24
Participants
Start Date
June 30, 2007
Primary Completion Date
July 31, 2011
Study Completion Date
July 31, 2012
autologous anti-MART-1 F5 T-cell receptor
"Autologous anti-MART-1 F5 T-cell receptor gene-engineered tumor infiltrating lymphocytes.~A minimum of approximately 5 X 10\^8 cells will be given up to 3x10\^11 anti-MART-1 F5 TCR engineered TIL or PBL."
Cyclophosphamide
Day -7 to -5: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Fludarabine
Day -5 to 1: Fludarabine 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days
Aldesleukin
Day 0: Cells will be infused intravenously (i.v.). Patients will receive up to 3x10e\^11 (with a minimum of 5x10e\^8 cells) anti-MART-1 F5 TCR engineered TIL or PBL Aldesleukin (based on total body weight) 720,000 IU/kg intravenous (IV) over 15 minute every eight hours beginning within 24 hours of cell infusion
autologous anti-MART-1 F5 T-cell receptor gene-engineered tumor infiltrating lymphocytes
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda
National Cancer Institute (NCI)
NIH