12
Participants
Start Date
November 30, 2014
Primary Completion Date
January 31, 2018
Study Completion Date
October 31, 2018
Cyclophosphamide
Cyclophosphamide 60 mg/kg are administered i.v on day -7 and -6
Fludarabine
Fludarabine 25 mg/m2 are administered i.v on day -5 to -1
TIL infusion
The maximum number of expanded TILs are infused over 30-45 min on day 0
Interleukin-2
Interleukin-2 are administered as a continuous i.v. infusion in a decrescendo regimen (18 MIU/m2 IL-2 over 6 hours, 18 MIU/m2 IL-2 over 12 hours, 18 MIU IL-2 over 24 hours followed by 4.5 MIU/m2 IL-2 over another 24 hours for three days)
Peginterferon alfa-2b
Peginterferon alpha-2b, 3 microgram/kg are administered as subcutaneous injection on day -2, day 7 and day 14.
Center for Cancer Immune Therapy, Dept. of Haematology/Oncology, Copenhagen
Inge Marie Svane
OTHER