This is a randomized, multi-center, open-label, parallel group study with three arms: * Rasburicase alone * Rasburicase followed by Allopurinol * Allopurinol alone The primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms.
After signing the informed consent and having met the inclusion criteria, patients will be randomized to 1 of the 3 arms and treated for a total duration of 5 days. Patients in all arms will receive chemotherapy beginning 4-24 hours after the first dose of rasburicase or allopurinol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
280
30-min IV infusion
Oral administration
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States
UCLA Medical Center
Los Angeles, California, United States
Plasma Uric Acid Responder
Number of patients responding to treatment defined as plasma uric acid levels at Day 3 through Day 7 \<7.5 mg/dl.
Time frame: Day 3 through Day 7
Plasma Uric Acid
Area under the curve concentration versus time curve extrapolated to infinity (AUC) of plasma uric acid values
Time frame: Day 1 to Day 7
Time to Uric Acid Control
Time from the first dose of study drug to the time at which plasma uric acid concentrations were determined \<=7.5 mg/dl, measured -4, 4, 24, 48, 72, 96, 120, and 144 hours after infusion.
Time frame: Day 1 to Day 7
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