ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy Patients

This study is currently recruiting participants.
Verified by St. Jude Children's Research Hospital, June 2008

Sponsors and Collaborators: St. Jude Children's Research Hospital
Sanofi-Aventis
Information provided by: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00186940
  Purpose

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 Intervention Phase
Leukemia
Lymphoma
Tumor Lysis Syndrome
Hyperuricemia
Drug: Rasburicase
Phase IV

MedlinePlus related topics:   Allergy    Asthma    Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma   

ChemIDplus related topics:   Rasburicase   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:   A Study of Rasburicase Treatment for Chemotherapy of Malignancy-Induced Hyperuricemia in Patients With a History of Asthma Allergies

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Incidence of grade 3 or 4 allergic reactions [ Time Frame: Within 30 days of last treatment administration ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   72
Study Start Date:   March 2005
Estimated Study Completion Date:   December 2008
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

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

Detailed Description:

ecause 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.

  Eligibility
Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patient is less than or equal to 21 years of age
  • Patient has a diagnosis of hematologic malignancy
  • Patient has hyperuricemia or is at high risk of developing hyperuricemia of malignancy
  • Patient has a history of asthma or significant allergy
  • No prior exposure to rasburicase or other urate oxidase

Exclusion Criteria

  • Pregnancy or lactation
  • Wheezing or an active hypersensitivity reaction at entry
  • Hypersensitivity to Aspergillus proteins
  • Significant airway compression
  • Known history of G6PD deficiency
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00186940

Contacts
Contact: Raul C Ribeiro, MD     1-866-278-5833     info@stjude.org    

Locations
United States, California
Stanford University     Recruiting
      Palo Alto, California, United States, 94304
United States, Maine
Maine Medical Center     Recruiting
      Portland, Maine, United States, 04102
United States, Massachusetts
Dana-Farber Cancer Institute     Recruiting
      Boston, Massachusetts, United States, 02115-6084
United States, Michigan
Children's Hospital Michigan     Recruiting
      Detroit, Michigan, United States, 48201
United States, Tennessee
St.Jude Children's Research Hospital     Recruiting
      Memphis, Tennessee, United States, 38105
      Contact: Raul C Ribeiro, MD     866-278-5833     info@stjude.org    
      Principal Investigator: Raul C Ribeiro, MD            
United States, Texas
Cook Children's Medical Center     Recruiting
      Fort Worth, Texas, United States, 76104
MD Anderson Cancer Center     Recruiting
      Houston, Texas, United States, 77030
United States, Wisconsin
Mid-West Children's Cancer Center     Recruiting
      Milwaukee, Wisconsin, United States, 53226-4801

Sponsors and Collaborators
St. Jude Children's Research Hospital
Sanofi-Aventis

Investigators
Principal Investigator:     Raul C Ribeiro, MD     St. Jude Children's Research Hospital    
  More Information


St. Jude Children's Research Hospital  This link exits the ClinicalTrials.gov site
 

Responsible Party:   St. Jude Children's Research Hospital ( Raul C. Ribeiro, Principal Investigator )
Study ID Numbers:   RASALL
First Received:   September 12, 2005
Last Updated:   June 2, 2008
ClinicalTrials.gov Identifier:   NCT00186940
Health Authority:   United States: Institutional Review Board

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

Study placed in the following topic categories:
Lymphatic Diseases
Leukemia
Hypersensitivity
Immunoproliferative Disorders
Hypersensitivity, Immediate
Hyperuricemia
Asthma
Tumor Lysis Syndrome
Lymphoproliferative Disorders
Rasburicase
Lymphoma

Additional relevant MeSH terms:
Neoplasms
Pathologic Processes
Disease
Neoplasms by Histologic Type
Immune System Diseases
Therapeutic Uses
Syndrome
Antirheumatic Agents
Gout Suppressants
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 15, 2008




Links to all studies - primarily for crawlers