19
Participants
Start Date
February 28, 2013
Primary Completion Date
May 31, 2016
Study Completion Date
May 31, 2016
Ipilimumab
"Phase I Starting dose: 1 mg/kg by vein over 90 minutes on Day 1 of each 3 week cycle for Induction 12 weeks, then Day 1 of Cycle 1 for Consolidation 12 weeks and Day 1 of each 12 week cycle in Maintenance.~Phase II dose: Maximum tolerated dose (MTD) from Phase I."
Temozolomide
200 mg/m\^2 by mouth 1 time a day on Days 2-5 of each Induction cycle (four 3 week cycles).
Cisplatin
25 mg/m\^2 by vein over 1 hour on Days 2-4 of each Induction cycle (four 3 week cycles).
Interferon Alfa-2b
5 million U/m2 subcutaneously on Days 2-6 of each 3 week Induction cycle (four 3 week cycles) and each 4 week Consolidation cycle (three 4 week cycles).
Interleukin-2
9 million IU/m\^2 by vein as a continuous infusion on Days 2-5 of each 3 week Induction cycle (four 3 week cycles) and each 4 week Consolidation cycle (three 4 week cycles).
University of Texas MD Anderson Cancer Center, Houston
Collaborators (1)
Bristol-Myers Squibb
INDUSTRY
M.D. Anderson Cancer Center
OTHER