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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00230217
First received: September 28, 2005
Last updated: March 27, 2009
Last verified: March 2009
  Purpose

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 Intervention Phase
Tumors
Hyperuricemia
Tumor Lysis Syndrome
Drug: Rasburicase (SR29142)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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

Secondary Outcome Measures:
  • safety assessment

Enrollment: 94
Study Start Date: March 2004
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00230217

Locations
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
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00230217     History of Changes
Obsolete Identifiers: NCT00086918, NCT00247767
Other Study ID Numbers: EFC5339
Study First Received: September 28, 2005
Last Updated: March 27, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Relapse
Refracturing
Leukemia
Lymphoma
Solid Tumor

Additional relevant MeSH terms:
Leukemia
Lymphoma
Tumor Lysis Syndrome
Hyperuricemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Rasburicase
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014