EFC5339 Evaluation of Single Agent Rasburicase in Treatment/ Prevention Associated with Tumor Lysis Syndrome in Adult and Pediatric Patients with Lymphoma/Leukemia/Solid Tumor Malignancies at Their First Relapse or Refractory Disease

Principal Investigator: Jeffrey V. Matous, MD

Protocol Number: RMBMT-120

Major Objectives

Patient Selection

Inclusion Criteria:

• Patients at high risk or potential risk for TLS.
• Patients have been previously treated or not with a uricolytic agent, and are in their first relapse or refractory disease.
• ECOG performance status 0-3
• Life expectancy >3 months
• Negative pregnancy test
• Signed written consent obtained prior to study entry.

Exclusion Criteria:

• History of established diagnosis of asthma; or of severe, life-threatening, atopic allergy.
• Hypersensitivity to uricases or any of the excipients.
• Known history of G6PD deficiency or history of hemolysis indicative of G6PD deficiency.
• Pregnant or lactating
• Concomitant treatment with any investigational drug
• Planned treatment with rituximab
• Have received rituximab within the 12 months prior to study entry.
• Unwilling or unable to comply with the requirements of the protocol.