Study of Rasburicase as Treatment or Prevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Patients With Relapsed or Refractory Lymphoma, Leukemia, or Solid Tumor Malignancy - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00230217

Purpose

This is an open-label, multi-center study with 2 arms. The primary objective is to assess the response to treatment with rasburicase in 2 populations of adult and pediatric patients with lymphoma/leukemia/solid tumor malignancies, those previously treated with a uricolytic agent, and those not previously treated with a uricolytic agent at their first relapse or refractory disease.

Condition	Intervention	Phase
Tumors Hyperuricemia Tumor Lysis Syndrome	Drug: Rasburicase (SR29142)	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment
Official Title:	Evaluation of Single Agent Rasburicase in Treatment/Prevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Adult and Pediatric Patients With Lymphoma/Leukemia/Solid Tumor Malignancies at Their First Relapse or Refractory Disease

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma

Drug Information available for: Rasburicase

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Positive response based on plasma uric acid levels. [ Time Frame: up to 48 hours after last administration. ]

Secondary Outcome Measures:

safety assessment

Enrollment:	94
Study Start Date:	March 2004
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Detailed Description:

This is a multi-center, 2 arm, open-label study;

Arm A: Patients previously treated with a uricolytic agent;
Arm B: Patients not previously treated with a uricolytic agent.

Patients receive rasburicase for 5 days and begin chemotherapy 4-24 hours after the first dose of rasburicase. Patients are followed at 14 and 35 days, at 3 and 6 months and every 6 months thereafter.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meets one of the following risk criteria for tumor lysis syndrome (TLS):

A patient is at high risk for TLS if he/she presents with:
- Hyperuricemia of malignancy (plasma uric acid > 7.5 mg/dL);
- A diagnosis of a very aggressive lymphoma/leukemia based on the Revised European-American Lymphoma (REAL) classification of lymphoma/leukemia;
- Acute myeloid leukemia (AML);
- Chronic myeloid leukemia (CML) in blast crisis; or
- High grade myelodysplastic syndrome (refractory anemia with excess blast, refractory anemia with excess blast in transformation, or chronic myelomonocytic leukemia) only if they have > 10% bone marrow blast and are given aggressive treatment similar to AML
A patient is at potential risk for TLS if he/she presents with:
- A diagnosis of an aggressive lymphoma/leukemia based on the REAL classification of lymphoma/leukemia plus 1 or more of the following criteria:
  - Lactate dehydrogenase (LDH) > 2 x upper limit of normal (ULN)(IU/L)
  - Stage III-IV disease
  - Stage I-II disease with 1 lymph node/tumor > 5 cm in diameter
Patients previously treated with a uricolytic agent or not at their first relapse or refractory disease
Eastern Cooperative Oncology Group (ECOG) performance status 0-3. ECOG equivalent derived from Karnofsky performance scale 100-30 or Lansky performance score 100-30 (patients < or = 16 years of age) may also be used.
Life expectancy >3 months
Negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (both males and females). A pregnancy test may be performed on serum or urine human chorionic gonadotropin (HCG).
Signed written informed consent

Exclusion Criteria:

History of established diagnosis of asthma or severe life-threatening atopic allergy
Hypersensitivity to uricases or any of the excipients
Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or history of hemolysis indicative of G6PD deficiency
Pregnant or lactating
Concomitant treatment with any investigational drug
Planned treatment with rituximab
Receipt of rituximab within the 12 month period prior to study entry
Unwilling or unable to comply with the requirements of the protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230217

Locations

United States, California
Alta Bates Comprehensive Cancer Center
Berkley, California, United States, 94704
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, Florida
University of Florida Health Science Center at Jacksonville
Jacksonville, Florida, United States, 32209
United States, New York
New York Medical College
Valhalla, New York, United States, 10595
United States, Oklahoma
University of Oklahoma HSC
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania, United States, 19104
United States, West Virginia
Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States, 26506-9162

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC5339
Study First Received:	September 28, 2005
Last Updated:	March 27, 2009
ClinicalTrials.gov Identifier:	NCT00230217 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Relapse
Refracturing
Leukemia
Lymphoma
Solid Tumor

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Disease
Immune System Diseases
Hyperuricemia
Gout Suppressants
Rasburicase
Pharmacologic Actions
Leukemia

Lymphatic Diseases
Neoplasms
Pathologic Processes
Therapeutic Uses
Syndrome
Tumor Lysis Syndrome
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on November 05, 2009