Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome

Cancer Clinical Trial

Official title:

Evaluation of Single Agent Rasburicase for 5 Days Versus Sequential Treatment With Rasburicase From Day 1 Through 3 Followed by Oral Allopurinol From Day 3 Through 5 (Overlap on Day 3) Versus Single Agent Oral Allopurinol for 5 Days in the Management of Plasma Uric Acid in Adult Patients With Leukemia, Lymphoma, and Solid Tumor Malignancies at Risk for Hyperuricemia and Tumor Lysis Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230178
• Other study ID #: EFC4978
• Status: Completed
• Phase: Phase 3
• First received: September 28, 2005
• Last updated: January 8, 2010
• Start date: April 2004
• Est. completion date: December 2007

Study information

• Verified date: January 2010
• 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 a randomized, multi-center, open-label, parallel group study with three arms:

• Rasburicase alone

• Rasburicase followed by Allopurinol

• Allopurinol alone

The primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms.

Description:

After signing the informed consent and having met the inclusion criteria, patients will be randomized to 1 of the 3 arms and treated for a total duration of 5 days. Patients in all arms will receive chemotherapy beginning 4-24 hours after the first dose of rasburicase or allopurinol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Meets high risk or at potential risk 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 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, chronic myelomonocytic leukemia, and refractory anemia with excess blast in transformation) only if they have > 10% bone marrow blast involvement and are given aggressive treatment similar to AML.

A patient is at potential risk for TLS if he/she presents with:

• A diagnosis of 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 at least 1 lymph node/tumor > 5 cm in diameter

In addition to the above-mentioned eligibility criteria, the patients should have the following criteria:

2. Eastern Cooperative Oncology Group (ECOG) performance status 0-3

3. Age >= 18 years

4. Life expectancy > 3 months

5. Negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (for both males and females). A pregnancy test may be performed on serum or urine human chorionic gonadotropin (HCG).

6. Signed written informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer
• Hyperuricemia
• Syndrome
• Tumor Lysis Syndrome

Intervention

Drug:
• Rasburicase (SR29142)
30-min IV infusion
• Allopurinol
Oral administration

Locations

Country	Name	City	State
United States	Alta Bates Comprehensive Cancer Center	Berkeley	California
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	New York Methodist Hospital	Brooklyn	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Rocky Mountain Cancer Center	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	University of Florida Health Science Center at Jacksonville	Jacksonville	Florida
United States	UCLA Medical Center	Los Angeles	California
United States	Mary Babb Randolph Cancer Center	Morgantown	West Virginia
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	University of Pennsylvania Health Systems	Philadelphia	Pennsylvania
United States	Oregon Health and Sciences University	Portland	Oregon
United States	University of Rochester Medical Center	Rochester	New York
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	Plasma Uric Acid Responder		Day 3 through Day 7	No
Secondary	Plasma Uric Acid		Day 1 to Day 7	No
Secondary	Time to Uric Acid Control		Day 1 to Day 7	No