Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy Patients



Status:Completed
Conditions:Cancer, Blood Cancer, Lymphoma, Leukemia
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:4/26/2017
Start Date:March 2005
End Date:February 2010

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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.

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.

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.
We found this trial at
11
sites
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Providence, RI
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3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Detroit, MI
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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Fort Worth, TX
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Houston, Texas 77030
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Houston, TX
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2001 West 86th Street
Indianapolis, Indiana 46260
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Indianapolis, IN
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262 Danny Thomas Place
Memphis, Tennessee 38105
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Memphis, TN
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9000 West Wisconsin Avenue
Milwaukee, Wisconsin 53226
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Milwaukee, WI
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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Palo Alto, California 94304
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Palo Alto, CA
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San Diego, California 92123
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San Diego, CA
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