Status:
COMPLETED
Pharmacokinetic Evaluation of Rasburicase in Patients With Leukemia and/or Lymphoma at High Risk of TLS
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Sanofi
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Primary 1\. To determine the pharmacokinetic (PK) parameters of rasburicase in adult patients with leukemia and/or lymphoma at high risk or potential risk of tumor lysis syndrome (TLS) Secondary 1....
Detailed Description
Rasburicase is designed to help decrease or prevent the high level of uric acid that may occur during the start of chemotherapy. A high level of uric acid may lead to reduced kidney function or kidney...
Eligibility Criteria
Inclusion
- Age \>/= 18
- Risk of TLS: A. High risk: hyperuricemia of malignancy; diagnosis of aggressive lymphoma/leukemia based on Revised European-American Lymphoma (REAL) classification; acute myeloid leukemia in blast crisis; high grade myelodysplastic syndrome only if they have \>10% bone marrow blast involvement and given aggressive treatment similar to AML; OR B. Potential risk: diagnosis of aggressive lymphoma/leukemia based on (REAL) classification. Plus one or more of the following criteria: LDH \>/=2 x ULN; Stage III-IV disease; Stage I-II disease with at least 1 lymph node/tumor \>5cm in diameter.
- ECOG performance status 0-3
- Life expectancy \>3 months
- Negative pregnancy test (females of child bearing potential) within \</=2 weeks of rasburicase dose and use of efficient contraceptive method (both males and females). Pregnancy test may be performed on serum (HCG) or urine (HCG)
- Signed written informed consent (approved by the Institutional Review Board/Ethics Committee) obtained prior to study entry
Exclusion
- Patient receiving any investigational drug for hyperuricemia within 30 days of planned first treatment with rasburicase
- Pregnancy or lactation
- Known history of significant allergy problem or documented history of asthma or asthmatic bronchitis
- Known history of glucose-6-phosphate dehydrogenase deficiency
- Known history of hemolysis and methemoglobinemia
- Positive tests for HBs antigen, HCV antibodies, or HIV-1, 2 antibodies
- Hypersensitivity to uricases or any of the excipients
- Previous therapy with urate oxidase
- Other conditions unsuitable for participation in the trial in the Investigator's opinion
- Unwilling to comply with the requirements of the protocol
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00360438
Start Date
July 1 2006
End Date
April 1 2007
Last Update
August 1 2012
Active Locations (1)
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1
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030