Status:
COMPLETED
Rasburicase in Patients at Risk for Tumor Lysis Syndrome
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Sanofi
Conditions:
Tumor Lysis Syndrome
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
Primary Objectives: To determine the efficacy of rasburicase administered as a single dose followed by as needed dosing (investigational arm) as compared to fixed dosing for 5 days (standard treatmen...
Detailed Description
The Study Drug and TLS 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 in the blood may lead ...
Eligibility Criteria
Inclusion
- Patients with hematological malignancies (leukemia/lymphoma) at high risk or potential risk for tumor lysis syndrome. High risk: hyperuricemia of malignancy (Uric acid levels \>7.5); diagnosis of very aggressive lymphoma/leukemia based on Revised European-American Lymphoma (REAL) classification; acute myeloid leukemia, chronic myelocytic leukemia (CML) in blast crisis; high grade myelodysplastic syndrome only if they have \>10% bone marrow blast involvement and given aggressive treatment similar to acute myeloid leukemia (AML) (continued on #2)
- (continued from # 1) Potential risk: diagnosis of aggressive lymphoma/leukemia based on (REAL) classification. Plus one or more of the following criteria: lactate dehydrogenase (LDH) \>/= 2 x upper limit of normal (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
- Previous therapy with urate oxidase
- Other conditions unsuitable for participation in the trial in the Investigator's opinion
- Unwillingness to comply with the requirements of the protocol
- Use of allopurinol within 72 hours of the study entry
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00628628
Start Date
January 1 2008
End Date
May 1 2012
Last Update
August 1 2013
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030