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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00230178 |
Purpose
This is a randomized, multi-center, open-label, parallel group study with three arms:
The primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms.
| Condition | Intervention | Phase |
|---|---|---|
|
Tumor Lysis Syndrome Cancer Hyperuricemia |
Drug: Rasburicase Drug: Allopurinol |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| 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 |
| Enrollment: | 280 |
| Study Start Date: | April 2004 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm A: Experimental
Rasburicase alone given as a single agent for 5 days
|
Drug: Rasburicase
30-min IV infusion
|
|
Arm B: Experimental
Rasburicase alone given as a single agent from Day 1 through Day 3, followed by oral allopurinol given from Day 3 through Day 5 (Day 3 is an overlap)
|
Drug: Rasburicase
30-min IV infusion
Drug: Allopurinol
Oral administration
|
|
Arm C: Active Comparator
Oral allopurinol alone given as a single agent for 5 days
|
Drug: Allopurinol
Oral administration
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Meets high risk or at potential risk 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 aggressive lymphoma/leukemia based on the REAL classification of lymphoma/leukemia plus 1 or more of the following criteria:
In addition to the above-mentioned eligibility criteria, the patients should have the following 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, 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 | |
| Study Director: | ICD | Sanofi-Aventis |
More Information
| Responsible Party: | sanofi-aventis ( ICD Study Director ) |
| Study ID Numbers: | EFC4978, SR29142 |
| Study First Received: | September 28, 2005 |
| Last Updated: | August 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00230178 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Hyperuricemia Tumor lysis syndrome Leukemia Lymphoma |
Myelodysplastic Syndromes Solid tumor cancers Solid Tumor cancers with hyperuricemia Hyperuricemia (cancer patients only) Tumor lysis syndrome (cancer patients only) |
|
Antimetabolites Allopurinol Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Gout Suppressants Leukemia Pathologic Processes Syndrome Therapeutic Uses Free Radical Scavengers Lymphoma Disease |
Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Hyperuricemia Enzyme Inhibitors Rasburicase Protective Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Tumor Lysis Syndrome Lymphoproliferative Disorders Antirheumatic Agents |