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

Information source: St. Jude Children's Research Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leukemia; Lymphoma; Tumor Lysis Syndrome; Hyperuricemia

Intervention: Rasburicase (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: St. Jude Children's Research Hospital

Official(s) and/or principal investigator(s):
Raul C. Ribeiro, MD, Principal Investigator, Affiliation: St. Jude Children's Research Hospital

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.

Clinical Details

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

Study design: Time Perspective: Prospective

Primary outcome: Incidence of grade 3 or 4 allergic reactions

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Stanford University, Palo Alto, California 94304, United States

Rady Children's Hospital, San Diego, California 92123, United States

Peyton Manning Children's Hospital at St. Vincent, Indianapolis, Indiana 46260, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115-6084, United States

Children's Hospital Michigan, Detroit, Michigan 48201, United States

Columbia University Medical Center, New York, New York 10032, United States

Rhode Island Hospital, Providence, Rhode Island 02903, United States

St.Jude Children's Research Hospital, Memphis, Tennessee 38105, United States

Cook Children's Medical Center, Fort Worth, Texas 76104, United States

MD Anderson Cancer Center, Houston, Texas 77030, United States

Mid-West Children's Cancer Center, Milwaukee, Wisconsin 53226-4801, United States

Additional Information

St. Jude Children's Research Hospital

Starting date: March 2005
Last updated: October 5, 2011

Page last updated: August 20, 2015

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