Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome
Tumor Lysis Syndrome, Cancer, Hyperuricemia
About this trial
This is an interventional prevention trial for Tumor Lysis Syndrome focused on measuring Hyperuricemia, Tumor lysis syndrome, Leukemia, Lymphoma, Myelodysplastic Syndromes, Solid tumor cancers, Solid Tumor cancers with hyperuricemia Hyperuricemia (cancer patients only), Tumor lysis syndrome (cancer patients only)
Eligibility Criteria
Inclusion Criteria: Meets high risk or at potential risk for tumor lysis syndrome (TLS): A patient is at high risk for TLS if he/she presents with: Hyperuricemia of malignancy (plasma uric acid > 7.5 mg/dL); A diagnosis of very aggressive lymphoma/leukemia based on the Revised European-American Lymphoma (REAL) classification of lymphoma/leukemia; Acute myeloid leukemia (AML); Chronic myeloid leukemia (CML) in blast crisis; or High grade myelodysplastic syndrome (refractory anemia with excess blast, chronic myelomonocytic leukemia, and refractory anemia with excess blast in transformation) only if they have > 10% bone marrow blast involvement and are given aggressive treatment similar to AML. A patient is at potential risk for TLS if he/she presents with: A diagnosis of aggressive lymphoma/leukemia based on the REAL classification of lymphoma/leukemia plus 1 or more of the following criteria: Lactate dehydrogenase (LDH) >= 2 x upper limit of normal (ULN) (IU/L) Stage III-IV disease Stage I-II disease with at least 1 lymph node/tumor > 5 cm in diameter In addition to the above-mentioned eligibility criteria, the patients should have the following criteria: Eastern Cooperative Oncology Group (ECOG) performance status 0-3 Age >= 18 years Life expectancy > 3 months Negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (for both males and females). A pregnancy test may be performed on serum or urine human chorionic gonadotropin (HCG). Signed written informed consent
Sites / Locations
- Alta Bates Comprehensive Cancer Center
- UCLA Medical Center
- Rocky Mountain Cancer Center
- University of Florida Health Science Center at Jacksonville
- Ochsner Clinic Foundation
- Massachusetts General Hospital
- New York Methodist Hospital
- Roswell Park Cancer Institute
- University of Rochester Medical Center
- New York Medical College
- Duke University Medical Center
- Oregon Health and Sciences University
- University of Pennsylvania Health Systems
- University of Texas MD Anderson Cancer Center
- Mary Babb Randolph Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Arm A
Arm B
Arm C
Rasburicase alone given as a single agent for 5 days
Rasburicase alone given as a single agent from Day 1 through Day 3, followed by oral allopurinol given from Day 3 through Day 5 (Day 3 is an overlap)
Oral allopurinol alone given as a single agent for 5 days