30
Participants
Start Date
May 21, 2013
Primary Completion Date
February 14, 2017
Study Completion Date
February 27, 2017
administration of ipilimumab10mg/kg
"Ipilimumab IV infusion:~* Day 0 (within 1-2 weeks of baseline biopsy) every 3 weeks for 2 doses followed by definitive surgery~* After surgery recover-y resume at the same dose for 2 additional doses given 3 weeks apart~* Dose continued 12 weeks later for 4 additional doses given 12 weeks apart~Interferon Alfa-2b will be given concurrently with ipilimumab. Each patient will receive Interferon Alfa-2b at 20 MU/m²/day intravenously for 5 consecutive days out of 7 every week for 4 weeks, followed by 10 MU/m²/d subcutaneously every other day, 3 times each week for 2 weeks, followed by definitive surgery. After surgery recovery, Interferon Alfa-2b will be resumed at 10 MU/m²/d subcutaneously, every other day three times a week for 46 additional weeks."
administration of ipilimumab 3mg/kg + HDI
"Ipilimumab IV infusion:~* Day 0 (within 1-2 weeks of baseline biopsy) every 3 weeks for 2 doses followed by definitive surgery~* After surgery recover-y resume at the same dose for 2 additional doses given 3 weeks apart~* Dose continued 12 weeks later for 4 additional doses given 12 weeks apart~Interferon Alfa-2b will be given concurrently with ipilimumab. Each patient will receive Interferon Alfa-2b at 20 MU/m²/day intravenously for 5 consecutive days out of 7 every week for 4 weeks, followed by 10 MU/m²/d subcutaneously every other day, 3 times each week for 2 weeks, followed by definitive surgery. After surgery recovery, Interferon Alfa-2b will be resumed at 10 MU/m²/d subcutaneously, every other day three times a week for 46 additional weeks."
UPMC Hillman Cancer Center, Pittsburgh
Diwakar Davar
OTHER