Rasburicase in Patients at Risk for Tumor Lysis Syndrome
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ClinicalTrials.gov Identifier: NCT00628628 |
Recruitment Status
:
Completed
First Posted
: March 5, 2008
Results First Posted
: August 1, 2013
Last Update Posted
: August 1, 2013
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Tracking Information | ||||
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First Submitted Date ICMJE | February 25, 2008 | |||
First Posted Date ICMJE | March 5, 2008 | |||
Results First Submitted Date | May 31, 2013 | |||
Results First Posted Date | August 1, 2013 | |||
Last Update Posted Date | August 1, 2013 | |||
Study Start Date ICMJE | January 2008 | |||
Actual Primary Completion Date | May 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Number of Participants With Plasma Uric Acid (UA) Response [ Time Frame: First cycle of chemotherapy, up to 5 days ] Plasma UA response is defined as normalization of plasma UA levels within 48 hours after the start of study drug (rasburicase) and maintaining within the normal range after the final drug infusion on day 5. Plasma samples for UA were collected at baseline before rasburicase, 4- and 24-hours post-rasburicase, and daily during treatment.
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Original Primary Outcome Measures ICMJE |
The goal of this clinical research study is to compare how well rasburicase given in 2 different ways can help control or prevent TLS in patients who are at risk for TLS. [ Time Frame: 17 Months ] | |||
Change History | Complete list of historical versions of study NCT00628628 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE |
The safety of this treatment will also be studied. [ Time Frame: 17 Months ] | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Rasburicase in Patients at Risk for Tumor Lysis Syndrome | |||
Official Title ICMJE | Phase 2 Study of Rasburicase Administered by Two Different Schedules (Fixed Dosing vs. As Needed Dosing) in Patients at High Risk or Potential Risk for Tumor Lysis Syndrome | |||
Brief Summary | Primary Objectives: To determine the efficacy of rasburicase administered as a single dose followed by as needed dosing (investigational arm) as compared to fixed dosing for 5 days (standard treatment arm) in the treatment of patients at high risk or potential risk for tumor lysis syndrome. Secondary Objectives:
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Detailed Description | The Study Drug and TLS Rasburicase is designed to help decrease or prevent the high level of uric acid that may occur during the start of chemotherapy. A high level of uric acid in the blood may lead to decreased kidney function or kidney failure. TLS occurs when high uric acid levels are caused by breakdown of tumor cells during the start of chemotherapy. The dead tumor cells can release uric acid and cause other symptoms of kidney failure, such as releasing large amounts of potassium and phosphorus (chemicals) into the blood. Screening Tests Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your complete medical history will be recorded. You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate), height, and weight. Blood will be drawn (about 2 tablespoons) for routine tests. Women who are able to have children must have a negative blood (using a sample from the routine blood draw) or urine pregnancy test. Study Groups If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1 of 2 groups. There is an equal chance of being in either group. Group A Participants in Group A will receive rasburicase by vein, over 30 minutes, on Day 1 of Cycle 1 of chemotherapy. On Days 1-7 of Cycle 1 of chemotherapy, blood (about 2 tablespoons) will be drawn for routine tests, including a check of the level of uric acid in your blood. During Days 2-5 of Cycle 1 of chemotherapy, you will only receive rasburicase (once a day) if the levels of uric acid are high that day. Group B Participants in Group B will receive rasburicase by vein, over 30 minutes, once a day from Days 1-5 of Cycle 1 of chemotherapy. On Days 1-7 of Cycle 1 of chemotherapy, blood (about 2 tablespoons) will be drawn for routine tests, including a check of the level of uric acid in your blood. Both Groups Treatment with rasburicase will only be given in Cycle 1 of chemotherapy. The chemotherapy will be given at least 4 hours (up to 24 hours) after the first dose of rasburicase. Length of Study When your blood test results show that you do not have antibodies to rasburicase, your participation in this study will be over. You will be taken off this study if the TLS gets worse or intolerable side effects occur. This is an investigational study. Rasburicase is commercially available, but it is not FDA approved for treating TLS. It is FDA approved for pediatric patients with leukemia, lymphoma, and solid tumor cancers who are receiving anti-cancer therapy that is expected to increase the blood levels of uric acid (the result of cancer cells dying from treatment). For treating TLS in adult patients, it has been authorized for use in research only. Up to 80 evaluable patients will take part in this study. All will be enrolled at M. D. Anderson. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Tumor Lysis Syndrome | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Vadhan-Raj S, Fayad LE, Fanale MA, Pro B, Rodriguez A, Hagemeister FB, Bueso-Ramos CE, Zhou X, McLaughlin PW, Fowler N, Shah J, Orlowski RZ, Samaniego F, Wang M, Cortes JE, Younes A, Kwak LW, Sarlis NJ, Romaguera JE. A randomized trial of a single-dose rasburicase versus five-daily doses in patients at risk for tumor lysis syndrome. Ann Oncol. 2012 Jun;23(6):1640-5. doi: 10.1093/annonc/mdr490. Epub 2011 Oct 19. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
82 | |||
Original Estimated Enrollment ICMJE |
65 | |||
Actual Study Completion Date | May 2012 | |||
Actual Primary Completion Date | May 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Senior | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00628628 | |||
Other Study ID Numbers ICMJE | 2006-0918 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | M.D. Anderson Cancer Center | |||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | |||
Collaborators ICMJE | Sanofi | |||
Investigators ICMJE |
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PRS Account | M.D. Anderson Cancer Center | |||
Verification Date | May 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |