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| Descriptive Information Fields | |||||
| Brief Title † | Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy Patients | ||||
| Official Title † | A Study of Rasburicase Treatment for Chemotherapy of Malignancy-Induced Hyperuricemia in Patients With a History of Asthma Allergies | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study | ||||
| Primary Outcome Measure † | Incidence of grade 3 or 4 allergic reactions [ Time Frame: Within 30 days of last treatment administration ] [ Designated as safety issue: Yes ] | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Leukemia Lymphoma Tumor Lysis Syndrome Hyperuricemia |
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| Intervention † | Drug: Rasburicase | ||||
| MEDLINE PMIDs | |||||
| Links | St. Jude Children's Research Hospital ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 72 | ||||
| Start Date † | March 2005 | ||||
| Completion Date | December 2008 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00186940 | ||||
| Organization ID | RASALL | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | St. Jude Children's Research Hospital | ||||
| Collaborators †† | Sanofi-Aventis | ||||
| Investigators † |
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| Information Provided By | St. Jude Children's Research Hospital | ||||
| Verification Date | December 2008 | ||||
| First Received Date † | September 12, 2005 | ||||
| Last Updated Date | December 1, 2008 | ||||