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

This study is currently recruiting participants.
Study NCT00186940.   Last updated on December 1, 2008.   Information provided by St. Jude Children's Research Hospital

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Descriptive Information Fields
Brief Title  Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy Patients
Official Title  A Study of Rasburicase Treatment for Chemotherapy of Malignancy-Induced Hyperuricemia in Patients With a History of Asthma Allergies
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.

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 Phase Phase IV
Study Type  Interventional
Study Design  Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary Outcome Measure  Incidence of grade 3 or 4 allergic reactions [ Time Frame: Within 30 days of last treatment administration ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure 
Condition  Leukemia
Lymphoma
Tumor Lysis Syndrome
Hyperuricemia
Intervention  Drug: Rasburicase
MEDLINE PMIDs
Links St. Jude Children's Research Hospital This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  72
Start Date  March 2005
Completion Date December 2008
Eligibility Criteria 

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
Gender Both
Ages
Accepts Healthy Volunteers No
Contacts ††
Contact: Raul C Ribeiro, MD     1-866-278-5833     info@stjude.org    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00186940
Organization ID RASALL
Secondary IDs ††
Study Sponsor  St. Jude Children's Research Hospital
Collaborators †† Sanofi-Aventis
Investigators 
Principal Investigator:     Raul C Ribeiro, MD     St. Jude Children's Research Hospital    
Information Provided By St. Jude Children's Research Hospital
Verification Date December 2008
First Received Date  September 12, 2005
Last Updated Date December 1, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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