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CAR T Cell Receptor Immunotherapy Targeting VEGFR2 for Patients With Metastatic Cancer

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: NCT01218867
Recruitment Status : Terminated (No objective responses were observed.)
First Posted : October 11, 2010
Results First Posted : July 22, 2016
Last Update Posted : December 10, 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: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Metastatic Cancer
Metastatic Melanoma
Renal Cancer
Interventions Biological: Anti-VEGFR2 CAR CD8 plus PBL
Drug: Cyclophosphamide
Biological: Aldesleukin
Drug: Fludarabine
Enrollment 24
Recruitment Details  
Pre-assignment Details Twenty-four participants were enrolled but one participant was not treated due to a new cancer diagnosis which made the participant ineligible for this protocol.
Arm/Group Title Cohort 1 - 1 x 10(6) Cells (High Dose IL-2) Cohort 2 - 3 x 10(6) Cells (High Dose IL-2) Cohort 3 - 1 x 10(7) Cells (High Dose IL-2) Cohort 4 - 3 x 10(7) Cells (High Dose IL-2) Cohort 5 - 1 x 10(8) Cells (High Dose IL-2) Cohort 6 - 3 x 10(8) Cells (High Dose IL-2) Cohort 7 - 1 x 10(9) Cells (High Dose IL-2) Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2) Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2) Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2) Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)
Hide Arm/Group Description

Anti-vascular endothelial growth factor receptor 2 (VEGFR2) chimeric T cell receptor (CAR) cluster of differentiation 8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Period Title: Overall Study
Started 1 1 3 1 1 1 4 3 3 4 2
Completed 1 1 3 1 1 1 3 3 3 4 2
Not Completed 0 0 0 0 0 0 1 0 0 0 0
Reason Not Completed
Death during treatment             0             0             0             0             0             0             1             0             0             0             0
Arm/Group Title Cohort 1 - 1 x 10(6) Cells (High Dose IL-2) Cohort 2 - 3 x 10(6) Cells (High Dose IL-2) Cohort 3 - 1 x 10(7) Cells (High Dose IL-2) Cohort 4 - 3 x 10(7) Cells (High Dose IL-2) Cohort 5 - 1 x 10(8) Cells (High Dose IL-2) Cohort 6 - 3 x 10(8) Cells (High Dose IL-2) Cohort 7 - 1 x 10(9) Cells (High Dose IL-2) Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2) Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2) Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2) Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2) Total
Hide Arm/Group Description

Anti-vascular endothelial growth factor receptor 2 (VEGFR2) Chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Total of all reporting groups
Overall Number of Baseline Participants 1 1 3 1 1 1 4 3 3 4 2 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 3 participants 1 participants 1 participants 1 participants 4 participants 3 participants 3 participants 4 participants 2 participants 24 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%
Between 18 and 65 years
1
 100.0%
1
 100.0%
3
 100.0%
0
   0.0%
1
 100.0%
1
 100.0%
4
 100.0%
3
 100.0%
3
 100.0%
4
 100.0%
2
 100.0%
23
  95.8%
>=65 years
0
   0.0%
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%
1
   4.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 1 participants 3 participants 1 participants 1 participants 1 participants 4 participants 3 participants 3 participants 4 participants 2 participants 24 participants
61.0  (0) 51.0  (0) 52.7  (12.1) 65.0  (0) 55.0  (0) 35.0  (0) 45.5  (11.3) 37.0  (18.0) 54.7  (11.9) 46.3  (5.6) 41.5  (10.6) 47.9  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 3 participants 1 participants 1 participants 1 participants 4 participants 3 participants 3 participants 4 participants 2 participants 24 participants
Female
0
   0.0%
0
   0.0%
2
  66.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
1
  33.3%
1
  33.3%
2
  50.0%
0
   0.0%
7
  29.2%
Male
1
 100.0%
1
 100.0%
1
  33.3%
1
 100.0%
1
 100.0%
1
 100.0%
3
  75.0%
2
  66.7%
2
  66.7%
2
  50.0%
2
 100.0%
17
  70.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 3 participants 1 participants 1 participants 1 participants 4 participants 3 participants 3 participants 4 participants 2 participants 24 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
 100.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
2
   8.3%
Not Hispanic or Latino
1
 100.0%
1
 100.0%
3
 100.0%
1
 100.0%
1
 100.0%
0
   0.0%
4
 100.0%
3
 100.0%
2
  66.7%
4
 100.0%
2
 100.0%
22
  91.7%
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%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 3 participants 1 participants 1 participants 1 participants 4 participants 3 participants 3 participants 4 participants 2 participants 24 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%
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%
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%
Black or African American
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%
White
1
 100.0%
1
 100.0%
3
 100.0%
1
 100.0%
1
 100.0%
0
   0.0%
3
  75.0%
2
  66.7%
3
 100.0%
4
 100.0%
1
  50.0%
20
  83.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
 100.0%
1
  25.0%
1
  33.3%
0
   0.0%
0
   0.0%
1
  50.0%
4
  16.7%
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%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 1 participants 1 participants 3 participants 1 participants 1 participants 1 participants 4 participants 3 participants 3 participants 4 participants 2 participants 24 participants
1
 100.0%
1
 100.0%
3
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
4
 100.0%
3
 100.0%
3
 100.0%
4
 100.0%
2
 100.0%
24
 100.0%
1.Primary Outcome
Title Number of Participants With a Response to Therapy
Hide Description Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment starts or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 - 1x10(6) Cells (High Dose IL-2) Cohort 2 - 3x10(6) Cells (High Dose IL-2) Cohort 3 - 1x10(7) Cells (High Dose IL-2) Cohort 4 - 3x10(7) Cells (High Dose IL-2) Cohort 5 - 1x10(8) Cells (High Dose IL-2) Cohort 6 - 3x10(8) Cells (High Dose IL-2) Cohort 7 - 1x10(9) Cells (High Dose IL-2) Cohort 8 - 1x10(9) Cells (Low Dose IL-2) Cohort 9 - 3x10(9) Cells (Low Dose IL-2) Cohort 10 - 1x10(10) Cells (Low Dose IL-2) Cohort 11 - 3x10(10) Cells (Low Dose IL-2)
Hide Arm/Group Description:

Anti-vascular endothelial growth factor receptor 2 (VEGFR2) Chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Overall Number of Participants Analyzed 1 1 3 1 1 1 4 3 3 4 2
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response (CR)
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%
Partial Response (PR)
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
  25.0%
0
   0.0%
Progressive Disease (PD)
1
 100.0%
1
 100.0%
3
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
3
  75.0%
3
 100.0%
3
 100.0%
3
  75.0%
2
 100.0%
Stable Disease (SD)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Number of Participants With Serious and Non-Serious Adverse Events
Hide Description Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). 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 Date treatment consent signed to date off study, approximately, 33 months and 25 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 - 1 x 10(6) Cells (High Dose IL-2) Cohort 2 - 3 x 10(6) Cells (High Dose IL-2) Cohort 3 - 1 x 10(7) Cells (High Dose IL-2) Cohort 4 - 3 x 10(7) Cells (High Dose IL-2) Cohort 5 - 1 x 10(8) Cells (High Dose IL-2) Cohort 6 - 3 x 10(8) Cells (High Dose IL-2) Cohort 7 - 1 x 10(9) Cells (High Dose IL-2) Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2) Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2) Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2) Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)
Hide Arm/Group Description:

Anti-vascular endothelial growth factor receptor 2(VEGFR2) chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Overall Number of Participants Analyzed 1 1 3 1 1 1 4 3 3 4 2
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
1
 100.0%
3
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
4
 100.0%
3
 100.0%
3
 100.0%
3
  75.0%
2
 100.0%
3.Secondary Outcome
Title In Vivo Survival of Chimeric T Cell Receptor (CAR) Gene-engineered Cells
Hide Description Immunological monitoring using both tetramer analysis and staining for the T cell receptor (TCR) will be used to augment polymerase chain reaction (PCR)-based analysis. This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells.
Time Frame 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not done due to the lack of a minimum number (e.g. 4) of required durable responses in the participants. A durable response is defined as a complete response, partial response, or stable disease in at least 4 participants.
Arm/Group Title Cohort 1 - 1 x 10(6) Cells (High Dose IL-2) Cohort 2 - 3 x 10(6) Cells (High Dose IL-2) Cohort 3 - 1 x 10(7) Cells (High Dose IL-2) Cohort 4 - 3 x 10(7) Cells (High Dose IL-2) Cohort 5 - 1 x 10(8) Cells (High Dose IL-2) Cohort 6 - 3 x 10(8) Cells (High Dose IL-2) Cohort 7 - 1 x 10(9) Cells (High Dose IL-2) Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2) Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2) Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2) Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)
Hide Arm/Group Description:

Anti-vascular endothelial growth factor receptor 2(VEGFR2) chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Date treatment consent signed to date off study, approximately, 33 months and 25 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1 (1x10(6) Cells (High Dose IL-2) Cohort 2 (3x10(6) Cells (High Dose IL-2) Cohort 3 (1x10(7) Cells (High Dose IL-2) Cohort 4 (3x10(7) Cells (High Dose IL-2) Cohort 5 (1x10(8) Cells (High Dose IL-2) Cohort 6 (1x10(8) Cells (High Dose IL-2) Cohort 7 (1x10(9) Cells (High Dose IL-2) Cohort 8 (1x10(9) Cells (Low Dose IL-2) Cohort 9 (3x10(9) Cells (Low Dose IL-2) Cohort 10 (1x10(10) Cells (Low Dose IL-2) Cohort 11 (3x10(10) Cells (Low Dose IL-2)
Hide Arm/Group Description

Anti-vascular endothelial growth factor receptor 2 (VEGFR2) chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)

Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr

Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)

Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days

All-Cause Mortality
Cohort 1 (1x10(6) Cells (High Dose IL-2) Cohort 2 (3x10(6) Cells (High Dose IL-2) Cohort 3 (1x10(7) Cells (High Dose IL-2) Cohort 4 (3x10(7) Cells (High Dose IL-2) Cohort 5 (1x10(8) Cells (High Dose IL-2) Cohort 6 (1x10(8) Cells (High Dose IL-2) Cohort 7 (1x10(9) Cells (High Dose IL-2) Cohort 8 (1x10(9) Cells (Low Dose IL-2) Cohort 9 (3x10(9) Cells (Low Dose IL-2) Cohort 10 (1x10(10) Cells (Low Dose IL-2) Cohort 11 (3x10(10) Cells (Low Dose IL-2)
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%)      0/3 (0.00%)      0/1 (0.00%)      0/1 (0.00%)      0/1 (0.00%)      1/4 (25.00%)      0/3 (0.00%)      0/3 (0.00%)      0/4 (0.00%)      0/2 (0.00%)    
Hide Serious Adverse Events
Cohort 1 (1x10(6) Cells (High Dose IL-2) Cohort 2 (3x10(6) Cells (High Dose IL-2) Cohort 3 (1x10(7) Cells (High Dose IL-2) Cohort 4 (3x10(7) Cells (High Dose IL-2) Cohort 5 (1x10(8) Cells (High Dose IL-2) Cohort 6 (1x10(8) Cells (High Dose IL-2) Cohort 7 (1x10(9) Cells (High Dose IL-2) Cohort 8 (1x10(9) Cells (Low Dose IL-2) Cohort 9 (3x10(9) Cells (Low Dose IL-2) Cohort 10 (1x10(10) Cells (Low Dose IL-2) Cohort 11 (3x10(10) Cells (Low Dose IL-2)
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%)      1/3 (33.33%)      0/1 (0.00%)      1/1 (100.00%)      0/1 (0.00%)      3/4 (75.00%)      0/3 (0.00%)      0/3 (0.00%)      0/4 (0.00%)      0/2 (0.00%)    
Gastrointestinal disorders                       
Nausea  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Vomiting  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
General disorders                       
Pain  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations                       
Infection  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Metabolism and nutrition disorders                       
ALT, SGPT (serum glutamic pyruvic transaminase)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 2/4 (50.00%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
AST, SGOT (serum glutamic oxaloacetic transaminase)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 2/4 (50.00%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Bilirubin (hyperbilirubinemia)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 2/4 (50.00%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                       
Hypoxia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 2/4 (50.00%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 (1x10(6) Cells (High Dose IL-2) Cohort 2 (3x10(6) Cells (High Dose IL-2) Cohort 3 (1x10(7) Cells (High Dose IL-2) Cohort 4 (3x10(7) Cells (High Dose IL-2) Cohort 5 (1x10(8) Cells (High Dose IL-2) Cohort 6 (1x10(8) Cells (High Dose IL-2) Cohort 7 (1x10(9) Cells (High Dose IL-2) Cohort 8 (1x10(9) Cells (Low Dose IL-2) Cohort 9 (3x10(9) Cells (Low Dose IL-2) Cohort 10 (1x10(10) Cells (Low Dose IL-2) Cohort 11 (3x10(10) Cells (Low Dose IL-2)
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%)      3/3 (100.00%)      1/1 (100.00%)      1/1 (100.00%)      1/1 (100.00%)      4/4 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      3/4 (75.00%)      2/2 (100.00%)    
Blood and lymphatic system disorders                       
Hemoglobin  1  1/1 (100.00%)  1 1/1 (100.00%)  1 1/3 (33.33%)  1 0/1 (0.00%)  0 1/1 (100.00%)  1 1/1 (100.00%)  1 3/4 (75.00%)  3 2/3 (66.67%)  2 1/3 (33.33%)  1 1/4 (25.00%)  1 1/2 (50.00%)  1
Leukocytes (Total WBC)  1  1/1 (100.00%)  1 1/1 (100.00%)  1 3/3 (100.00%)  3 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 4/4 (100.00%)  4 3/3 (100.00%)  3 3/3 (100.00%)  3 3/4 (75.00%)  3 2/2 (100.00%)  2
Lymphopenia  1  1/1 (100.00%)  1 1/1 (100.00%)  1 3/3 (100.00%)  3 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 4/4 (100.00%)  4 3/3 (100.00%)  3 3/3 (100.00%)  3 3/4 (75.00%)  3 2/2 (100.00%)  2
Neutrophils/granulocytes (ANC/AGC)  1  1/1 (100.00%)  1 1/1 (100.00%)  1 3/3 (100.00%)  3 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 4/4 (100.00%)  4 3/3 (100.00%)  3 3/3 (100.00%)  3 3/4 (75.00%)  3 2/2 (100.00%)  2
Platelets  1  1/1 (100.00%)  1 1/1 (100.00%)  1 3/3 (100.00%)  3 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 4/4 (100.00%)  4 2/3 (66.67%)  2 3/3 (100.00%)  3 3/4 (75.00%)  3 1/2 (50.00%)  1
PTT (Partial Thromboplstin Time)  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 1/2 (50.00%)  1
Cardiac disorders                       
Supraventricular and nodal arrhythmia  1  1/1 (100.00%)  1 0/1 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 2/4 (50.00%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Hypotension  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 3/4 (75.00%)  3 1/3 (33.33%)  1 3/3 (100.00%)  3 1/4 (25.00%)  1 1/2 (50.00%)  1
Ear and labyrinth disorders                       
Hearing: patients with/without baseline audiogram and enrolled in a monitoring program  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Eye disorders                       
Ocular/Visual-Other (vision changes)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Gastrointestinal disorders                       
Dehydration  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Nausea  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/2 (50.00%)  1
Constipation  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
Mucositis/stomatitis (clinical exam)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
General disorders                       
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  1/1 (100.00%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Fatigue (asthenia, lethargy, malaise)  1  0/1 (0.00%)  0 1/1 (100.00%)  1 3/3 (100.00%)  3 1/1 (100.00%)  1 1/1 (100.00%)  1 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
Pain  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 2/4 (50.00%)  2 0/2 (0.00%)  0
Syndromes - Other (hemaphogocytic syndrome)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Hepatobiliary disorders                       
Liver dysfunction/failure (clinical)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations                       
Infection  1  1/1 (100.00%)  1 1/1 (100.00%)  1 1/3 (33.33%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 2/4 (50.00%)  2 1/3 (33.33%)  1 1/3 (33.33%)  1 3/4 (75.00%)  3 0/2 (0.00%)  0
Febrile neutropenia  1 [1]  0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 1/1 (100.00%)  1 1/1 (100.00%)  1 3/4 (75.00%)  3 1/3 (33.33%)  1 3/3 (100.00%)  3 0/4 (0.00%)  0 1/2 (50.00%)  1
Metabolism and nutrition disorders                       
Albumin, serum-low (hypoalbuminemia)  1  1/1 (100.00%)  1 0/1 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 1/1 (100.00%)  1 1/1 (100.00%)  1 2/4 (50.00%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 2/4 (50.00%)  2 0/2 (0.00%)  0
Phosphate, serum-low (hypophosphatemia)  1  0/1 (0.00%)  0 1/1 (100.00%)  1 0/3 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 1/1 (100.00%)  1 1/4 (25.00%)  1 1/3 (33.33%)  1 2/3 (66.67%)  2 0/4 (0.00%)  0 1/2 (50.00%)  1
Alkaline phosphatase  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 2/4 (50.00%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Calcium, serum-low (hypocalcemia)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Potassium, serum-low (hypokalemia)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
ALT, SGPT (serum glutamic pyruvic transaminase)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 1/2 (50.00%)  1
AST, SGOT (serum glutamic oxaloacetic transaminase)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/2 (0.00%)  0
Creatinine  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 2/4 (50.00%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Uric acid, serum-high (hyperuricemia)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Nervous system disorders                       
Confusion  1  0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Psychosis (hallucinations/delusions)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Somnolence/depressed level of consciousness  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Syncope (fainting)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/2 (0.00%)  0
Renal and urinary disorders                       
Hemorrhage, GU  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Renal failure  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Renal/Genitourinary - Other (low urine output)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                       
Dyspnea (shortness of breath)  1  1/1 (100.00%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 2/4 (50.00%)  2 1/3 (33.33%)  1 1/3 (33.33%)  1 1/4 (25.00%)  1 1/2 (50.00%)  1
Hemorrhage, pulmonary/upper respiratory  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 2/4 (50.00%)  2 1/3 (33.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Hypoxia  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 2/3 (66.67%)  2 2/4 (50.00%)  2 0/2 (0.00%)  0
Pleural effusion (non-malignant)  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/2 (0.00%)  0
Pneumonitis/pulmonary infiltrates  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/2 (0.00%)  0
Pneumothorax  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/2 (0.00%)  0
Vascular disorders                       
Acute vascular leak syndrome  1  0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 2/4 (50.00%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
1
Term from vocabulary, CTCAE (3.0)
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)
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
Layout table for Results Point of Contact information
Name/Title: Dr. Steven Rosenberg
Organization: National Cancer Institute
Phone: 301- 496-4164
EMail: sar@mail.nih.gov
Layout table for additonal information
Responsible Party: Steven Rosenberg, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01218867    
Other Study ID Numbers: 110013
11-C-0013
First Submitted: October 8, 2010
First Posted: October 11, 2010
Results First Submitted: April 15, 2016
Results First Posted: July 22, 2016
Last Update Posted: December 10, 2019