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CAR T Cell Receptor Immunotherapy Targeting EGFRvIII for Patients With Malignant Gliomas Expressing EGFRvIII

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01454596
Recruitment Status : Completed
First Posted : October 19, 2011
Results First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Steven Rosenberg, M.D., National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Malignant Glioma
Glioblastoma
Brain Cancer
Gliosarcoma
Interventions Biological: Epidermal growth factor receptor(EGFRv)III Chimeric antigen receptor (CAR) transduced PBL
Drug: Aldesleukin
Drug: Fludarabine
Drug: Cyclophosphamide
Enrollment 18
Recruitment Details  
Pre-assignment Details All patients were treated on the Ph I portion of the study. After encountering a patient mortality at dose level 8 and a grade 3 pulmonary toxicity at dose level 9 without seeing any clinical responses, the principal investigator and senior staff re-evaluated the protocol and elected to close the protocol rather than proceed into the Ph II portion.
Arm/Group Title Group A (Steroids) - Cohort 1: 1x10(7) Group A (Steroids) - Cohort 2: 3x10(7) Group A (Steroids) - Cohort 3: 1x10(8) Group B (No Steroids) - Cohort 1: 1x10(7) Group B (No Steroids) - Cohort 2: 3x10(7) Group B (No Steroids) - Cohort 3: 1x10(8) Group B (No Steroids) - Cohort 4: 3x10(8) Group B (No Steroids) - Cohort 5: 1x10(9) Combined Steroids/no Steroids) - Cohort 6: 3x10(9) Combined Steroids/no Steroids) - Cohort 7: 1x10(10) Combined Steroids/no Steroids) - Cohort 8: 3-6x10(10) Combined Steroids/no Steroids) - Cohort 9: 3x10(10)
Hide Arm/Group Description

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated.

Day 0: Cells will be infused intravenously over 20-30 minutes. Given as a split dose, 2 hours apart.

Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Period Title: Overall Study
Started 1 1 1 1 1 1 1 3 3 3 1 1
Completed 1 1 1 1 1 1 1 3 3 2 0 1
Not Completed 0 0 0 0 0 0 0 0 0 1 1 0
Reason Not Completed
Death             0             0             0             0             0             0             0             0             0             1             1             0
Arm/Group Title Group A (Steroids) - Cohort 1: 1x10(7) Group A (Steroids) - Cohort 2: 3x10(7) Group A (Steroids) - Cohort 3: 1x10(8) Group B (No Steroids) - Cohort 1: 1x10(7) Group B (No Steroids) - Cohort 2: 3x10(7) Group B (No Steroids) - Cohort 3: 1x10(8) Group B (No Steroids) - Cohort 4: 3x10(8) Group B (No Steroids) - Cohort 5: 1x10(9) Combined Steroids/no Steroids) - Cohort 6: 3x10(9) Combined Steroids/no Steroids) - Cohort 7: 1x10(10) Combined Steroids/no Steroids) - Cohort 8: 3-6x10(10) Combined Steroids/no Steroids) - Cohort 9: 3x10(10) Total
Hide Arm/Group Description

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Given as a split dose, 2 hours apart.

Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Total of all reporting groups
Overall Number of Baseline Participants 1 1 1 1 1 1 1 3 3 3 1 1 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 3 participants 3 participants 3 participants 1 participants 1 participants 18 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
3
 100.0%
2
  66.7%
3
 100.0%
1
 100.0%
1
 100.0%
17
  94.4%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 3 participants 3 participants 3 participants 1 participants 1 participants 18 participants
45.0 43.0 52.0 46.0 57.0 56.0 53.0 55.3  (0.6) 62.3  (3.2) 56.0  (11.4) 47.0 57.0 54.3  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 3 participants 3 participants 3 participants 1 participants 1 participants 18 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
1
  33.3%
1
  33.3%
0
   0.0%
0
   0.0%
3
  16.7%
Male
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
2
  66.7%
2
  66.7%
2
  66.7%
1
 100.0%
1
 100.0%
15
  83.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 3 participants 3 participants 3 participants 1 participants 1 participants 18 participants
Hispanic or Latino
0
   0.0%
1
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.6%
Not Hispanic or Latino
1
 100.0%
0
   0.0%
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
1
 100.0%
1
 100.0%
17
  94.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 3 participants 3 participants 3 participants 1 participants 1 participants 18 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
 100.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  11.1%
White
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
0
   0.0%
2
  66.7%
3
 100.0%
3
 100.0%
1
 100.0%
1
 100.0%
16
  88.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 3 participants 3 participants 3 participants 1 participants 1 participants 18 participants
1 1 1 1 1 1 1 3 3 3 1 1 18
Prior Treatment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 3 participants 3 participants 3 participants 1 participants 1 participants 18 participants
Surgery, radiation, temozolomide, bevacizumab,BCNU
1
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.6%
Surgery, radiation, temozolomide, bevacizumab
0
   0.0%
1
 100.0%
0
   0.0%
1
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
  16.7%
Surgery, radiation, temozolomide
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
 100.0%
1
 100.0%
1
 100.0%
1
  33.3%
1
  33.3%
0
   0.0%
0
   0.0%
1
 100.0%
6
  33.3%
Radiation, temozolomide, bevacizumab
0
   0.0%
0
   0.0%
1
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.6%
Surgery,radiation,temozolomide,bevacizumab,AZD7451
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.6%
Surgery, radiation, temozolomide, veliparib, beva
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.6%
Surg,rad,temozolomide,bevacizumab,EGFRvIII vaccine
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.6%
Surgery, radiation, temozolomide, IMA950 vaccine
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
1
   5.6%
Surg,rad,temoz,EGFRvIIIvacc.vs.placebo tr,bev,treb
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
1
   5.6%
Surgery, radiation, temozolomide, carotuximab,beva
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
1
   5.6%
Surg,rad,temoz,EGFRvIIIvacc.vs.placebo trial,beva
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
 100.0%
0
   0.0%
1
   5.6%
[1]
Measure Description: Procedures/Chemotherapy/Vaccines: Surgery = surg; Radiation = rad; Bevacizumab = beva; Temozolomide = temoz; BCNU = Carmustine; AZD7451 = AZ12607092; EGFRvIII = epidermal growth factor receptor variant III; Vaccine = vacc; Trial = tr; Trebananib = treb; and IMA950 is a vaccine.
1.Primary Outcome
Title Number of Treatment Related Adverse Events
Hide Description Aggregate of all adverse events ≥Grade 3 that are possibly, probably, and definitely related to treatment. Adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). Per CTCAE, Grade 3 adverse events are severe, Grade 4 is life threatening, and Grade 5 is death.
Time Frame From 4 weeks after cell infusion up to 77 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A (Steroids) - Cohort 1: 1x10(7) Group A (Steroids) - Cohort 2: 3x10(7) Group A (Steroids) - Cohort 3: 1x10(8) Group B (No Steroids) - Cohort 1: 1x10(7) Group B (No Steroids) - Cohort 2: 3x10(7) Group B (No Steroids) - Cohort 3: 1x10(8) Group B (No Steroids) - Cohort 4: 3x10(8) Group B (No Steroids) - Cohort 5: 1x10(9) Combined Steroids/no Steroids) - Cohort 6: 3x10(9) Combined Steroids/no Steroids) - Cohort 7: 1x10(10) Combined Steroids/no Steroids) - Cohort 8: 3-6x10(10) Combined Steroids/no Steroids) - Cohort 9: 3x10(10)
Hide Arm/Group Description:

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Given as a split dose, 2 hours apart.

Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Overall Number of Participants Analyzed 1 1 1 1 1 1 1 3 3 3 1 1
Measure Type: Number
Unit of Measure: adverse events
0 0 0 0 0 0 0 0 0 0 1 1
2.Primary Outcome
Title Progression Free Survival
Hide Description Progression was assessed by the Response Assessment in Neuro-Oncology (RANO) criteria and is defined as the circumstance when the magnetic resonance imaging (MRI) scan is ranked -2 (definitely worse) or -3 (development of a new lesion).
Time Frame Time from the date of registration to the date of first observation of progressive disease up to 6 months after end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Combined steroids/no steroids, Cohort 8: participant experienced a treatment-related mortality (TRM).
Arm/Group Title Group A (Steroids) - Cohort 1: 1x10(7) Group A (Steroids) - Cohort 2: 3x10(7) Group A (Steroids) - Cohort 3: 1x10(8) Group B (No Steroids) - Cohort 1: 1x10(7) Group B (No Steroids) - Cohort 2: 3x10(7) Group B (No Steroids) - Cohort 3: 1x10(8) Group B (No Steroids) - Cohort 4: 3x10(8) Group B (No Steroids) - Cohort 5: 1x10(9) Combined Steroids/no Steroids) - Cohort 6: 3x10(9) Combined Steroids/no Steroids) - Cohort 7: 1x10(10) Combined Steroids/no Steroids) - Cohort 8: 3-6x10(10) Combined Steroids/no Steroids) - Cohort 9: 3x10(10)
Hide Arm/Group Description:

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Given as a split dose, 2 hours apart.

Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Overall Number of Participants Analyzed 1 1 1 1 1 1 1 3 3 3 1 1
Median (Inter-Quartile Range)
Unit of Measure: months
1.1 1.1 1.3 1.9 2.0 1.5 1.2
1.1
(0.9 to 1.3)
2.7
(0.9 to 12.5)
1.1
(1.1 to 1.6)
0 2.0
3.Secondary Outcome
Title Number of Patients With an Objective Response
Hide Description Objective response was assessed by comparison with baseline dynamic contrast enhanced magnetic resonance imaging with perfusion using Neuro-oncology Working Group proposed guidelines. Complete Response is disappearance of all measurable and non-measurable disease for at least 4 weeks. Partial Response is >/= 50% decrease in lesions for at least 4 weeks. Stable Disease does not meet the criteria for complete response, partial response or progression and requires stable lesions compared with baseline. Progression is >/= 25% increase in lesions.
Time Frame 4 weeks after cell infusion and monthly as feasible up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A (Steroids) - Cohort 1: 1x10(7) Group A (Steroids) - Cohort 2: 3x10(7) Group A (Steroids) - Cohort 3: 1x10(8) Group B (No Steroids) - Cohort 1: 1x10(7) Group B (No Steroids) - Cohort 2: 3x10(7) Group B (No Steroids) - Cohort 3: 1x10(8) Group B (No Steroids) - Cohort 4: 3x10(8) Group B (No Steroids) - Cohort 5: 1x10(9) Combined Steroids/no Steroids) - Cohort 6: 3x10(9) Combined Steroids/no Steroids) - Cohort 7: 1x10(10) Combined Steroids/no Steroids) - Cohort 8: 3-6x10(10) Combined Steroids/no Steroids) - Cohort 9: 3x10(10)
Hide Arm/Group Description:

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Given as a split dose, 2 hours apart.

Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Overall Number of Participants Analyzed 1 1 1 1 1 1 1 3 3 3 1 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Circulating Chimeric Antigen Receptor (CAR+) Cells in Peripheral Blood at 1 Month Post Treatment
Hide Description CAR and vector presence were quantitated in peripheral blood mononuclear cell (PBMC) samples using established polymerase chain reaction (PCR) techniques
Time Frame 1 month post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Only 1/3 participants were evaluable in cohort 6 at one month, and 2/3 participants were evaluable in cohort 7 at one month. Due to a low number of events, nonspecific binding of anti-human Fab’, and slow recovery of the lymphocyte compartment, the data reported should be interpreted with caution.
Arm/Group Title Group A (Steroids) - Cohort 1: 1x10(7) Group A (Steroids) - Cohort 2: 3x10(7) Group A (Steroids) - Cohort 3: 1x10(8) Group B (No Steroids) - Cohort 1: 1x10(7) Group B (No Steroids) - Cohort 2: 3x10(7) Group B (No Steroids) - Cohort 3: 1x10(8) Group B (No Steroids) - Cohort 4: 3x10(8) Group B (No Steroids) - Cohort 5: 1x10(9) Combined Steroids/no Steroids) - Cohort 6: 3x10(9) Combined Steroids/no Steroids) - Cohort 7: 1x10(10) Combined Steroids/no Steroids) - Cohort 8: 3-6x10(10) Combined Steroids/no Steroids) - Cohort 9: 3x10(10)
Hide Arm/Group Description:

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Given as a split dose, 2 hours apart.

Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Overall Number of Participants Analyzed 1 1 1 1 1 1 1 3 1 2 1 1
Median (Full Range)
Unit of Measure: K/µL
23
(23 to 23)
70
(70 to 70)
36
(36 to 36)
67
(67 to 67)
7
(7 to 7)
43
(43 to 43)
28
(28 to 28)
25
(10 to 219)
12
(12 to 12)
67.5
(26 to 109)
NA [1] 
(NA to NA)
8
(8 to 8)
[1]
Patient death-data unavailable
5.Secondary Outcome
Title Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Hide Description Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame 51 dys Grp A, Cohort 1; Cohort 2:68 dys; Cohort 3:40 dys; Grp B, Cohort 1:67 dys; Cohort 2:48 dys; Cohort 3:55 dys; Cohort 4: 46 dys; Cohort 5:147 dys; C. Ster/No Ster Grp, Cohort 6:12 mos, 26 dys; Cohort 7:11 mos, 18 dys; Cohort 8:7 dys; Cohort 9:70 dys.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A (Steroids) - Cohort 1: 1x10(7) Group A (Steroids) - Cohort 2: 3x10(7) Group A (Steroids) - Cohort 3: 1x10(8) Group B (No Steroids) - Cohort 1: 1x10(7) Group B (No Steroids) - Cohort 2: 3x10(7) Group B (No Steroids) - Cohort 3: 1x10(8) Group B (No Steroids) - Cohort 4: 3x10(8) Group B (No Steroids) - Cohort 5: 1x10(9) Combined Steroids/no Steroids) - Cohort 6: 3x10(9) Combined Steroids/no Steroids) - Cohort 7: 1x10(10) Combined Steroids/no Steroids) - Cohort 8: 3-6x10(10) Combined Steroids/no Steroids) - Cohort 9: 3x10(10)
Hide Arm/Group Description:

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Given as a split dose, 2 hours apart.

Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Overall Number of Participants Analyzed 1 1 1 1 1 1 1 3 3 3 1 1
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
1
 100.0%
1
 100.0%
Time Frame Date treatment consent signed to date off study, approximately 51 days for Group A, Cohort 1; Cohort 2: 68 days; Cohort 3: 40 days; Group B, Cohort 1: 67 days; Cohort 2: 48 days; Cohort 3: 55 days; Cohort 4: 46 days; Cohort 5: 147 days; and Combined Steroids/No Steroids Group, Cohort 6: 12 months and 26 days; Cohort 7: 11 months and 18 days; Cohort 8: 7 days; Cohort 9: 70 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A (Steroids) - Cohort 1: 1x10(7) Group A (Steroids) - Cohort 2: 3x10(7) Group A (Steroids) - Cohort 3: 1x10(8) Group B (No Steroids) - Cohort 1: 1x10(7) Group B (No Steroids) - Cohort 2: 3x10(7) Group B (No Steroids) - Cohort 3: 1x10(8) Group B (No Steroids) - Cohort 4: 3x10(8) Group B (No Steroids) - Cohort 5: 1x10(9) Combined Steroids/no Steroids) - Cohort 6: 3x10(9) Combined Steroids/no Steroids) - Cohort 7: 1x10(10) Combined Steroids/no Steroids) - Cohort 8: 3-6x10(10) Combined Steroids/no Steroids) - Cohort 9: 3x10(10)
Hide Arm/Group Description

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

After Amendment H, steroid and no steroid groups were no longer separated. Day 0: Cells will be infused intravenously over 20-30 minutes. Given as a split dose, 2 hours apart.

Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg 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 15 doses).

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

All-Cause Mortality
Group A (Steroids) - Cohort 1: 1x10(7) Group A (Steroids) - Cohort 2: 3x10(7) Group A (Steroids) - Cohort 3: 1x10(8) Group B (No Steroids) - Cohort 1: 1x10(7) Group B (No Steroids) - Cohort 2: 3x10(7) Group B (No Steroids) - Cohort 3: 1x10(8) Group B (No Steroids) - Cohort 4: 3x10(8) Group B (No Steroids) - Cohort 5: 1x10(9) Combined Steroids/no Steroids) - Cohort 6: 3x10(9) Combined Steroids/no Steroids) - Cohort 7: 1x10(10) Combined Steroids/no Steroids) - Cohort 8: 3-6x10(10) Combined Steroids/no Steroids) - Cohort 9: 3x10(10)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)      0/1 (0.00%)      0/1 (0.00%)      0/1 (0.00%)      0/1 (0.00%)      0/1 (0.00%)      0/1 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      1/1 (100.00%)      0/1 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Group A (Steroids) - Cohort 1: 1x10(7) Group A (Steroids) - Cohort 2: 3x10(7) Group A (Steroids) - Cohort 3: 1x10(8) Group B (No Steroids) - Cohort 1: 1x10(7) Group B (No Steroids) - Cohort 2: 3x10(7) Group B (No Steroids) - Cohort 3: 1x10(8) Group B (No Steroids) - Cohort 4: 3x10(8) Group B (No Steroids) - Cohort 5: 1x10(9) Combined Steroids/no Steroids) - Cohort 6: 3x10(9) Combined Steroids/no Steroids) - Cohort 7: 1x10(10) Combined Steroids/no Steroids) - Cohort 8: 3-6x10(10) Combined Steroids/no Steroids) - Cohort 9: 3x10(10)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1 (0.00%)      0/1 (0.00%)      0/1 (0.00%)      0/1 (0.00%)      0/1 (0.00%)      0/1 (0.00%)      0/1 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      1/1 (100.00%)      1/1 (100.00%)    
General disorders                         
Death not associated with CTCAE term: Multi-organ failure  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                         
Dyspnea (shortness of breath)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1
Hypoxia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A (Steroids) - Cohort 1: 1x10(7) Group A (Steroids) - Cohort 2: 3x10(7) Group A (Steroids) - Cohort 3: 1x10(8) Group B (No Steroids) - Cohort 1: 1x10(7) Group B (No Steroids) - Cohort 2: 3x10(7) Group B (No Steroids) - Cohort 3: 1x10(8) Group B (No Steroids) - Cohort 4: 3x10(8) Group B (No Steroids) - Cohort 5: 1x10(9) Combined Steroids/no Steroids) - Cohort 6: 3x10(9) Combined Steroids/no Steroids) - Cohort 7: 1x10(10) Combined Steroids/no Steroids) - Cohort 8: 3-6x10(10) Combined Steroids/no Steroids) - Cohort 9: 3x10(10)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      1/1 (100.00%)      1/1 (100.00%)      1/1 (100.00%)      1/1 (100.00%)      1/1 (100.00%)      1/1 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      1/1 (100.00%)      1/1 (100.00%)    
Blood and lymphatic system disorders                         
Febrile Neutropenia  1 [1]  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0
Cardiac disorders                         
Supraventricular and nodal arrhythmia::Atrial fibrillation  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1
Gastrointestinal disorders                         
Diarrhea  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
General disorders                         
Fatigue (asthenia, lethargy, malaise)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 1/3 (33.33%)  1 1/3 (33.33%)  1 1/3 (33.33%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0
Infections and infestations                         
Infection  1 [2]  1/1 (100.00%)  1 0/1 (0.00%)  0 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 0/1 (0.00%)  0 2/3 (66.67%)  2 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0
Investigations                         
PTT (Partial Thromboplastin Time)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Platelets  1  1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 3/3 (100.00%)  3 3/3 (100.00%)  3 3/3 (100.00%)  3 1/1 (100.00%)  1 1/1 (100.00%)  1
Leukocytes (total WBC)  1  1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 3/3 (100.00%)  3 3/3 (100.00%)  3 3/3 (100.00%)  3 0/1 (0.00%)  0 0/1 (0.00%)  0
Lymphopenia  1  1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  2 1/1 (100.00%)  1 3/3 (100.00%)  3 3/3 (100.00%)  3 3/3 (100.00%)  3 1/1 (100.00%)  1 1/1 (100.00%)  1
Neutrophils/granulocytes (ANC/AGC)  1  1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 3/3 (100.00%)  3 3/3 (100.00%)  3 3/3 (100.00%)  3 1/1 (100.00%)  1 1/1 (100.00%)  1
ALT, SGPT (serum glutamic pyruvic transaminase)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
AST, SGOT(serum glutamic oxaloacetic transaminase)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Creatinine  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Hemoglobin  1  1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 2/3 (66.67%)  2 2/3 (66.67%)  2 0/1 (0.00%)  0 0/1 (0.00%)  0
Metabolism and nutrition disorders                         
Potassium, serum-high (hyperkalemia)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Potassium, serum-low (hypokalemia)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Phosphate, serum-low (hypophosphatemia)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 1/1 (100.00%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0
Sodium, serum-low (hyponatremia)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Nervous system disorders                         
Dizziness  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Pain::Head/headache  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Neuropathy: motor  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0
Psychiatric disorders                         
Confusion  1  1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 1/1 (100.00%)  1 0/1 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Renal and urinary disorders                         
Incontinence, urinary  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                         
Pulmonary/Upper Respiratory - Other (pulmonary edema)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1
Vascular disorders                         
Thrombosis/thrombus/embolism  1  1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Acute vascular leak syndrome  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0
Hypotension  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
(fever of unknown origin without clinically or microbiologically documented infection)(ANC <1.0 x 10e9/L, fever >=38.5 degrees C)
[2]
(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)::Blood
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Dr. Steven A. Rosenberg
Organization: National Cancer Institute
Phone: 240-858-3080
EMail: sar@nci.nih.gov
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Responsible Party: Steven Rosenberg, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01454596     History of Changes
Other Study ID Numbers: 110266
11-C-0266
First Submitted: October 6, 2011
First Posted: October 19, 2011
Results First Submitted: July 8, 2019
Results First Posted: August 21, 2019
Last Update Posted: August 21, 2019