Rasburicase in Patients at Risk for Tumor Lysis Syndrome

Completed · Phase 2

Conditions studied: Tumor Lysis Syndrome

In brief

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 treatment arm) in the treatment of patients at high risk or potential risk for tumor lysis syndrome. Secondary Objectives: 1. To evaluate the plasma uric acid area under the curve (AUC) from baseline through 7 days 2. To evaluate the incidence of renal insufficiency and electrolyte abnormalities. 3. To determine the safety and immunogenicity of rasburicase. 4. To evaluate the cost-effectiveness of the experimental treatment (investigational arm).

Key facts

Study ID

NCT00628628

Run by

M.D. Anderson Cancer Center

People needed

82

Starts

2008-01-01

Expected to finish

2012-05-01

Last updated by the study team

2013-08-01

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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