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


Phase 4
N/A
N/A
Not Enrolling
Both
Leukemia, Lymphoma, Tumor Lysis Syndrome, Hyperuricemia

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Incidence of grade 3 or 4 allergic reactions

Outcome Time Frame:

Within 30 days of last treatment administration

Safety Issue:

Yes

Principal Investigator

Raul C. Ribeiro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

RASALL

NCT ID:

NCT00186940

Start Date:

March 2005

Completion Date:

February 2010

Related Keywords:

  • Leukemia
  • Lymphoma
  • Tumor Lysis Syndrome
  • Hyperuricemia
  • leukemia
  • Leukemia
  • Lymphoma
  • Tumor Lysis Syndrome
  • Hyperuricemia

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Rhode Island HospitalProvidence, Rhode Island  02903
Stanford UniversityStanford, California  94305
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Columbia University Medical CenterNew York, New York  10032
Cook Children's Medical CenterFort Worth, Texas  76104
St.Jude Children's Research HospitalMemphis, Tennessee  38105
Rady Children's HospitalSan Diego, California  92123
Peyton Manning Children's Hospital at St. VincentIndianapolis, Indiana  46260
Children's Hospital MichiganDetroit, Michigan  48201
Mid-West Children's Cancer CenterMilwaukee, Wisconsin  53226-4801