Rasburicase in Patients at High Risk for Tumor Lysis Syndrome (TLS) During Cycle-2
Condition: Leukemia; Lymphoma
MeSH terms: Tumor Lysis Syndrome
Intervention: Rasburicase; Allopurinol
Intervention description: 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.; 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.
Intervention MeSH terms: Allopurinol; Rasburicase
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Healthy volunteers: No
Keywords: Supportive Care; Recombinant urate oxidase; Chemotherapy; Tumor Lysis Syndrome (TLS); Hematologic malignancies; Acute myeloid leukemia

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.
    

Eligibility 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-central venous access device (CVAD) alternating with
             MTX/ARA-C) will be eligible.

          2. Eastern Cooperative Oncology Group (ECOG) performance status 0-3.

          3. Negative pregnancy test (females of child bearing potential) within </= 1 week of
             rasburicase dose and use of efficient contraceptive method (both males and females).
             Pregnancy test may be performed on serum (HCG) or urine (HCG).

          4. Signed written informed consent approved by the Institutional Review Board obtained
             prior to study entry.

        Exclusion Criteria:

          1. Prior H/O severe allergy or asthma requiring active treatment.

          2. Patients with mantle cell lymphoma (MCL) with stage 1 or 2 disease.

          3. Patient receiving any investigational drug for hyperuricemia within 30 days of planned
             first treatment with rasburicase.

          4. Pregnancy or lactation.

          5. Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency.

          6. Known history of hemolysis and/or methemoglobinemia.

          7. Previous therapy with urate oxidase.

          8. Conditions unsuitable for participation in the trial in the Investigator's opinion.

          9. Unwillingness to comply with the requirements of the protocol.

         10. Use of allopurinol within 72 hours of the study entry.