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Brief Title: Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome
Official Title: Evaluation of Single Agent Rasburicase for 5 Days Versus Sequential Treatment With Rasburicase From Day 1 Through 3 Followed by Oral Allopurinol From Day 3 Through 5 (Overlap on Day 3) Versus Single Agent Oral Allopurinol for 5 Days in the Management of Plasma Uric Acid in Adult Patients With Leukemia, Lymphoma, and Solid Tumor Malignancies at Risk for Hyperuricemia and Tumor Lysis Syndrome
Study ID: NCT00230178
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Alta Bates Comprehensive Cancer Center, Berkeley, California, United States
UCLA Medical Center, Los Angeles, California, United States
Rocky Mountain Cancer Center, Denver, Colorado, United States
University of Florida Health Science Center at Jacksonville, Jacksonville, Florida, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
New York Methodist Hospital, Brooklyn, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
New York Medical College, Valhalla, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Oregon Health and Sciences University, Portland, Oregon, United States
University of Pennsylvania Health Systems, Philadelphia, Pennsylvania, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Mary Babb Randolph Cancer Center, Morgantown, West Virginia, United States
Name: International Clinical Development
Affiliation: Sanofi
Role: STUDY_DIRECTOR