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| Sponsors and Collaborators: |
St. Jude Children's Research Hospital Sanofi-Aventis |
|---|---|
| Information provided by: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT00186940 |
Purpose
This is a multi-center trial for rasburicase in children at high risk of tumor lysis syndrome who have a history of asthma/atopy. The main purpose of this study is to establish the safety of this drug in patients with a history of asthma or severe allergies.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma Tumor Lysis Syndrome Hyperuricemia |
Drug: Rasburicase |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | A Study of Rasburicase Treatment for Chemotherapy of Malignancy-Induced Hyperuricemia in Patients With a History of Asthma Allergies |
| Estimated Enrollment: | 72 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1 |
Drug: Rasburicase
Rasburicase 0.2 mg/kg/dose by the intravenous route for up to 7 days.
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Because they were excluded from most of the clinical trials of non-recombinant urate oxidase and rasburicase, the safety of rasburicase in this population is not known, though preliminary data indicates that the drug is safe. The primary objective of this study is to estimate the proportion of grade 3 or 4 allergic reactions to rasburicase in patients with a history of asthma or severe allergy (to antigens other than rasburicase or other urate oxidases) treated with rasburicase for the prevention or treatment of malignancy or chemotherapy-induced hyperuricemia. Patients at risk of tumor lysis syndrome with a history of asthma/atopy will be treated with rasburicase according to standard practice and observed for allergic reactions.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
Contacts and Locations| Contact: Raul C. Ribeiro, MD | 1-866-278-5833 | info@stjude.org |
| United States, California | |
| Stanford University | Recruiting |
| Palo Alto, California, United States, 94304 | |
| United States, Indiana | |
| Peyton Manning Children's Hospital at St. Vincent | Recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| Contact: Bassem Razzouk, MD | |
| Principal Investigator: Bassem Razzouk, MD | |
| United States, Maine | |
| Maine Medical Center | Recruiting |
| Portland, Maine, United States, 04102 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115-6084 | |
| United States, Michigan | |
| Children's Hospital Michigan | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| United States, Rhode Island | |
| Rhode Island Hospital | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Contact: Cindy Schwartz, MD | |
| Principal Investigator: Cindy Schwartz, MD | |
| United States, Tennessee | |
| St.Jude Children's Research Hospital | Recruiting |
| Memphis, Tennessee, United States, 38105 | |
| Contact: Raul C. Ribeiro, MD 866-278-5833 info@stjude.org | |
| Principal Investigator: Raul C. Ribeiro, MD | |
| United States, Texas | |
| Cook Children's Medical Center | Recruiting |
| Fort Worth, Texas, United States, 76104 | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| United States, Wisconsin | |
| Mid-West Children's Cancer Center | Recruiting |
| Milwaukee, Wisconsin, United States, 53226-4801 | |
| Principal Investigator: | Raul C. Ribeiro, MD | St. Jude Children's Research Hospital |
More Information
| Responsible Party: | St. Jude Children's Research Hospital ( Raul C. Ribeiro, Principal Investigator ) |
| Study ID Numbers: | RASALL |
| Study First Received: | September 12, 2005 |
| Last Updated: | December 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00186940 |
| Health Authority: | United States: Institutional Review Board |
|
leukemia |
|
Lymphatic Diseases Leukemia Hypersensitivity Immunoproliferative Disorders Hyperuricemia |
Asthma Tumor Lysis Syndrome Lymphoproliferative Disorders Rasburicase Lymphoma |
|
Neoplasms Disease Neoplasms by Histologic Type Pathologic Processes Immune System Diseases |
Therapeutic Uses Syndrome Antirheumatic Agents Gout Suppressants Pharmacologic Actions |
