35
Participants
Start Date
January 31, 2007
Primary Completion Date
June 30, 2009
Study Completion Date
February 29, 2012
terameprocol
terameprocol will be given IV 5 consecutive days every 28 days. Starting dose 750mg/day. Cohorts of 3pts. A Dose Limiting Toxicity (DLT) target rate of Less than or equal to 33%. Dose levels: 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, 9300 mg.
pharmacological study
All pts on both arms will have pks, blood collections. 5ml of blood will be drawn on Cycle 1 day 1, Cycle 1 Day 5, Cycle 2 day 1 and Cycle 2 day 5. A total of 10 samples will be drawn at each of these time points. 1hr pre-infusion, 15 min, 1hr, 1.15, 1.5, 2, 3,4,6 and 24hr post infusion.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore
Winship Cancer Institute of Emory University, Atlanta
Cleveland Clinic Taussig Cancer Center, Cleveland
Josephine Ford Cancer Center at Henry Ford Hospital, Detroit
UAB Comprehensive Cancer Center, Birmingham
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa
Massachusetts General Hospital, Boston
Wake Forest University Comprehensive Cancer Center, Winston-Salem
Abramson Cancer Center of the University of Pennsylvania, Philadelphia
National Cancer Institute (NCI)
NIH
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER