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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven Rosenberg, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01218867
First received: October 8, 2010
Last updated: November 8, 2016
Last verified: October 2016
History of Changes
Results First Received: April 15, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: 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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)

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
Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)

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
Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)

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
Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)

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
Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)

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
Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)

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
Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)

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
Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)

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
Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)

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
Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)

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
Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)

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

Participant Flow:   Overall Study
    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)
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 
Death during treatment                0                0                0                0                0                0                1                0                0                0                0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)

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
Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)

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
Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)

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
Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)

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
Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)

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
Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)

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
Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)

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
Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)

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
Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)

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
Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)

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
Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)

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 Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 		 1   1   3   1   1   1   4   3   3   4   2   24 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation) 		 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) 
Gender 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
 		                       
United States   1   1   3   1   1   1   4   3   3   4   2   24 


  Outcome Measures
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1.  Primary:   Response to Therapy   [ Time Frame: 6 years ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 33 months and 25 days ]
  Show Outcome Measure 2

3.  Secondary:   In Vivo Survival of Chimeric T Cell Receptor (CAR) Gene-engineered Cells   [ Time Frame: 6 years ]
  Show Outcome Measure 3


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: sar@mail.nih.gov


Publications:


Responsible Party: Steven Rosenberg, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01218867     History of Changes
Other Study ID Numbers: 110013
11-C-0013
Study First Received: October 8, 2010
Results First Received: April 15, 2016
Last Updated: November 8, 2016