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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00230217
Recruitment Status : Completed
First Posted : September 30, 2005
Last Update Posted : March 30, 2009
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tumors Hyperuricemia Tumor Lysis Syndrome Drug: Rasburicase (SR29142) Phase 4

Detailed Description:

This is a multi-center, 2 arm, open-label study;

  • Arm A: Patients previously treated with a uricolytic agent;
  • Arm B: Patients not previously treated with a uricolytic agent.

Patients receive rasburicase for 5 days and begin chemotherapy 4-24 hours after the first dose of rasburicase. Patients are followed at 14 and 35 days, at 3 and 6 months and every 6 months thereafter.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Single Agent Rasburicase in Treatment/Prevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Adult and Pediatric Patients With Lymphoma/Leukemia/Solid Tumor Malignancies at Their First Relapse or Refractory Disease
Study Start Date : March 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia Lymphoma
Drug Information available for: Rasburicase

Primary Outcome Measures :
  1. Positive response based on plasma uric acid levels. [ Time Frame: up to 48 hours after last administration. ]

Secondary Outcome Measures :
  1. safety assessment

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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
  2. Patients previously treated with a uricolytic agent or not at their first relapse or refractory disease
  3. 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.
  4. Life expectancy >3 months
  5. 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).
  6. Signed written informed consent

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00230217

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United States, California
Alta Bates Comprehensive Cancer Center
Berkley, California, United States, 94704
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, Florida
University of Florida Health Science Center at Jacksonville
Jacksonville, Florida, United States, 32209
United States, New York
New York Medical College
Valhalla, New York, United States, 10595
United States, Oklahoma
University of Oklahoma HSC
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania, United States, 19104
United States, West Virginia
Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States, 26506-9162
Sponsors and Collaborators
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Study Director: ICD CSD Sanofi
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Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00230217    
Obsolete Identifiers: NCT00086918, NCT00247767
Other Study ID Numbers: EFC5339
First Posted: September 30, 2005    Key Record Dates
Last Update Posted: March 30, 2009
Last Verified: March 2009
Keywords provided by Sanofi:
Solid Tumor
Additional relevant MeSH terms:
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Tumor Lysis Syndrome
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Gout Suppressants
Antirheumatic Agents