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

Lymphoma Clinical Trial

Official title:

A Study of Rasburicase Treatment for Chemotherapy of Malignancy-Induced Hyperuricemia in Patients With a History of Asthma Allergies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00186940
• Other study ID #: RASALL
• 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
• 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.

Related Conditions & MeSH terms

• Hyperuricemia
• Leukemia
• Lymphoma
• Tumor Lysis Syndrome

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

External Links

•   St. Jude Children's Research Hospital