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

Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230217
• Other study ID #: EFC5339
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2005
• Last updated: March 27, 2009
• Start date: March 2004
• Est. completion date: July 2006

Study information

• Verified date: March 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00086918
• NCT00247767

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. 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

2. Patients previously treated with a uricolytic agent or not at their first relapse or refractory disease

3. 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.

4. Life expectancy >3 months

5. 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).

6. Signed written informed consent

Exclusion Criteria:

1. History of established diagnosis of asthma or severe life-threatening atopic allergy

2. Hypersensitivity to uricases or any of the excipients

3. Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or history of hemolysis indicative of G6PD deficiency

4. Pregnant or lactating

5. Concomitant treatment with any investigational drug

6. Planned treatment with rituximab

7. Receipt of rituximab within the 12 month period prior to study entry

8. Unwilling or unable to comply with the requirements of the protocol

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hyperuricemia
• Neoplasms
• Syndrome
• Tumor Lysis Syndrome
• Tumors

Intervention

Drug:
• Rasburicase (SR29142)

Locations

Country	Name	City	State
United States	Alta Bates Comprehensive Cancer Center	Berkley	California
United States	Rocky Mountain Cancer Center	Denver	Colorado
United States	University of Florida Health Science Center at Jacksonville	Jacksonville	Florida
United States	Mary Babb Randolph Cancer Center	Morgantown	West Virginia
United States	University of Oklahoma HSC	Oklahoma City	Oklahoma
United States	University of Pennsylvania Health Systems	Philadelphia	Pennsylvania
United States	New York Medical College	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive response based on plasma uric acid levels.		up to 48 hours after last administration.
Secondary	safety assessment