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

Sponsor:	St. Jude Children's Research Hospital
Collaborator:	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

Study Type:	Observational
Study Design:	Prospective
Official Title:	A Study of Rasburicase Treatment for Chemotherapy of Malignancy-Induced Hyperuricemia in Patients With a History of Asthma Allergies

Resource links provided by NLM:

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

Drug Information available for: Rasburicase

U.S. FDA Resources

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	72
Study Start Date:	March 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

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

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.

Eligibility

Genders Eligible for Study:	Both
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).

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.

Contacts and Locations

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

Locations

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

Sanofi-Aventis

Investigators

Principal Investigator:

Raul C. Ribeiro, MD

St. Jude Children's Research Hospital

More Information

Additional Information:

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

No publications provided

Responsible Party:	St. Jude Children's Research Hospital ( Raul C. Ribeiro, Principal Investigator )
Study ID Numbers:	RASALL
Study First Received:	September 12, 2005
Last Updated:	November 4, 2009
ClinicalTrials.gov Identifier:	NCT00186940 History of Changes
Health Authority:	United States: Institutional Review Board

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

leukemia

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Disease
Immune System Diseases
Hyperuricemia
Gout Suppressants
Rasburicase
Pharmacologic Actions
Leukemia

Lymphatic Diseases
Neoplasms
Pathologic Processes
Therapeutic Uses
Syndrome
Tumor Lysis Syndrome
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on November 25, 2009