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

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Sanofi-Aventis
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00360438

Purpose

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

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;
To evaluate the safety of rasburicase in adult patients with leukemia and/or lymphoma.
To evaluate incidence, duration, and type of immune responses (IgG, IgE, and neutralizing antibody) to rasburicase.

Condition	Intervention	Phase
Leukemia Lymphoma Tumor Lysis Syndrome	Drug: Rasburicase	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title:	Pharmacokinetic Evaluation of Rasburicase Dosed for 5 Consecutive Days as Uricolytic Therapy in Adult Patients With Leukemia and/or Lymphoma at High or Potential Risk of Tumor Lysis Syndrome (TLS)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma

Drug Information available for: Rasburicase

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Effectiveness of rasburicase in treatment of patients with leukemia and/or lymphoma who are at high or potential risk for TLS. [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]

Enrollment:	18
Study Start Date:	July 2006
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Rasburicase: Experimental	Drug: Rasburicase 0.15mg/kg intravenously over 30 minutes once per day for 5 consecutive days.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age >/= 18
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.
ECOG performance status 0-3
Life expectancy >3 months
Negative pregnancy test (females of child bearing potential) within </=2 weeks of rasburicase dose and use of efficient contraceptive method (both males and females). Pregnancy test may be performed on serum (HCG) or urine (HCG)
Signed written informed consent (approved by the Institutional Review Board/Ethics Committee) obtained prior to study entry

Exclusion Criteria:

Patient receiving any investigational drug for hyperuricemia within 30 days of planned first treatment with rasburicase
Pregnancy or lactation
Known history of significant allergy problem or documented history of asthma or asthmatic bronchitis
Known history of glucose-6-phosphate dehydrogenase deficiency
Known history of hemolysis and methemoglobinemia
Positive tests for HBs antigen, HCV antibodies, or HIV-1, 2 antibodies
Hypersensitivity to uricases or any of the excipients
Previous therapy with urate oxidase
Other conditions unsuitable for participation in the trial in the Investigator's opinion
Unwilling to comply with the requirements of the protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360438

Locations

United States, Texas
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Sanofi-Aventis

Investigators

Principal Investigator:

Saroj Vadhan-Raj, M.D.

M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UT MD Anderson Cancer Center ( Saroj Vadhan-Raj, MD / Professor )
Study ID Numbers:	2006-0298
Study First Received:	August 2, 2006
Last Updated:	August 4, 2009
ClinicalTrials.gov Identifier:	NCT00360438 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Leukemia
Lymphoma
Tumor Lysis Syndrome

TLS
Rasburicase
Elitek

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Disease
Immune System Diseases
Gout Suppressants
Rasburicase
Pharmacologic Actions
Leukemia
Lymphatic Diseases

Neoplasms
Pathologic Processes
Therapeutic Uses
Syndrome
Tumor Lysis Syndrome
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on November 09, 2009