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

NCT ID: NCT00186940

Last Updated: 2017-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2010-02-28

Brief Summary

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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

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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.

Conditions

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Leukemia Lymphoma Tumor Lysis Syndrome Hyperuricemia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Rasburicase

Intervention Type DRUG

Rasburicase 0.2 mg/kg/dose by the intravenous route for up to 7 days.

Interventions

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Rasburicase

Rasburicase 0.2 mg/kg/dose by the intravenous route for up to 7 days.

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

St. Jude Children's Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raul C. Ribeiro, MD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

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Stanford University

Palo Alto, California, United States

Site Status

Rady Children's Hospital

San Diego, California, United States

Site Status

Peyton Manning Children's Hospital at St. Vincent

Indianapolis, Indiana, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Children's Hospital Michigan

Detroit, Michigan, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

St.Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status

Cook Children's Medical Center

Fort Worth, Texas, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Mid-West Children's Cancer Center

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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http://www.stjude.org

St. Jude Children's Research Hospital

Other Identifiers

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RASALL

Identifier Type: -

Identifier Source: org_study_id

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