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Spots Global Cancer Trial Database for Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome

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We do not endorse or review these studies in any way.

Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: International Clinical Development

Affiliation: Sanofi

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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