Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies

• Status: Terminated
• Trial end date: 2016-05-28
• Target enrollment: 0
• Participant gender: All

Summary

This randomized phase II trial studies how well giving rasburicase together with allopurinol works in treating patients with hematologic malignancies. Rasburicase may reduce the level of uric acid in the blood. Allopurinol may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known which dose of rasburicase is more effective in treating hematologic malignancies when given together with or without allopurinol.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Allopurinol; Rasburicase

Criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) status of 0-3

• Active leukemia and Burkitt leukemia/lymphoma treated in-house that puts them at risk for tumor lysis syndrome (TLS)

• Serum uric acid level >= 7.5mg/dL and high risk for TLS as defined by:

• A diagnosis of acute myeloid leukemia (AML), or

• A diagnosis of blast-phase chronic myeloid leukemia (CML), or

• A diagnosis of high-grade myelodysplastic syndrome (MDS) with >= 10% blast bone marrow blast involvement, or

• Acute lymphoblastic leukemia (ALL), or

• Burkitt leukemia/lymphoma

• Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

• History of asthma

• History of severe or life threatening atopic allergy

• Hypersensitivity to uricases

• Known prior sensitivity to allopurinol

• Known glucose-6-phosphate dehydrogenase (G6PD) deficiency

• Recent prior history of uricolytic therapy defined as therapy within the last 7 days