12
Participants
Start Date
October 31, 2006
Primary Completion Date
November 30, 2008
Study Completion Date
November 30, 2008
anti-protein 53 or tumor protein 53 (p53) T-cell receptor transduced peripheral blood lymphocytes
Peripheral blood lymphocytes are harvested by lymphapheresis and engineered to express a T cell receptor that binds to P53.
aldesleukin
720,000 IU/kg intravenously over 15 minutes every 8 hours for up to 5 days
filgrastim
Beginning on day 1 or 2, administered subcutaneously at a dose of 5 mcg/kg/day (not to exceed 300 mcg/day); continue daily until neutrophil count \> 1.0 x 10\^9/L x 3 days or \> 5.0 x 10\^9/L.
cyclophosphamide
60 mg/kg/day x 2 days intravenously in 250ml dextrose 5% in water (D5W) with mesna 15 mg/kg/day x 2 days over 1 hour.
fludarabine phosphate
25 mg/m2/day intravenously piggyback (IVPB) daily over 30 minutes for 5 days.
National Institutes of Health, Bethesda
National Cancer Institute (NCI)
NIH