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

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00230217

Collaborator

(none)

Enrollment

Locations

Duration (Months)

13.4

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Tumors Hyperuricemia Tumor Lysis Syndrome	Drug: Rasburicase (SR29142)	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

94 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Study Start Date :

Mar 1, 2004

Actual Primary Completion Date :

Jul 1, 2006

Actual Study Completion Date :

Jul 1, 2006

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

safety assessment []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Alta Bates Comprehensive Cancer Center	Berkley	California	United States	94704
2	Rocky Mountain Cancer Center	Denver	Colorado	United States	80218
3	University of Florida Health Science Center at Jacksonville	Jacksonville	Florida	United States	32209
4	New York Medical College	Valhalla	New York	United States	10595
5	University of Oklahoma HSC	Oklahoma City	Oklahoma	United States	73104
6	University of Pennsylvania Health Systems	Philadelphia	Pennsylvania	United States	19104
7	Mary Babb Randolph Cancer Center	Morgantown	West Virginia	United States	26506-9162