Clinical trial NCT00230178: Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tumor Lysis Syndrome
Cancer
Hyperuricemia
Keywords: Hyperuricemia
Tumor lysis syndrome
Leukemia
Lymphoma
Myelodysplastic Syndromes
Solid tumor cancers
Solid Tumor cancers with hyperuricemia Hyperuricemia (cancer patients only)
Tumor lysis syndrome (cancer patients only)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-09-30
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma Uric Acid Responder
timeFrame: Day 3 through Day 7
Secondary outcomes:
measure: Plasma Uric Acid
timeFrame: Day 1 to Day 7
measure: Time to Uric Acid Control
timeFrame: Day 1 to Day 7
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Alta Bates Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Jacksonville
country: United States
facility: University of Florida Health Science Center at Jacksonville
state: Florida
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Sciences University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania Health Systems
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Morgantown
country: United States
facility: Mary Babb Randolph Cancer Center
state: West Virginia
Study officials:
affiliation: Sanofi
name: International Clinical Development
role: STUDY_DIRECTOR
References: