EFC4978 Evaluation of Single Agent Raburicase for 5 Days Versus Sequential Treatment with Rasburicase from Day 1 Through 3 Followed by Oral Allopurinol from Day 3 Through 5 (Overlap on Day 3) Versus Single Agent Oral Allopurinol for 5 Days in the Management of Plasma Uric Acid in Adult Patients with Leukemia, Lymphoma, and Solid Tumor Malignancies at Risk for Hyperuricemia and Tumor Lysis Syndrome

Principal Investigator: Jeffrey V. Matous, MD

Protocol Number: RMBMT-119

Major Objectives

Patient Selection

Inclusion Criteria:

1. Patients at high risk or potential risk for TLS.
2. ECOG performance status 0-3
3. Life expectancy >3 months
4. Age ≥ 18 years
5. Negative pregnancy test ≤ 2 weeks (females of child bearing potential) and use of effective contraceptive method (both males and females).
6. Signed written consent obtained prior to study entry.

Exclusion Criteria:

1. History of established diagnosis of asthma; or of severe, life-threatening, atopic allergy
2. Hypersensitivity to uricases or any of the excipients.
3. Known history of G6PD deficiency or history of hemolysis indicative of G6PD deficiency
4. Pregnant or lactating
5. Concomitant treatment with any investigational drug.
6. Patients with a prior history of uricolytic therapy (rasburicase or Uricozyme).
7. Patients with relapsed or refractory leukemia/lymphoma/solid tumors.
8. Unwilling or unable to comply with the requirements of the protocol.