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| Sponsored by: |
Sanofi-Aventis |
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00230217 |
Purpose
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.
| Condition | Intervention | Phase |
|
Tumors Hyperuricemia Tumor Lysis Syndrome |
Drug: Rasburicase (SR29142) |
Phase IV |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma |
| ChemIDplus related topics: | Rasburicase |
| Study Type: | Interventional |
| Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment |
| 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 |
| Enrollment: | 94 |
| Study Start Date: | March 2004 |
| Study Completion Date: | July 2006 |
This is a multi-center, 2 arm, open-label study;
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.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Meets one of the following risk criteria for tumor lysis syndrome (TLS):
A patient is at high risk for TLS if he/she presents with:
A patient is at potential risk for TLS if he/she presents with:
A diagnosis of an aggressive lymphoma/leukemia based on the REAL classification of lymphoma/leukemia plus 1 or more of the following criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |||||
| Alta Bates Comprehensive Cancer Center | |||||
| Berkley, California, United States, 94704 | |||||
| United States, Colorado | |||||
| Rocky Mountain Cancer Center | |||||
| Denver, Colorado, United States, 80218 | |||||
| United States, Florida | |||||
| University of Florida Health Science Center at Jacksonville | |||||
| Jacksonville, Florida, United States, 32209 | |||||
| United States, New York | |||||
| New York Medical College | |||||
| Valhalla, New York, United States, 10595 | |||||
| United States, Oklahoma | |||||
| University of Oklahoma HSC | |||||
| Oklahoma City, Oklahoma, United States, 73104 | |||||
| United States, Pennsylvania | |||||
| University of Pennsylvania Health Systems | |||||
| Philadelphia, Pennsylvania, United States, 19104 | |||||
| United States, West Virginia | |||||
| Mary Babb Randolph Cancer Center | |||||
| Morgantown, West Virginia, United States, 26506-9162 | |||||
| Sanofi-Aventis |
| Study Director: | ICD CSD | Sanofi-Aventis |
More Information
Related Info 
  |
| Responsible Party: | sanofi-aventis ( ICD Study Director ) |
| Study ID Numbers: | EFC5339, SR29142 |
| First Received: | September 28, 2005 |
| Last Updated: | June 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00230217 |
| Health Authority: | United States: Food and Drug Administration |
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