1,230
Participants
Start Date
February 1, 2006
Primary Completion Date
February 28, 2030
Study Completion Date
February 28, 2030
Dendritic Cell Immunization
1x10\^7 to 2.5x10\^8 MART-1 peptide-pulsed Dendritic Cells given by vein over 20-30 minutes approximately 4 hrs after receiving T cells.
Cyclophosphamide
60 mg/kg/d by vein over 2 hours on Days -7 and -6 before T cell infusion
Fludarabine
25 mg/m\^2 by vein daily over 30 minutes on Days -5 to -1 before T cell infusion.
T-Cells
On Days 0, up to 1.5 x 10\^11 T-cells by vein infusion over 30-60 minutes.
Interleukin-2
12-16 hours after completing the T cell infusion, all will receive high dose IL-2 on an inpatient basis at the standard dose of 720,000 IU/kg as an intravenous bolus over approximately a 15 minute period every 8-16 hours for up to 15 doses on Days 1-5 and 22-26 (+/- 7 days), as tolerated.
Mesna
60 mg/kg with D5W or NS at 125 ml/hr infused intravenously over 24 hours on Day -7 and -6.
Intrathecal T-Cells
5.0x10\^9 T-cells administered on Day 1, and 10x10\^9 T-cells on Day 15. 1.2 MIU of IL- 2 on Day 2, 4, 9, 11, 16 and 18 as tolerated.
Intrathecal Interleukin-2
1.2 MIU of IL- 2 on Day 2, 4, 9, 11, 16 and 18 as tolerated. Then, patient receives twice weekly IL-2 that will be gradually changed to weekly IL-2. After 4-6 weeks patients switched to IL-2 maintenance.
The University of Texas MD Anderson Cancer Center, Houston
Collaborators (3)
Prometheus Laboratories
INDUSTRY
Key Biologics, LLC
INDUSTRY
National Cancer Institute (NCI)
NIH
Adelson Medical Research
UNKNOWN
M.D. Anderson Cancer Center
OTHER