Overview

Rasburicase in Patients at Risk for Tumor Lysis Syndrome

Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
Summary
Primary Objectives: To determine the efficacy of rasburicase administered as a single dose followed by as needed dosing (investigational arm) as compared to fixed dosing for 5 days (standard treatment arm) in the treatment of patients at high risk or potential risk for tumor lysis syndrome. Secondary Objectives: 1. To evaluate the plasma uric acid area under the curve (AUC) from baseline through 7 days 2. To evaluate the incidence of renal insufficiency and electrolyte abnormalities. 3. To determine the safety and immunogenicity of rasburicase. 4. To evaluate the cost-effectiveness of the experimental treatment (investigational arm).
Phase:
Phase 2
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Sanofi
Treatments:
Rasburicase