Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy Patients
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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 4 |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | A Study of Rasburicase Treatment for Chemotherapy of Malignancy-Induced Hyperuricemia in Patients With a History of Asthma Allergies |
- Incidence of grade 3 or 4 allergic reactions [ Time Frame: Within 30 days of last treatment administration ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 72 |
| Study Start Date: | March 2005 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 1 |
Drug: Rasburicase
Rasburicase 0.2 mg/kg/dose by the intravenous route for up to 7 days.
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients at high risk of tumor lysis syndrome who have a history of asthma, eczema, or significant allergies (to substances other than rasburicase).
Inclusion Criteria:
- A diagnosis of hematologic malignancy.
- Existing hyperuricemia or high risk of developing hyperuricemia of malignancy.
- The treating clinician plans to treat the patient with rasburicase. A patient is only eligible for RASALL if the clinician has already decided to use rasburicase. Rasburicase should not be given in order to make a patient eligible for this non-therapeutic observational study.
- No prior exposure to rasburicase or other urate oxidase.
- A history of asthma or significant allergy.
Exclusion Criteria
- Wheezing or an active hypersensitivity reaction at entry.
- Hypersensitivity to Aspergillus proteins.
Contacts and Locations| United States, California | |
| Stanford University | |
| Palo Alto, California, United States, 94304 | |
| Rady Children's Hospital | |
| San Diego, California, United States, 92123 | |
| United States, Indiana | |
| Peyton Manning Children's Hospital at St. Vincent | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115-6084 | |
| United States, Michigan | |
| Children's Hospital Michigan | |
| Detroit, Michigan, United States, 48201 | |
| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, Tennessee | |
| St.Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| United States, Texas | |
| Cook Children's Medical Center | |
| Fort Worth, Texas, United States, 76104 | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United States, Wisconsin | |
| Mid-West Children's Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226-4801 | |
| Principal Investigator: | Raul C. Ribeiro, MD | St. Jude Children's Research Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT00186940 History of Changes |
| Other Study ID Numbers: | RASALL |
| Study First Received: | September 12, 2005 |
| Last Updated: | October 5, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by St. Jude Children's Research Hospital:
|
leukemia |
Additional relevant MeSH terms:
|
Leukemia Lymphoma Tumor Lysis Syndrome Hyperuricemia Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Pathologic Processes Rasburicase Gout Suppressants Antirheumatic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013