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

• ClinicalTrials.gov Identifier: NCT01218867
• Recruitment Status: Terminated
• First Posted: October 11, 2010
• Results First Posted: July 22, 2016
• Last Update Posted: December 10, 2019
• Sponsor: National Cancer Institute (NCI)
• 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

Participant Flow

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)
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

Baseline Characteristics

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
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
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%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With a Response to Therapy
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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.

Adverse Events

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)
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%)
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
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)

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Dr. Steven Rosenberg
• Organization: National Cancer Institute
• Phone: 301- 496-4164
• EMail: sar@mail.nih.gov

Publications:

Rosenberg SA. Progress in human tumour immunology and immunotherapy. Nature. 2001 May 17;411(6835):380-4. Review.

Berendt MJ, North RJ. T-cell-mediated suppression of anti-tumor immunity. An explanation for progressive growth of an immunogenic tumor. J Exp Med. 1980 Jan 1;151(1):69-80.

Gattinoni L, Powell DJ Jr, Rosenberg SA, Restifo NP. Adoptive immunotherapy for cancer: building on success. Nat Rev Immunol. 2006 May;6(5):383-93. Review.

• 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