Overview

Pharmacokinetic Evaluation of Rasburicase in Patients With Leukemia and/or Lymphoma at High Risk of TLS

Status:
Completed
Trial end date:
2007-04-01
Target enrollment:
0
Participant gender:
All
Summary
Primary 1. To determine the pharmacokinetic (PK) parameters of rasburicase in adult patients with leukemia and/or lymphoma at high risk or potential risk of tumor lysis syndrome (TLS) Secondary 1. To evaluate plasma uric acid AUC from baseline (within 4 hours prior to first rasburicase treatment) through 48 hours after the last per-protocol planned administration of rasburicase treatment; 2. To evaluate the safety of rasburicase in adult patients with leukemia and/or lymphoma. 3. To evaluate incidence, duration, and type of immune responses (IgG, IgE, and neutralizing antibody) to rasburicase.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Sanofi
Treatments:
Rasburicase
Criteria
Inclusion Criteria:

1. Age >/= 18

2. Risk of TLS: A. High risk: hyperuricemia of malignancy; diagnosis of aggressive
lymphoma/leukemia based on Revised European-American Lymphoma (REAL) classification;
acute myeloid leukemia in blast crisis; high grade myelodysplastic syndrome only if
they have >10% bone marrow blast involvement and given aggressive treatment similar to
AML; OR B. Potential risk: diagnosis of aggressive lymphoma/leukemia based on (REAL)
classification. Plus one or more of the following criteria: LDH >/=2 x ULN; Stage
III-IV disease; Stage I-II disease with at least 1 lymph node/tumor >5cm in diameter.

3. ECOG performance status 0-3

4. Life expectancy >3 months

5. Negative pregnancy test (females of child bearing potential) within rasburicase dose and use of efficient contraceptive method (both males and females).
Pregnancy test may be performed on serum (HCG) or urine (HCG)

6. Signed written informed consent (approved by the Institutional Review Board/Ethics
Committee) obtained prior to study entry

Exclusion Criteria:

1. Patient receiving any investigational drug for hyperuricemia within 30 days of planned
first treatment with rasburicase

2. Pregnancy or lactation

3. Known history of significant allergy problem or documented history of asthma or
asthmatic bronchitis

4. Known history of glucose-6-phosphate dehydrogenase deficiency

5. Known history of hemolysis and methemoglobinemia

6. Positive tests for HBs antigen, HCV antibodies, or HIV-1, 2 antibodies

7. Hypersensitivity to uricases or any of the excipients

8. Previous therapy with urate oxidase

9. Other conditions unsuitable for participation in the trial in the Investigator's
opinion

10. Unwilling to comply with the requirements of the protocol