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Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome

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: NCT00230178
Recruitment Status : Completed
First Posted : September 30, 2005
Results First Posted : December 31, 2009
Last Update Posted : January 12, 2010
Information provided by:

Brief Summary:

This is a randomized, multi-center, open-label, parallel group study with three arms:

  • Rasburicase alone
  • Rasburicase followed by Allopurinol
  • Allopurinol alone

The primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms.

Condition or disease Intervention/treatment Phase
Tumor Lysis Syndrome Cancer Hyperuricemia Drug: Rasburicase (SR29142) Drug: Allopurinol Phase 3

Detailed Description:
After signing the informed consent and having met the inclusion criteria, patients will be randomized to 1 of the 3 arms and treated for a total duration of 5 days. Patients in all arms will receive chemotherapy beginning 4-24 hours after the first dose of rasburicase or allopurinol.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Single Agent Rasburicase for 5 Days Versus Sequential Treatment With Rasburicase From Day 1 Through 3 Followed by Oral Allopurinol From Day 3 Through 5 (Overlap on Day 3) Versus Single Agent Oral Allopurinol for 5 Days in the Management of Plasma Uric Acid in Adult Patients With Leukemia, Lymphoma, and Solid Tumor Malignancies at Risk for Hyperuricemia and Tumor Lysis Syndrome
Study Start Date : April 2004
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Arm Intervention/treatment
Experimental: Arm A
Rasburicase alone given as a single agent for 5 days
Drug: Rasburicase (SR29142)
30-min IV infusion

Experimental: Arm B
Rasburicase alone given as a single agent from Day 1 through Day 3, followed by oral allopurinol given from Day 3 through Day 5 (Day 3 is an overlap)
Drug: Rasburicase (SR29142)
30-min IV infusion

Drug: Allopurinol
Oral administration

Active Comparator: Arm C
Oral allopurinol alone given as a single agent for 5 days
Drug: Allopurinol
Oral administration

Primary Outcome Measures :
  1. Plasma Uric Acid Responder [ Time Frame: Day 3 through Day 7 ]
    Number of patients responding to treatment defined as plasma uric acid levels at Day 3 through Day 7 <7.5 mg/dl.

Secondary Outcome Measures :
  1. Plasma Uric Acid [ Time Frame: Day 1 to Day 7 ]
    Area under the curve concentration versus time curve extrapolated to infinity (AUC) of plasma uric acid values

  2. Time to Uric Acid Control [ Time Frame: Day 1 to Day 7 ]
    Time from the first dose of study drug to the time at which plasma uric acid concentrations were determined <=7.5 mg/dl, measured -4, 4, 24, 48, 72, 96, 120, and 144 hours after infusion.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Meets high risk or at potential risk 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 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, chronic myelomonocytic leukemia, and refractory anemia with excess blast in transformation) only if they have > 10% bone marrow blast involvement and are given aggressive treatment similar to AML.

    A patient is at potential risk for TLS if he/she presents with:

    • A diagnosis of 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 at least 1 lymph node/tumor > 5 cm in diameter

    In addition to the above-mentioned eligibility criteria, the patients should have the following criteria:

  2. Eastern Cooperative Oncology Group (ECOG) performance status 0-3
  3. Age >= 18 years
  4. Life expectancy > 3 months
  5. Negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (for both males and females). A pregnancy test may be performed on serum or urine human chorionic gonadotropin (HCG).
  6. Signed written informed consent

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): NCT00230178

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United States, California
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94704
UCLA Medical Center
Los Angeles, California, United States, 90095
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, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
New York Methodist Hospital
Brooklyn, New York, United States, 11215
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
University of Rochester Medical Center
Rochester, New York, United States, 14642
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oregon
Oregon Health and Sciences University
Portland, Oregon, United States, 97201
United States, Pennsylvania
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania, United States, 19194
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
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: International Clinical Development Sanofi
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Responsible Party: International Clinical Development, Clinical Study Director, sanofi-aventis Identifier: NCT00230178    
Other Study ID Numbers: EFC4978
First Posted: September 30, 2005    Key Record Dates
Results First Posted: December 31, 2009
Last Update Posted: January 12, 2010
Last Verified: January 2010
Keywords provided by Sanofi:
Tumor lysis syndrome
Myelodysplastic Syndromes
Solid tumor cancers
Solid Tumor cancers with hyperuricemia Hyperuricemia (cancer patients only)
Tumor lysis syndrome (cancer patients only)
Additional relevant MeSH terms:
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Tumor Lysis Syndrome
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Protective Agents
Physiological Effects of Drugs