Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy Patients
April 24, 2017 updated by: St. Jude Children's Research Hospital
A Study of Rasburicase Treatment for Chemotherapy of Malignancy-Induced Hyperuricemia in Patients With a History of Asthma Allergies
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
16
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
-
Palo Alto, California, United States, 94304
- Stanford University
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San Diego, California, United States, 92123
- Rady Children's Hospital
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-
Indiana
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Indianapolis, Indiana, United States, 46260
- Peyton Manning Children's Hospital at St. Vincent
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-
Massachusetts
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Boston, Massachusetts, United States, 02115-6084
- Dana-Farber Cancer Institute
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Michigan
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Detroit, Michigan, United States, 48201
- Children's Hospital Michigan
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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-
Tennessee
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Memphis, Tennessee, United States, 38105
- St.Jude Children's Research Hospital
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Texas
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Fort Worth, Texas, United States, 76104
- Cook Children's Medical Center
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226-4801
- Mid-West Children's Cancer Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients at high risk of tumor lysis syndrome who have a history of asthma, eczema, or significant allergies (to substances other than rasburicase).
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
|
Rasburicase 0.2 mg/kg/dose by the intravenous route for up to 7 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of grade 3 or 4 allergic reactions
Time Frame: Within 30 days of last treatment administration
|
Within 30 days of last treatment administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Raul C. Ribeiro, MD, St. Jude Children's Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Actual)
April 25, 2017
Last Update Submitted That Met QC Criteria
April 24, 2017
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RASALL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.