29
Participants
Start Date
April 13, 2012
Primary Completion Date
April 9, 2016
Study Completion Date
August 1, 2016
Fludarabine
Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Cyclophosphamide
Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
Young TIL
Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
Aldesleukin
Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda
National Cancer Institute (NCI)
NIH