>"FG000", "FlowGroupTitle"=>"Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors", "FlowGroupDescription"=>"CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given\n\nmethotrexate: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given\n\ncyclosporin: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given"}]}, "FlowPeriodList"=>{"FlowPeriod"=>[{"FlowPeriodTitle"=>"Overall Study", "FlowMilestoneList"=>{"FlowMilestone"=>[{"FlowMilestoneType"=>"STARTED", "FlowAchievementList"=>{"FlowAchievement"=>[{"FlowAchievementGroupId"=>"FG000", "FlowAchievementNumSubjects"=>"42"}]}}, {"FlowMilestoneType"=>"COMPLETED", "FlowAchievementList"=>{"FlowAchievement"=>[{"FlowAchievementGroupId"=>"FG000", "FlowAchievementNumSubjects"=>"28"}]}}, {"FlowMilestoneType"=>"NOT COMPLETED", "FlowAchievementList"=>{"FlowAchievement"=>[{"FlowAchievementGroupId"=>"FG000", "FlowAchievementNumSubjects"=>"14"}]}}]}, "FlowDropWithdrawList"=>{"FlowDropWithdraw"=>[{"FlowReasonList"=>{"FlowReason"=>[{"FlowReasonGroupId"=>"FG000", "FlowReasonNumSubjects"=>"14"}]}, "FlowDropWithdrawType"=>"Death"}]}}]}, "FlowRecruitmentDetails"=>"Study was closed early due to lack of accrual"}, "BaselineCharacteristicsModule"=>{"BaselineDenomList"=>{"BaselineDenom"=>[{"BaselineDenomUnits"=>"Participants", "BaselineDenomCountList"=>{"BaselineDenomCount"=>[{"BaselineDenomCountValue"=>"42", "BaselineDenomCountGroupId"=>"BG000"}]}}]}, "BaselineGroupList"=>{"BaselineGroup"=>[{"BaselineGroupId"=>"BG000", "BaselineGroupTitle"=>"Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors", "BaselineGroupDescription"=>"CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given\n\nmethotrexate: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given\n\ncyclosporin: CSA beginning day -4 and intravenous MTX on days +1, +3, and +6 will be given"}]}, "BaselineMeasureList"=>{"BaselineMeasure"=>[{"BaselineClassList"=>{"BaselineClass"=>[{"BaselineClassTitle"=>"Male", "BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"55", "BaselineMeasurementGroupId"=>"BG000", "BaselineMeasurementLowerLimit"=>"24", "BaselineMeasurementUpperLimit"=>"67"}]}}]}, "BaselineClassDenomList"=>{"BaselineClassDenom"=>[{"BaselineClassDenomUnits"=>"Participants", "BaselineClassDenomCountList"=>{"BaselineClassDenomCount"=>[{"BaselineClassDenomCountValue"=>"22", "BaselineClassDenomCountGroupId"=>"BG000"}]}}]}}, {"BaselineClassTitle"=>"Female", "BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"45", "BaselineMeasurementGroupId"=>"BG000", "BaselineMeasurementLowerLimit"=>"28", "BaselineMeasurementUpperLimit"=>"65"}]}}]}, "BaselineClassDenomList"=>{"BaselineClassDenom"=>[{"BaselineClassDenomUnits"=>"Participants", "BaselineClassDenomCountList"=>{"BaselineClassDenomCount"=>[{"BaselineClassDenomCountValue"=>"20", "BaselineClassDenomCountGroupId"=>"BG000"}]}}]}}]}, "BaselineMeasureTitle"=>"Age, Continuous", "BaselineMeasureParamType"=>"Median", "BaselineMeasureUnitOfMeasure"=>"years", "BaselineMeasureDispersionType"=>"Full Range", "BaselineMeasurePopulationDescription"=>"22 male participants and 20 female participants for total of 42 participants"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineCategoryTitle"=>"Female", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"20", "BaselineMeasurementGroupId"=>"BG000"}]}}, {"BaselineCategoryTitle"=>"Male", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"22", "BaselineMeasurementGroupId"=>"BG000"}]}}]}, "BaselineClassDenomList"=>{"BaselineClassDenom"=>[{"BaselineClassDenomUnits"=>"Participants", "BaselineClassDenomCountList"=>{"BaselineClassDenomCount"=>[{"BaselineClassDenomCountValue"=>"42", "BaselineClassDenomCountGroupId"=>"BG000"}]}}]}}]}, "BaselineMeasureTitle"=>"Sex: Female, Male", "BaselineMeasureParamType"=>"Count of Participants", "BaselineMeasureUnitOfMeasure"=>"Participants"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineCategoryTitle"=>"Hispanic or Latino", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"1", "BaselineMeasurementGroupId"=>"BG000"}]}}, {"BaselineCategoryTitle"=>"Not Hispanic or Latino", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"41", "BaselineMeasurementGroupId"=>"BG000"}]}}, {"BaselineCategoryTitle"=>"Unknown or Not Reported", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG000"}]}}]}, "BaselineClassDenomList"=>{"BaselineClassDenom"=>[{"BaselineClassDenomUnits"=>"Participants", "BaselineClassDenomCountList"=>{"BaselineClassDenomCount"=>[{"BaselineClassDenomCountValue"=>"42", "BaselineClassDenomCountGroupId"=>"BG000"}]}}]}}]}, "BaselineMeasureTitle"=>"Ethnicity (NIH/OMB)", "BaselineMeasureParamType"=>"Count of Participants", "BaselineMeasureUnitOfMeasure"=>"Participants"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineCategoryTitle"=>"American Indian or Alaska Native", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG000"}]}}, {"BaselineCategoryTitle"=>"Asian", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG000"}]}}, {"BaselineCategoryTitle"=>"Native Hawaiian or Other Pacific Islander", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG000"}]}}, {"BaselineCategoryTitle"=>"Black or African American", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"3", "BaselineMeasurementGroupId"=>"BG000"}]}}, {"BaselineCategoryTitle"=>"White", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"37", "BaselineMeasurementGroupId"=>"BG000"}]}}, {"BaselineCategoryTitle"=>"More than one race", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG000"}]}}, {"BaselineCategoryTitle"=>"Unknown or Not Reported", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"2", "BaselineMeasurementGroupId"=>"BG000"}]}}]}, "BaselineClassDenomList"=>{"BaselineClassDenom"=>[{"BaselineClassDenomUnits"=>"Participants", "BaselineClassDenomCountList"=>{"BaselineClassDenomCount"=>[{"BaselineClassDenomCountValue"=>"42", "BaselineClassDenomCountGroupId"=>"BG000"}]}}]}}]}, "BaselineMeasureTitle"=>"Race (NIH/OMB)", "BaselineMeasureParamType"=>"Count of Participants", "BaselineMeasureUnitOfMeasure"=>"Participants"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineClassTitle"=>"United States", "BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"42", "BaselineMeasurementGroupId"=>"BG000"}]}}]}, "BaselineClassDenomList"=>{"BaselineClassDenom"=>[{"BaselineClassDenomUnits"=>"Participants", "BaselineClassDenomCountList"=>{"BaselineClassDenomCount"=>[{"BaselineClassDenomCountValue"=>"42", "BaselineClassDenomCountGroupId"=>"BG000"}]}}]}}]}, "BaselineMeasureTitle"=>"Region of Enrollment", "BaselineMeasureParamType"=>"Number", "BaselineMeasureUnitOfMeasure"=>"participants"}]}}}, "DocumentSection"=>{"LargeDocumentModule"=>{"LargeDocList"=>{"LargeDoc"=>[{"LargeDocDate"=>"July 23, 2019", "LargeDocLabel"=>"Study Protocol and Statistical Analysis Plan", "LargeDocHasICF"=>"No", "LargeDocHasSAP"=>"Yes", "LargeDocFilename"=>"Prot_SAP_000.pdf", "LargeDocTypeAbbrev"=>"Prot_SAP", "LargeDocUploadDate"=>"04/09/2021 14:32", "LargeDocHasProtocol"=>"Yes"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"N/A", "DesignMaskingInfo"=>{"DesignMasking"=>"None (Open Label)"}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Single Group Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"42"}}, "StatusModule"=>{"WhyStopped"=>"Study was closed early due to lack of accrual", "OverallStatus"=>"Terminated", "StartDateStruct"=>{"StartDate"=>"March 12, 1999", "StartDateType"=>"Actual"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"August 2020", "CompletionDateStruct"=>{"CompletionDate"=>"August 13, 2020", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"November 8, 2021", "StudyFirstSubmitDate"=>"July 3, 2006", "ResultsFirstSubmitDate"=>"September 13, 2021", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"November 10, 2021", "LastUpdatePostDateType"=>"Actual"}, "ResultsFirstSubmitQCDate"=>"November 8, 2021", "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}, "ResultsFirstPostDateStruct"=>{"ResultsFirstPostDate"=>"November 10, 2021", "ResultsFirstPostDateType"=>"Actual"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"August 14, 2008", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Number of Participants Based on Tumor Response Criteria With Anti-tumor Effect Induce by Graft-versus-tumor Effect.", "PrimaryOutcomeTimeFrame"=>"one year", "PrimaryOutcomeDescription"=>"To identify an anti-tumor effect of allogenic PNSC transplantation by induction of a graft-versus-tumor (GVT) effect in patients with a diversity of metastatic solid tumors, which are refractory to standard therapy.\n\nTumor response assessed as follows:\n\nComplete response (CR): disappearance of all signs and symptoms of metastatic disease for a period of at least one month.\n\nPartial response (PR): a 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions lasting for a period of at least one month. No new metastatic lesions may appear.\n\nStable disease (SD): tumor measurements not meeting the criteria of CR, PR, or PD.\n\nProgressive disease (PD): increase of 25% or greater in the sum of the products of the longest perpendicular diameters of all measured lesions compared to the smallest previous measurements, or the development of any new metastatic disease."}]}, "SecondaryOutcomeList"=>{"SecondaryOutcome"=>[{"SecondaryOutcomeMeasure"=>"Number of Participants That Achieved Engraftment", "SecondaryOutcomeTimeFrame"=>"Day 100", "SecondaryOutcomeDescription"=>"Number of participants that achieved engraftment based on blood Chimerism Cluster of differentiation 3 (CD3) analysis that is greater than or equal to 95%."}, {"SecondaryOutcomeMeasure"=>"Number of Participants Who Received Donor Lymphocyte Infusion to Achieve Tumor Regression or Prevent Graft Failure", "SecondaryOutcomeTimeFrame"=>"2 years", "SecondaryOutcomeDescription"=>"To evaluate the effects of donor lymphocyte infusion (DLI) and cyclosporine A (CSA) withdrawal on tumor regression in participants who show progressive disease off of CSA and in the absence of grade > II GVHD, or who are at risk for graft failure due to incomplete donor T-cell engraftment will receive one or more DLI.\n\nTumor response assessed as follows:\n\nComplete response (CR): disappearance of signs & symptoms of metastatic disease at least one month.\n\nPartial response (PR): a 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions lasting at least one month. No new metastatic lesions may appear.\n\nStable disease (SD): tumor measurements not meeting the criteria of CR, PR, or PD.\n\nProgressive disease (PD): increase of 25% or greater in the sum of the products of the longest perpendicular diameters of all measured lesions compared to the smallest previous measurements, or development of new metastatic disease."}, {"SecondaryOutcomeMeasure"=>"Number of Participants Who Developed Acute GVHD Grade 2 and Higher", "SecondaryOutcomeTimeFrame"=>"Day 100", "SecondaryOutcomeDescription"=>"Number of participants who developed Acute Graft vs Host Disease (GVHD) Grades I, II, III, IV as defined by CIMBTR criteria for Organ Stages of Acute GVHD.\n\nGrades are defined as:\n\nGrade I: Skin = Maculopapular rash< 25% of body surface area (BSA); Liver = Total Bilirubin 2-3 mg/dL; Lower GI = stool output/day is 500-999 mL/day.\n\nGrade II: Skin = rash on 25-50 percent body surface area; Liver = Total Bilirubin 3.1-6.0 mg/dL; Lower GI = Diarrhea 1001-1500 mL/day.\n\nGrade III: Skin = Rash on >50% of body surface; Liver = Total Bilirubin 6.1 - 15.0 mg/dL; Lower GI = Diarrhea > 1500 mL/day.\n\nGrade IV: Skin = Generalized erythroderma plus bullous formation; Liver = Total Bilirubin >15 mg/dL; Lower GI = Severe abdominal pain with or without ileus.\n\nGrade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening."}, {"SecondaryOutcomeMeasure"=>"Number of Participants Who Developed Chronic GVHD", "SecondaryOutcomeTimeFrame"=>"Day 100 to year 2", "SecondaryOutcomeDescription"=>"Number of participants who developed Chronic Graft vs Host Disease (GVHD).\n\nChronic GVHD is defined as symptoms that persist or appear after 100 days since the time of stem cell transplantation."}]}}, "OversightModule"=>{"IsFDARegulatedDrug"=>"Yes", "IsFDARegulatedDevice"=>"No"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Engraftment", "Peripheral Blood Stem Cells", "Non-Myeloablative Bone Marrow Transplantation", "Metastatic Solid Tumors", "Graft-Versus-Host Disease", "Cancer", "Tumor"]}, "ConditionList"=>{"Condition"=>["Neoplasm Metastasis"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"8695872", "ReferenceType"=>"background", "ReferenceCitation"=>"Eibl B, Schwaighofer H, Nachbaur D, Marth C, Gachter A, Knapp R, Bock G, Gassner C, Schiller L, Petersen F, Niederwieser D. Evidence for a graft-versus-tumor effect in a patient treated with marrow ablative chemotherapy and allogeneic bone marrow transplantation for breast cancer. Blood. 1996 Aug 15;88(4):1501-8."}, {"ReferencePMID"=>"9557210", "ReferenceType"=>"background", "ReferenceCitation"=>"Or R, Ackerstein A, Nagler A, Kapelushnik J, Naparstek E, Samuel S, Amar A, Bruatbar C, Slavin S. Allogeneic cell-mediated immunotherapy for breast cancer after autologous stem cell transplantation: a clinical pilot study. Cytokines Cell Mol Ther. 1998 Mar;4(1):1-6."}, {"ReferencePMID"=>"9508181", "ReferenceType"=>"background", "ReferenceCitation"=>"Ueno NT, Rondon G, Mirza NQ, Geisler DK, Anderlini P, Giralt SA, Andersson BS, Claxton DF, Gajewski JL, Khouri IF, Korbling M, Mehra RC, Przepiorka D, Rahman Z, Samuels BI, van Besien K, Hortobagyi GN, Champlin RE. Allogeneic peripheral-blood progenitor-cell transplantation for poor-risk patients with metastatic breast cancer. J Clin Oncol. 1998 Mar;16(3):986-93. doi: 10.1200/JCO.1998.16.3.986."}]}, "SeeAlsoLinkList"=>{"SeeAlsoLink"=>[{"SeeAlsoLinkURL"=>"https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_1999-H-0064.html", "SeeAlsoLinkLabel"=>"NIH Clinical Center Detailed Web Page"}]}}, "DescriptionModule"=>{"BriefSummary"=>"The goal of this research study is to identify other types of cancer (malignant neoplasms) that may be treatable with stem cell transplantation (allogenic peripheral blood stem cell transplantation.\n\nPatients with a variety of different types of cancerous tumors that have spread (metastasized) and whose conditions have not improved with stand therapy, will be eligible to participate. Those patients selected to participate in the study will undergo a procedure known as a \"mini-transplant\". The mini-transplant is a transplantation of stem-cells collected from a sibling (brother or sister) of the patient. Unlike traditional bone marrow transplants, the mini-transplant does not require intense chemotherapy or radiation therapy. Because of this, patients experience fewer and less severe side effects.\n\nThis study is open to patients diagnosed with a variety of metastatic solid tumors including esophageal, gastric (stomach), colon, rectal, liver tumors (hepatoma), cancer of the biliary system (cholangiocarcinoma), cancer of the pancreas, lung, breast, prostate, bone (sarcoma), adrenal basal cell, bladder, and adenocarcinomas of unk primary origin.", "DetailedDescription"=>"The main objective of this study is to identify metastatic neoplasms, which may be susceptible to the GVT effect. We will treat patients with progressive metastatic solid tumors refractory to standard therapy with a non-myeloablative allogeneic PBSC transplant from a family donor. A GVT effect from immunocompetent donor immune cells could extend life expectancy and possibly cure such patients.\n\nEligible patients will be treated with an allogeneic peripheral blood stem cell transplant from an HLA identical or single HLA antigen-mismatched family donor, using an intensive immunosuppressive regimen without myeloablation (\"mini-transplant\") in an attempt to decrease the transplant related toxicities while preserving the anti-malignancy and/or anti-host marrow effect of the graft. The low intensity non-myeloablative conditioning regimen should provide adequate immunosuppression to allow stem cell and lymphocyte engraftment. A T-cell replete, donor-derived, granulocyte colony stimulating factor (G-CSF)-mobilized peripheral blood stem cells (PBSC) will be used to establish hematopoietic and lymphoid reconstitution. We will infuse lymphocytes in patients with <100% donor T-cell chimerism or with evidence of tumor progression in an attempt to prevent graft rejection and enhance a graft-versus-malignancy effect, respectively.\n\nThis trial is open to several different types of metastatic, treatment-refractory, solid neoplasms, breast, cholangiocarcinoma, small intestine/colon/rectal adenocarcinoma, esophageal/gastric, hepatocellular, pancreatic, prostate, and bony/soft tissue sarcomas. The trial design permits up to 10 patients with a specific tumor type to be enrolled to screen for anti-tumor effects. A single complete response in a specific tumor type is an indication to exclude further patients with that diagnosis from the study. Subsequently, a new protocol which focuses on further defining a GVT effect in that disease category will be instituted."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"80 years", "MinimumAge"=>"10 years", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"INCLUSION CRITERIA:\n\nPATIENTS:\n\nPatients with metastatic solid tumors ( breast, cholangiocarcinoma, small intestine/colon/rectal, adenocarcinoma, esophageal/gastric, hepatocellular, pancreatic, prostate, bony/soft tissue sarcomas, which are histologically confirmed, progressive and incurable.\n\nDue to low accrual, effective 12/19/2006, patients with adrenal, basal cell, transitional cell carcinoma of the bladder or uroepithelium, ovarian, small cell lung cancer, non small cell lung cancer, and adenocarcinomas of unknown primary origin are no longer eligible for the trial.\n\nAge greater than or equal to 10 to less than or equal to 80.\n\nNo known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy.\n\nMetastatic disease, which is bi-dimensionally evaluable radiographically.\n\nNo prior treatment for neoplasm within 30 days.\n\nAbility to comprehend the investigational nature of the study and provide informed consent.\n\nAvailability of HLA identical or single HLA-locus mismatched family donor.\n\nWillingness and availability to return to the NIH for scheduled follow-ups.\n\nDONOR:\n\nHLA identical or single HLA-locus mismatched family donor\n\nAge greater than or equal to 10 up to 80 years old.\n\nAbility to comprehend the investigational nature of the study and provide informed consent.\n\nEXCLUSION CRITERIA:\n\nPATIENT:\n\nPregnant or lactating.\n\nAge less than 10 or greater than 80 years.\n\nECOG performance status of 3 or more.\n\nPsychiatric disorder or mental deficiency severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.\n\nMajor anticipated illness or organ failure incompatible with survival from PBSC transplant.\n\nDLCO: less than 40% predicted.\n\nLeft ventricular ejection fraction: less than 30%.\n\nSerum creatinine greater than 2.5mg/dl or creatinine clearance less than 50 cc/min by 24 hr urine collection.\n\nSerum bilirubin greater than 4 mg/dl\n\nTransaminases greater than 5 times the upper limit of normal.\n\nOral intake less than 1,200 calories/day.\n\nRecent weight loss of greater than or equal to 10% of actual body weight.\n\nLife expectancy less than 3 months\n\nTherapy for malignancy within 4 weeks of beginning protocol.\n\nCNS metastatic disease associated with intracranial bleeding, uncontrolled seizure disorder or significant intracranial mass effect.\n\nOther malignant diseases liable to relapse or progress within 5 years.\n\nUncontrolled infection.\n\nDONOR:\n\nPregnant or lactating.\n\nDonor unfit to receive G-CSF and undergo apheresis. (Uncontrolled hypertension, history of congestive heart failure or unstable angina, thrombocytopenia).\n\nAge less than 10 or greater than 80 years.\n\nHIV positive. Donors who are positive for HBV, HCV or HTLV-I may be used at the discretion of the investigator following counseling and approval from the recipient."}, "IdentificationModule"=>{"NCTId"=>"NCT00001880", "BriefTitle"=>"Stem Cell Transplantation for Metastatic Solid Tumors", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Exploratory Study of Non-Myeloablative Allogeneic Stem Cell Transplantation and Donor Lymphocyte Infusions for Metastatic Neoplasms Refractory to Standard Therapy", "NCTIdAliasList"=>{"NCTIdAlias"=>["NCT00003839"]}, "OrgStudyIdInfo"=>{"OrgStudyId"=>"990064"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"99-H-0064"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors", "ArmGroupDescription"=>"Cyclosporin beginning day -4 then stem cells given on Day 0 followed by intravenous Methotrexate on days +1, +3, and +6.", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: methotrexate", "Drug: Cyclosporin"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"methotrexate", "InterventionType"=>"Drug", "InterventionDescription"=>"Cyclosporin beginning day -4 and intravenous Methotrexate on days +1, +3, and +6 will be given", "InterventionOtherNameList"=>{"InterventionOtherName"=>["MTX (methotrexate)"]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors"]}}, {"InterventionName"=>"Cyclosporin", "InterventionType"=>"Drug", "InterventionDescription"=>"Cyclosporin beginning day -4 and intravenous Methotrexate on days +1, +3, and +6 will be given", "InterventionOtherNameList"=>{"InterventionOtherName"=>["CsA (Cyclosporin)"]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Institutes of Health Clinical Center, 9000 Rockville Pike"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Richard W Childs, M.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"National Heart, Lung, and Blood Institute (NHLBI)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Heart, Lung, and Blood Institute (NHLBI)", "LeadSponsorClass"=>"NIH"}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
