CAR T Cell Receptor Immunotherapy Targeting VEGFR2 for Patients With Metastatic Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01218867 |
Recruitment Status :
Terminated
(No objective responses were observed.)
First Posted : October 11, 2010
Results First Posted : July 22, 2016
Last Update Posted : December 10, 2019
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Metastatic Cancer Metastatic Melanoma Renal Cancer |
Interventions |
Biological: Anti-VEGFR2 CAR CD8 plus PBL Drug: Cyclophosphamide Biological: Aldesleukin Drug: Fludarabine |
Enrollment | 24 |
Recruitment Details | |
Pre-assignment Details | Twenty-four participants were enrolled but one participant was not treated due to a new cancer diagnosis which made the participant ineligible for this protocol. |
Arm/Group Title | Cohort 1 - 1 x 10(6) Cells (High Dose IL-2) | Cohort 2 - 3 x 10(6) Cells (High Dose IL-2) | Cohort 3 - 1 x 10(7) Cells (High Dose IL-2) | Cohort 4 - 3 x 10(7) Cells (High Dose IL-2) | Cohort 5 - 1 x 10(8) Cells (High Dose IL-2) | Cohort 6 - 3 x 10(8) Cells (High Dose IL-2) | Cohort 7 - 1 x 10(9) Cells (High Dose IL-2) | Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2) | Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2) | Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2) | Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2) |
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Anti-vascular endothelial growth factor receptor 2 (VEGFR2) chimeric T cell receptor (CAR) cluster of differentiation 8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days |
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days |
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days |
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days |
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days |
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days |
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days |
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days |
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days |
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days |
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1) Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses) Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days |
Period Title: Overall Study | |||||||||||
Started | 1 | 1 | 3 | 1 | 1 | 1 | 4 | 3 | 3 | 4 | 2 |
Completed | 1 | 1 | 3 | 1 | 1 | 1 | 3 | 3 | 3 | 4 | 2 |
Not Completed | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Reason Not Completed | |||||||||||
Death during treatment | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Arm/Group Title | Cohort 1 - 1 x 10(6) Cells (High Dose IL-2) | Cohort 2 - 3 x 10(6) Cells (High Dose IL-2) | Cohort 3 - 1 x 10(7) Cells (High Dose IL-2) | Cohort 4 - 3 x 10(7) Cells (High Dose IL-2) | Cohort 5 - 1 x 10(8) Cells (High Dose IL-2) | Cohort 6 - 3 x 10(8) Cells (High Dose IL-2) | Cohort 7 - 1 x 10(9) Cells (High Dose IL-2) | Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2) | Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2) | Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2) | Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2) | Total | |
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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 | |
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[Not Specified]
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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%
|
Name/Title: | Dr. Steven Rosenberg |
Organization: | National Cancer Institute |
Phone: | 301- 496-4164 |
EMail: | sar@mail.nih.gov |
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 |