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Fasturtec TLS Treatment / Prophylysis

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ClinicalTrials.gov Identifier: NCT00651911
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : April 3, 2008
Sponsor:
Information provided by:
Sanofi

Brief Summary:
An open-label study to determine the efficacy and safety of Rasburicase used for the prevention and treatment of tumor lysis syndrome

Condition or disease Intervention/treatment Phase
Tumor Lysis Syndrome Drug: urate oxidase Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Open Label Study of the Efficacy and Safety of Rasburicase in the Treatment of Prophylysis for Tumor Lysis Syndrome
Study Start Date : July 2003
Actual Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Rasburicase
U.S. FDA Resources


Intervention Details:
    Drug: urate oxidase
    First injection of Rasburicase will be done the day of initiation of chemotherapy, or the day before, according to hyperuricemia. Additional doses are permitted q12h during the first 72 hours of chemotherapy if hyperuricemia persists or subject is considered to be at significant risk of tumor lysis complications.
    Other Name: rasburicase


Primary Outcome Measures :
  1. To assess the uricolytic response to rasburicase treatment [ Time Frame: 5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection) ]

Secondary Outcome Measures :
  1. To evaluate tumor lysis risk factors, treatments for tumor lysis syndrome and complications of treatment in patients treated prophylactically or therapeutically for tumor lysis syndrome [ Time Frame: 5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection) ]


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

Inclusion Criteria:

  • Chemotherapy planned for at least 3 cycles
  • Undergoing cytoreductive chemotherapy for ALL, multiple myeloma or Burkitt's lymphoma stage III or IV
  • With a minimum life expectancy of 3 months
  • Uric acid > 8 mg%
  • Negative pregnancy test < or =to 2 weeks and efficient contraceptive method.
  • Negative HIV serology < or =to 4 weeks
  • Patient or legal guardian has signed a written informed consent

Exclusion Criteria:

  • Hypersensitivity to uricases or any of the excipients
  • Known history of G6PD deficiency.
  • Previous treatment with Rasburicase or Uricozyme®
  • Pregnancy or lactation
  • Treatment with any investigational drug within 30 days before planned first Rasburicase administration

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 ClinicalTrials.gov identifier (NCT number): NCT00651911


Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Sharon Chang Sanofi

Responsible Party: Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00651911     History of Changes
Other Study ID Numbers: L_8637
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: April 3, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Syndrome
Tumor Lysis Syndrome
Disease
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rasburicase
Gout Suppressants
Antirheumatic Agents