A Randomized Phase 2 Study to Evaluate the Efficacy of Rasburicase in Patients at Risk for TLS During Two Cycles of Chemotherapy
Rasburicase is designed to help decrease or prevent the high level of uric acid that may
occur during the beginning of chemotherapy. A high level of uric acid results from TLS and
can lead to kidney failure.
Allopurinol is designed to help block uric acid. It is the standard of care for helping to
control increased uric acid levels caused by TLS.
Study Groups and Drug Administration:
Each cycle will last about 3 weeks.
If you are found to be eligible to take part in this study, you will receive rasburicase by
vein over about 30 minutes on Day 1 of Cycle 1 (about 4 hours before you begin receiving
chemotherapy). If the doctor thinks it is needed, you may also receive the drug on Days 2-5
of Cycle 1.
For Cycle 2, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study
groups. There is an equal chance of being assigned to either group:
- If you are in Group A, you will receive rasburicase on Day 1 of Cycle 2. If the doctor
thinks it is needed, you may also receive the drug on Days 2-5 of Cycle 2.
- If you are in Group B, you will receive allopurinol by vein over 30 minutes each day on
Days 1-5 of Cycle 2.
Group B Participants: If your uric acid blood levels continue to increase in Cycle 2 and you
show symptoms of tumor lysis syndrome, you may receive rasburicase as a single dose. If the
doctor thinks it is needed, you may also receive 1 or more additional dose(s).
On Day 1 of Cycle 1:
- Blood (about 1 teaspoon) will be drawn to check uric acid levels before and 4 hours
after you receive rasburicase.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- Blood (about 1 teaspoon) will be drawn for antibody testing. Antibodies are proteins
made by the body that the immune system uses to help prevent disease.
On Days 2-5 of Cycle 1:
- Blood (about 1 teaspoon) will be drawn to check uric acid levels.
- Blood (about 2 tablespoon) will be drawn for routine tests.
At the end of both cycles, blood (about 1 teaspoon) will be drawn for antibody testing.
Length of Study:
You will receive drugs on this study for up to 2 cycles. You will be taken off study if
intolerable side effects occur.
Your participation in the study will be over after the follow-up visit.
Three (3) months after the end of Cycle 2, blood (about 1 teaspoon) will be drawn for
This is an investigational study. Allopurinol is commercially available and FDA approved to
treat TLS. Rasburicase is commercially available and FDA approved for treating TLS for 1
cycle in patients with leukemia, lymphoma, and solid tumor cancers who are receiving
anti-cancer therapy. It is investigational to give rasburicase for 2 cycles.
Up to 55 patients will take part in this study. All will be enrolled at MD Anderson.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of Laboratory Tumor Lysis Syndrome (LTLS) during cycle-2
Number of patients (incidence) of LTLS in the two arms, as defined by the Cairo-Bishop criteria, during cycle 2.
Two 3-week cycles
Saroj Vadhan-Raj, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
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