RATIONALE: Rasburicase is effective in preventing or controlling high levels of uric acid in the blood and tumor lysis syndrome.

PURPOSE: This phase IV trial is studying how well rasburicase works in treating or preventing high levels of uric acid in the blood and tumor lysis syndrome in patients who are receiving chemotherapy for relapsed or refractory lymphoma, leukemia, or solid tumors.

Condition	Intervention	Phase
Cancer hyperuricemia Tumor Lysis Syndrome	Drug: rasburicase  Procedure: chemoprotection  Procedure: complications of therapy assessment/management  Procedure: renal complications management  Procedure: supportive care/therapy	Phase IV

Further Study Details: 

OBJECTIVES:

Primary

• Determine response in patients with relapsed or refractory lymphoma, leukemia, or malignancy previously treated or not treated with rasburicase as treatment or prevention of hyperuricemia and tumor lysis syndrome.
• Determine response to this drug in these patients.

Secondary

• Determine the safety of this drug in these patients.
• Determine the plasma uric acid AUC in patients treated with this drug.
• Determine the incidence, duration, and type of immune responses (immunoglobulin [Ig] G, IgE, and neutralizing antibody) in patients treated with this drug.
• Determine the efficacy and safety of this drug, in relation to antibody generation and titer, in these patients.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to prior treatment with a uricolytic agent (yes vs no).

Patients receive rasburicase IV over 30 minutes on days 1-5 (or days 1-7). Treatment continues in the absence of unacceptable toxicity.

Patients receive cytoreductive chemotherapy off-study beginning 4-24 hours after the first dose of rasburicase.

Patients are followed at 14 days after the first dose of study treatment. After completion of study treatment, patients are followed at 30 days, at 3 and 6 months, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 170 patients (85 per stratum) will be accrued for this study within 18 months.

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Meets 1 of the following risk criteria for tumor lysis syndrome:
• At high-risk, with any of the following diagnoses:
• Hyperuricemia of malignancy (plasma uric acid > 7.5 mg/dL)
• Very aggressive lymphoma or leukemia in first relapse
• Acute myeloid leukemia
• Chronic myelogenous leukemia in blast crisis
• One of the following high-grade myelodysplastic syndromes AND ≥ 10% bone marrow blasts AND are undergoing aggressive chemotherapy:
• Refractory anemia with excess blasts [RAEB]
• RAEB in transformation
• Chronic myelomonocytic leukemia
• At potential-risk AND a diagnosis of an aggressive lymphoma or leukemia AND meets at least 1 of the following criteria:
• Lactic dehydrogenase ≥ 2 times upper limit of normal
• Stage III or IV disease
• Stage I or II disease with 1 lymph node or tumor > 5 cm in diameter
• First relapse or refractory disease

PATIENT CHARACTERISTICS:

Age

• Any age

Performance status

• ECOG 0-3

Life expectancy

• More than 3 months

Hematopoietic

• No history of hemolysis indicative of G6PD deficiency

Hepatic

• See Disease Characteristics

Renal

• Not specified

Pulmonary

• No established diagnosis of asthma

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 30 days after study participation
• No severe, life-threatening atopic allergy
• No hypersensitivity to uricases or their excipients
• No known G6PD deficiency

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 12 months since prior rituximab
• No concurrent rituximab

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No concurrent urine alkalinization
• No other concurrent allopurinol
• No other concurrent uricolytic agents
• No other concurrent investigational drug

Please refer to this study by ClinicalTrials.gov identifier  NCT00086918

Arkansas
      Arkansas Children''''s Hospital, Little Rock,  Arkansas,  72202-3591,  United States; Recruiting
California
      Alta Bates Comprehensive Cancer Center, Berkeley,  California,  94704,  United States; Recruiting
      Children''''s Hospital and Health Center - San Diego, San Diego,  California,  92123-4282,  United States; Recruiting
      Children''''s Hospital of Orange County, Orange,  California,  92868,  United States; Recruiting
      Jonsson Comprehensive Cancer Center at UCLA, Los Angeles,  California,  90095-1678,  United States; Recruiting
Colorado
      Rocky Mountain Cancer Centers - Denver Midtown, Denver,  Colorado,  80218,  United States; Recruiting
Florida
      Nemours Children''''s Clinic, Jacksonville,  Florida,  32207,  United States; Recruiting
      University of Florida Health Science Center - Jacksonville, Jacksonville,  Florida,  32209,  United States; Recruiting
Kansas
      Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City,  Kansas,  66160-7357,  United States; Recruiting
Louisiana
      Ochsner Cancer Institute at Ochsner Clinic Foundation, New Orleans,  Louisiana,  70121,  United States; Recruiting
Missouri
      St. Louis Children''''s Hospital, Saint Louis,  Missouri,  63110,  United States; Recruiting
New York
      James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester,  New York,  14642,  United States; Recruiting
      New York Medical College, Valhalla,  New York,  10595,  United States; Recruiting
      New York Methodist Hospital, Brooklyn,  New York,  11215,  United States; Recruiting
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States; Recruiting
Oklahoma
      Children''''s Hospital at Oklahoma University Medical Center, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Pennsylvania
      Abramson Cancer Center of the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104-4283,  United States; Recruiting
Tennessee
      St. Jude Children''''s Research Hospital, Memphis,  Tennessee,  38105,  United States; Recruiting
Texas
      M.D. Anderson Cancer Center at University of Texas, Houston,  Texas,  77030-4009,  United States; Recruiting
West Virginia
      Mary Babb Randolph Cancer Center at West Virginia University Hospitals, Morgantown,  West Virginia,  26506-9162,  United States; Recruiting

Study chairs or principal investigators

Richard A. Gams, MD,  Study Chair,  Prologue Research International   

Study ID Numbers:  CDR0000371829; PROLOGUE-EFC5339; SANOFI-EFC5339; UCLA-0403072-01
Last Updated:  August 1, 2005
Record first received:  July 8, 2004
ClinicalTrials.gov Identifier:  NCT00086918
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23