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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00186940
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 25, 2017
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Brief 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.

Condition or disease Intervention/treatment
Leukemia Lymphoma Tumor Lysis Syndrome Hyperuricemia Drug: Rasburicase

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.

Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Study of Rasburicase Treatment for Chemotherapy of Malignancy-Induced Hyperuricemia in Patients With a History of Asthma Allergies
Study Start Date : March 2005
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Asthma
Drug Information available for: Rasburicase

Group/Cohort Intervention/treatment
1 Drug: Rasburicase
Rasburicase 0.2 mg/kg/dose by the intravenous route for up to 7 days.

Primary Outcome Measures :
  1. Incidence of grade 3 or 4 allergic reactions [ Time Frame: Within 30 days of last treatment administration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at high risk of tumor lysis syndrome who have a history of asthma, eczema, or significant allergies (to substances other than rasburicase).

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00186940

United States, California
Stanford University
Palo Alto, California, United States, 94304
Rady Children's Hospital
San Diego, California, United States, 92123
United States, Indiana
Peyton Manning Children's Hospital at St. Vincent
Indianapolis, Indiana, United States, 46260
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115-6084
United States, Michigan
Children's Hospital Michigan
Detroit, Michigan, United States, 48201
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Tennessee
St.Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Wisconsin
Mid-West Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226-4801
Sponsors and Collaborators
St. Jude Children's Research Hospital
Principal Investigator: Raul C. Ribeiro, MD St. Jude Children's Research Hospital

Additional Information:
Responsible Party: St. Jude Children's Research Hospital Identifier: NCT00186940     History of Changes
Other Study ID Numbers: RASALL
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: October 2011

Keywords provided by St. Jude Children's Research Hospital:

Additional relevant MeSH terms:
Tumor Lysis Syndrome
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gout Suppressants
Antirheumatic Agents