Back to resultsFasturtec TLS Treatment / Prophylysis
Primary Purpose
Tumor Lysis Syndrome
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
urate oxidase
Sponsored by
About this trial
This is an interventional treatment trial for Tumor Lysis Syndrome
Eligibility 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
Sites / Locations
- Sanofi-Aventis
Outcomes
Primary Outcome Measures
To assess the uricolytic response to rasburicase treatment
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00651911
Brief Title
Fasturtec TLS Treatment / Prophylysis
Official Title
A Multicenter Open Label Study of the Efficacy and Safety of Rasburicase in the Treatment of Prophylysis for Tumor Lysis Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
An open-label study to determine the efficacy and safety of Rasburicase used for the prevention and treatment of tumor lysis syndrome
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor Lysis Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
urate oxidase
Other Intervention Name(s)
rasburicase
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Chang
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Fasturtec TLS Treatment / Prophylysis
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