Efficacy and Safety of Two Comparable Single Low Doses of Rasburicase Followed by Allopurinol in Adult Patients With Malignancy
I. To prospectively evaluate the efficacy, as defined by uric acid response rate, of 2
different low doses of rasburicase followed by allopurinol in 2 treatment arms.
I. To estimate the proportion of patients requiring additional doses of rasburicase to
maintain a uric acid level =< 7.5mg/dL on day 2 through day 6.
II. To identify differential characteristics of the patients who do not respond to
III. to measure the area under the plasma uric acid concentration-time curve (AUC) from
baseline (Day 1) to Day 7, time to plasma uric acid level less than or equal to 7.5mg/dL.
IV. To evaluate the rate of patients requiring hemodialysis (HD) V. To evaluate the safety
of low single-doses of rasburicase. VI. To evaluate the rate of patients expressing a
doubling of serum creatinine.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive 1.5mg of rasburicase intravenously (IV) over 30 minutes on day 1*
and allopurinol orally (PO) once daily (QD) on days 1-6.
ARM II: Patients receive 3 mg of rasburicase IV over 30 minutes on day 1* and allopurinol PO
QD on days 1-6.
NOTE: *Patients with serum uric acid >= 7.5mg/dl also receive rasburicase IV on days 2-3.
After completion of study treatment, patients are followed up at 30 days.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Probability of obtaining a uric acid level =< 7.5mg/dL
The sample proportion responding and the lower one-sided Wilson Score confidence limits will be calculated for each treatment arm. Other descriptive statistics and graphical comparisons will be provided as needed.
Within 24 hours of rasburicase treatment
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|