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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00230178
First received: September 28, 2005
Last updated: January 8, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Tumor Lysis Syndrome
Cancer
Hyperuricemia
Drug: Rasburicase (SR29142)
Drug: Allopurinol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Plasma Uric Acid Responder [ Time Frame: Day 3 through Day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma Uric Acid [ Time Frame: Day 1 to Day 7 ] [ Designated as safety issue: No ]
  • Time to Uric Acid Control [ Time Frame: Day 1 to Day 7 ] [ Designated as safety issue: No ]

Enrollment: 280
Study Start Date: April 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230178

Locations
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
Sanofi
Investigators
Study Director: International Clinical Development Sanofi
  More Information

No publications provided

Responsible Party: International Clinical Development, Clinical Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00230178     History of Changes
Other Study ID Numbers: EFC4978
Study First Received: September 28, 2005
Results First Received: July 22, 2009
Last Updated: January 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Hyperuricemia
Tumor lysis syndrome
Leukemia
Lymphoma
Myelodysplastic Syndromes
Solid tumor cancers
Solid Tumor cancers with hyperuricemia Hyperuricemia (cancer patients only)
Tumor lysis syndrome (cancer patients only)

Additional relevant MeSH terms:
Tumor Lysis Syndrome
Hyperuricemia
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Allopurinol
Rasburicase
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Antimetabolites
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014