50
Participants
Start Date
March 31, 2006
Primary Completion Date
May 31, 2010
Study Completion Date
May 31, 2010
clofarabine
Clofarabine 20-40 mg/m²/day 2 hour intravenous (IV) infusion daily for 5 days of a 28 day cycle as the first of the three IV interventions administered. Maximum of 8 cycles given in both the phase 1 and phase 2 study periods.
Etoposide
Etoposide 75-100 mg/m²/day 2 hour intravenous (IV) infusion daily for 5 days of a 28 day cycle following clofarabine therapy. Maximum of 8 cycles given in both the phase 1 and phase 2 study periods.
Cyclophosphamide
Cyclophosphamide 340-440 mg/m²/day as 30-60 minute intravenous (IV) infusion daily for 5 days of a 28 day cycle following the other two interventions. Maximum of 8 cycles given in both the phase 1 and phase 2 study periods.
Children's Hospital of Alabama, Birmingham
Children's Hospital of Los Angeles, Los Angeles
Rady Children's Hospital, San Diego
Connecticut Children's Medical Center, Hartford
Children's Memorial Hospital, Chicago
St. Vincent Children's Hospital, Indianapolis
Dana Farber Cancer Institute, Boston
Children's Hospital of Michigan, Detroit
Memorial Sloan-Kettering Cancer Center, New York
New York School of Medicine, New York
St. Jude Children's Research Hospital, Memphis
University of Texas MD Anderson Cancer Center, Houston
Seattle Children's Hospital, Seattle
Genzyme, a Sanofi Company
INDUSTRY