Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies
Condition: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Blastic Phase Chronic Myelogenous Leukemia; Contiguous Stage II Adult Burkitt Lymphoma; de Novo Myelodysplastic Syndromes; Noncontiguous Stage II Adult Burkitt Lymphoma; Previously Treated Myelodysplastic Syndromes; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; Recurrent Adult Burkitt Lymphoma; Stage I Adult Burkitt Lymphoma; Stage III Adult Burkitt Lymphoma; Stage IV Adult Burkitt Lymphoma; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Adult Acute Myeloid Leukemia
MeSH terms: Burkitt Lymphoma; Lymphoma; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Blast Crisis; Myelodysplastic Syndromes; Syndrome; Recurrence
Intervention: rasburicase; allopurinol
Intervention description: Given IV; Given PO
Intervention MeSH terms: Allopurinol; Rasburicase
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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