Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy Patients
- Registration Number
- NCT00186940
- Lead Sponsor
- St. Jude Children's Research Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Rasburicase -
- Primary Outcome Measures
Name Time Method Incidence of grade 3 or 4 allergic reactions Within 30 days of last treatment administration
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Stanford University
🇺🇸Palo Alto, California, United States
Rady Children's Hospital
🇺🇸San Diego, California, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Children's Hospital Michigan
🇺🇸Detroit, Michigan, United States
St.Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Mid-West Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Cook Children's Medical Center
🇺🇸Fort Worth, Texas, United States
Peyton Manning Children's Hospital at St. Vincent
🇺🇸Indianapolis, Indiana, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States