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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00186940
Other study ID # RASALL
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated April 24, 2017
Start date March 2005
Est. completion date February 2010

Study information

Verified date October 2011
Source St. Jude Children's Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 16
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Children's Hospital Michigan Detroit Michigan
United States Cook Children's Medical Center Fort Worth Texas
United States MD Anderson Cancer Center Houston Texas
United States Peyton Manning Children's Hospital at St. Vincent Indianapolis Indiana
United States St.Jude Children's Research Hospital Memphis Tennessee
United States Mid-West Children's Cancer Center Milwaukee Wisconsin
United States Columbia University Medical Center New York New York
United States Stanford University Palo Alto California
United States Rhode Island Hospital Providence Rhode Island
United States Rady Children's Hospital San Diego California

Sponsors (2)

Lead Sponsor Collaborator
St. Jude Children's Research Hospital Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of grade 3 or 4 allergic reactions Within 30 days of last treatment administration
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