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Rasburicase in Patients at High Risk for Tumor Lysis Syndrome (TLS) During Cycle-2

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leukemia; Lymphoma

Intervention: Rasburicase (Drug); Allopurinol (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Saroj Vadhan-Raj, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Overall contact:
Saroj Vadhan-Raj, MD, Phone: 713-792-7966

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.

Clinical Details

Official title: A Randomized Phase 2 Study to Evaluate the Efficacy of Rasburicase in Patients at Risk for TLS During Two Cycles of Chemotherapy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of Laboratory Tumor Lysis Syndrome (LTLS) during cycle-2

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Patients that are high risk for TLS or potential/intermediate risk for TLS as described below: (a) High risk: Hyperuricemia of malignancy (Uric acid levels >7. 5); or diagnosis of very aggressive lymphoma/leukemia based on Revised European-American Lymphoma (REAL) classification; acute myeloid leukemia, CML in blast crisis; high grade myelodysplastic syndrome only if they have >10% bone marrow blast involvement and given aggressive treatment similar to acute myeloid leukemia (AML). (b) Potential risk: Diagnosis of aggressive lymphoma/leukemia based on (REAL) classification. Plus one or more of the following criteria: lactate dehydrogenase (LDH) >/= 2 x upper limit of normal (UNL); Stage III-IV disease; Stage I-II disease with at least 1 lymph node/tumor > 5 cm in diameter. For patients with potential/intermediate risk for TLS- Only those planned to receive alternating regimens (or non-standard regimens) in 2 cycles (example; R-Hyper-CVAD alternating with MTX/ARA-C) will be eligible. 2. ECOG performance status 0-3. 3. Negative pregnancy test (females of child bearing potential) within

Locations and Contacts

Saroj Vadhan-Raj, MD, Phone: 713-792-7966

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: April 2011
Last updated: March 9, 2015

Page last updated: August 23, 2015

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