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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


Phase 4
N/A
N/A
Not Enrolling
Both
Tumors, Hyperuricemia, Tumor Lysis Syndrome

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Positive response based on plasma uric acid levels.

Outcome Time Frame:

up to 48 hours after last administration.

Principal Investigator

ICD CSD

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC5339

NCT ID:

NCT00230217

Start Date:

March 2004

Completion Date:

July 2006

Related Keywords:

  • Tumors
  • Hyperuricemia
  • Tumor Lysis Syndrome
  • Relapse
  • Refracturing
  • Leukemia
  • Lymphoma
  • Solid Tumor
  • Leukemia
  • Lymphoma
  • Tumor Lysis Syndrome
  • Hyperuricemia

Name

Location

New York Medical CollegeValhalla, New York  10595
Rocky Mountain Cancer CenterDenver, Colorado  80218
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
University of Pennsylvania Health SystemsPhiladelphia, Pennsylvania  19104-9104
Mary Babb Randolph Cancer CenterMorgantown, West Virginia  26506
University of Florida Health Science Center at JacksonvilleJacksonville, Florida  32209
University of Oklahoma HSCOklahoma City, Oklahoma  73104