Clinical trial NCT00230217: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tumors
Hyperuricemia
Tumor Lysis Syndrome
Keywords: Relapse
Refracturing
Leukemia
Lymphoma
Solid Tumor
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-09-30
Enrollment: 94
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 criteria: 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

Primary outcomes:
measure: Positive response based on plasma uric acid levels.
timeFrame: up to 48 hours after last administration.
Secondary outcomes:
measure: safety assessment
Other outcomes:
Locations:
city: Berkley
country: United States
facility: Alta Bates Comprehensive Cancer 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: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Oklahoma City
country: United States
facility: University of Oklahoma HSC
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania Health Systems
state: Pennsylvania
city: Morgantown
country: United States
facility: Mary Babb Randolph Cancer Center
state: West Virginia
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References: