Study of Rasburicase as Treatment or Prevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Patients With Relapsed or Refractory Lymphoma, Leukemia, or Solid Tumor Malignancy

Completed · Phase 4

Conditions studied: Tumors, Hyperuricemia, Tumor Lysis Syndrome

In brief

This is an open-label, multi-center study with 2 arms. The primary objective is to assess the response to treatment with rasburicase in 2 populations of adult and pediatric patients with lymphoma/leukemia/solid tumor malignancies, those previously treated with a uricolytic agent, and those not previously treated with a uricolytic agent at their first relapse or refractory disease.

Key facts

Study ID

NCT00230217

Run by

Sanofi

People needed

94

Starts

2004-03-01

Expected to finish

2006-07-01

Last updated by the study team

2009-03-30

Who can join

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

You may qualify if…

• Meets one of the following risk criteria for tumor lysis syndrome (TLS):
• A patient is at high risk for TLS if he/she presents with:
• Hyperuricemia of malignancy (plasma uric acid > 7.5 mg/dL);
• A diagnosis of a very aggressive lymphoma/leukemia based on the Revised European-American Lymphoma (REAL) classification of lymphoma/leukemia;
• Acute myeloid leukemia (AML);
• Chronic myeloid leukemia (CML) in blast crisis; or
• High grade myelodysplastic syndrome (refractory anemia with excess blast, refractory anemia with excess blast in transformation, or chronic myelomonocytic leukemia) only if they have > 10% bone marrow blast and are given aggressive treatment similar to AML
• A patient is at potential risk for TLS if he/she presents with:
• A diagnosis of an aggressive lymphoma/leukemia based on the REAL classification of lymphoma/leukemia plus 1 or more of the following criteria:
• Lactate dehydrogenase (LDH) > 2 x upper limit of normal (ULN)(IU/L)
• Stage III-IV disease
• Stage I-II disease with 1 lymph node/tumor > 5 cm in diameter
• Patients previously treated with a uricolytic agent or not at their first relapse or refractory disease
• Eastern Cooperative Oncology Group (ECOG) performance status 0-3. ECOG equivalent derived from Karnofsky performance scale 100-30 or Lansky performance score 100-30 (patients < or = 16 years of age) may also be used.
• Life expectancy >3 months
• Negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (both males and females). A pregnancy test may be performed on serum or urine human chorionic gonadotropin (HCG).
• Signed written informed consent

You may not qualify if…

• History of established diagnosis of asthma or severe life-threatening atopic allergy
• Hypersensitivity to uricases or any of the excipients
• Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or history of hemolysis indicative of G6PD deficiency
• Pregnant or lactating
• Concomitant treatment with any investigational drug
• Planned treatment with rituximab
• Receipt of rituximab within the 12 month period prior to study entry
• Unwilling or unable to comply with the requirements of the protocol

Where it is running

• Alta Bates Comprehensive Cancer Center — Berkley, California, United States
• Rocky Mountain Cancer Center — Denver, Colorado, United States
• University of Florida Health Science Center at Jacksonville — Jacksonville, Florida, United States
• New York Medical College — Valhalla, New York, United States
• University of Oklahoma HSC — Oklahoma City, Oklahoma, United States
• University of Pennsylvania Health Systems — Philadelphia, Pennsylvania, United States
• Mary Babb Randolph Cancer Center — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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