25
Participants
Start Date
July 31, 2008
Primary Completion Date
December 31, 2012
Study Completion Date
December 31, 2012
Arsenic Trioxide, Ascorbic Acid and Bortezomib
"Phase I/Cohort I~Loading:~1. Arsenic Trioxide (ATO): 0.25 mg/kg IV over 1-2 hr qd x 5 days (Monday-Friday)~2. Ascorbic Acid: 1000 mg by IV infusion over 15 minutes after each infusion of arsenic trioxide qd x 5 days~Maintenance cycles (21 days)~1. ATO: 0.25 mg/kg IV over 1-2 hr once a week x 2 weeks every 3 weeks (one cycle) for a total of 6 cycles.~2. Ascorbic Acid 1000mg IV will be given within 30 minutes of completion of ATO.~3. Bortezomib 1 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 8 of a 21-day cycle. ATO is given at least one hour prior to Bortezomib. The first cycle will start on week 2, after loading dose week.~Phase I/Cohort 1 is followed by Cohort 2. Phase II uses maximum tolerated dose from Phase I."
Duke University Medical Center, Durham
Lead Sponsor
Collaborators (1)
Cephalon
INDUSTRY
Duke University
OTHER