{"eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"1/Phase I:\n\nDrug: Fludarabine\n\nDays -5 to Day -1: Fludarabine 25 mg/m\\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.\n\nOther Names: •Fludara\n\nBiological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)\n\nDay 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.\n\nDrug: Cyclophosphamide\n\nDays -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.\n\nOther Names: •Cytoxan\n\nDrug: Aldesleukin\n\nAldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).\n\nOther Names: •Proleukin","id":"EG000","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":1,"seriousNumAtRisk":3,"title":"Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"1/Phase I:\n\nDrug: Fludarabine\n\nDays -5 to Day -1: Fludarabine 25 mg/m\\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.\n\nOther Names: •Fludara\n\nBiological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)\n\nDay 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.\n\nDrug: Cyclophosphamide\n\nDays -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.\n\nOther Names: •Cytoxan\n\nDrug: Aldesleukin\n\nAldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).\n\nOther Names: •Proleukin","id":"EG001","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":2,"seriousNumAtRisk":3,"title":"Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"1/Phase I:\n\nDrug: Fludarabine\n\nDays -5 to Day -1: Fludarabine 25 mg/m\\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.\n\nOther Names: •Fludara\n\nBiological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)\n\nDay 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.\n\nDrug: Cyclophosphamide\n\nDays -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.\n\nOther Names: •Cytoxan\n\nDrug: Aldesleukin\n\nAldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).\n\nOther Names: •Proleukin","id":"EG002","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"title":"Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"1/Phase I:\n\nDrug: Fludarabine\n\nDays -5 to Day -1: Fludarabine 25 mg/m\\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.\n\nOther Names: •Fludara\n\nBiological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)\n\nDay 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.\n\nDrug: Cyclophosphamide\n\nDays -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.\n\nOther Names: •Cytoxan\n\nDrug: Aldesleukin\n\nAldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).\n\nOther Names: •Proleukin","id":"EG003","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":1,"seriousNumAtRisk":3,"title":"Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2"},{"deathsNumAffected":1,"deathsNumAtRisk":3,"description":"1/Phase I:\n\nDrug: Fludarabine\n\nDays -5 to Day -1: Fludarabine 25 mg/m\\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.\n\nOther Names: •Fludara\n\nBiological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)\n\nDay 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.\n\nDrug: Cyclophosphamide\n\nDays -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.\n\nOther Names: •Cytoxan\n\nDrug: Aldesleukin\n\nAldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).\n\nOther Names: •Proleukin","id":"EG004","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":2,"seriousNumAtRisk":3,"title":"Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Pain: Abdomen NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Fatigue (asthenia, lethargy, malaise)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Infection with unknown ANC: Nerve-peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG002","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Albumin (hypoalbuminemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Psychosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":3,"numEvents":2}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Supraventricular and nodal arrhythmia: Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG002","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG004","numAffected":3,"numAtRisk":3,"numEvents":3}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG002","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG003","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG004","numAffected":3,"numAtRisk":3,"numEvents":3}],"term":"Neutrophils/granulocytes (ANC/AGC) count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG004","numAffected":3,"numAtRisk":3,"numEvents":3}],"term":"Platelets"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Thrombosis/embolism (vascular access related)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Sodium, serum-low (hyponatremia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Bilirubin (hyperbilirubinemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"AST, SGOT (serum glutamic oxaloacetic transaminase)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Magnesium, serum-high (hypermagnesemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"PTT (Partial Thromboplastin Time)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"TRALI"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Phosphate, serum-low"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Lymphocyte count decreased"}],"timeFrame":"Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05."}