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Brief Title: Study of Rasburicase as Treatment or Prevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Patients With Relapsed or Refractory Lymphoma, Leukemia, or Solid Tumor Malignancy
Official Title: Evaluation of Single Agent Rasburicase in Treatment/Prevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Adult and Pediatric Patients With Lymphoma/Leukemia/Solid Tumor Malignancies at Their First Relapse or Refractory Disease
Study ID: NCT00230217
Brief Summary: This is an open-label, multi-center study with 2 arms. The primary objective is to assess the response to treatment with rasburicase in 2 populations of adult and pediatric patients with lymphoma/leukemia/solid tumor malignancies, those previously treated with a uricolytic agent, and those not previously treated with a uricolytic agent at their first relapse or refractory disease.
Detailed Description: This is a multi-center, 2 arm, open-label study; * Arm A: Patients previously treated with a uricolytic agent; * Arm B: Patients not previously treated with a uricolytic agent. Patients receive rasburicase for 5 days and begin chemotherapy 4-24 hours after the first dose of rasburicase. Patients are followed at 14 and 35 days, at 3 and 6 months and every 6 months thereafter.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Alta Bates Comprehensive Cancer Center, Berkley, California, United States
Rocky Mountain Cancer Center, Denver, Colorado, United States
University of Florida Health Science Center at Jacksonville, Jacksonville, Florida, United States
New York Medical College, Valhalla, New York, United States
University of Oklahoma HSC, Oklahoma City, Oklahoma, United States
University of Pennsylvania Health Systems, Philadelphia, Pennsylvania, United States
Mary Babb Randolph Cancer Center, Morgantown, West Virginia, United States
Name: ICD CSD
Affiliation: Sanofi
Role: STUDY_DIRECTOR