Clinical trial NCT01200485
Conditions: Leukemia Lymphoma
Keywords: Supportive Care Recombinant urate oxidase Chemotherapy Tumor Lysis Syndrome (TLS) Hematologic malignancies Acute myeloid leukemia
Sponsor: M.D. Anderson Cancer Center
Start date: 2011-04-01; Completion date: 2016-07-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if using Elitek (rasburicase) for 2 cycles can help to control or prevent TLS better than 1 cycle of rasburicase and 1 cycle of allopurinol. The safety of this treatment will also be studied.

Detailed description:
Study Drugs:

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).

Study Visits:

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.

Follow-Up:

Three (3) months after the end of Cycle 2, blood (about 1 teaspoon) will be drawn for antibody testing.

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.

Arms: arm 1: Rasburicase by vein on Day 1 (0.15 mg/kg or a flat dose of 3 mg) as a single dose, plus as needed dosing (until day 5), during cycle 1 (21 day cycle). arm 2: Participants randomized to Rasburicase (0.15 mg/kg) by vein on day 1 plus as needed dosing (until day 5) during Cycle 2. arm 3: Participants randomized to Allopurinol (300 mg/day) by vein each day on Days 1-5 of Cycle 2.
Interventions: intervention 1: Rasburicase intervention 2: Allopurinol
Intervention descriptions: intervention 1: Cycle 1: 3 mg/kg by vein on Day 1, plus as needed dosing (until day 5), during Cycle 1.

Cycle 2 Arm A: 0.15 mg/kg by vein on Day 1 of Cycle 2, plus as needed dosing (until day 5), during Cycle 2. intervention 2: Arm B: 300 mg/day by vein, as standard of care, over 30 minutes each day on days 1-5 of cycle 2 in 21 day cycle.

Protocol documents: