Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy Patients
Information source: St. Jude Children's Research Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia; Lymphoma; Tumor Lysis Syndrome; Hyperuricemia
Intervention: Rasburicase (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: St. Jude Children's Research Hospital Official(s) and/or principal investigator(s): Raul C. Ribeiro, MD, Principal Investigator, Affiliation: St. Jude Children's Research Hospital
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.
Clinical Details
Official title: A Study of Rasburicase Treatment for Chemotherapy of Malignancy-Induced Hyperuricemia in Patients With a History of Asthma Allergies
Study design: Time Perspective: Prospective
Primary outcome: Incidence of grade 3 or 4 allergic reactions
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Stanford University, Palo Alto, California 94304, United States
Rady Children's Hospital, San Diego, California 92123, United States
Peyton Manning Children's Hospital at St. Vincent, Indianapolis, Indiana 46260, United States
Dana-Farber Cancer Institute, Boston, Massachusetts 02115-6084, United States
Children's Hospital Michigan, Detroit, Michigan 48201, United States
Columbia University Medical Center, New York, New York 10032, United States
Rhode Island Hospital, Providence, Rhode Island 02903, United States
St.Jude Children's Research Hospital, Memphis, Tennessee 38105, United States
Cook Children's Medical Center, Fort Worth, Texas 76104, United States
MD Anderson Cancer Center, Houston, Texas 77030, United States
Mid-West Children's Cancer Center, Milwaukee, Wisconsin 53226-4801, United States
Additional Information
St. Jude Children's Research Hospital
Starting date: March 2005
Last updated: October 5, 2011
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