Rasburicase in Patients at Risk for Tumor Lysis Syndrome - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center Sanofi-Aventis
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00628628

Purpose

Primary Objective:

-To determine the efficacy of rasburicase administered as a single dose followed by as needed dosing (investigational arm) as compared to fixed dosing for 5 days (standard treatment arm) in the treatment of patients at high risk or potential risk for tumor lysis syndrome.

Secondary Objectives:

To evaluate the plasma uric acid area under the curve (AUC) from baseline through 7 days.
To evaluate the incidence of renal insufficiency and electrolyte abnormalities.
To determine the safety and immunogenicity of rasburicase.
To evaluate the cost-effectiveness of the experimental treatment (investigational arm).

Condition	Intervention	Phase
Tumor Lysis Syndrome	Drug: Rasburicase	Phase II

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

Drug Information available for: Lactic acid Ammonium lactate Rasburicase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 2 Study of Rasburicase Administered by Two Different Schedules (Fixed Dosing vs. As Needed Dosing) in Patients at High Risk or Potential Risk for Tumor Lysis Syndrome

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

Primary Outcome Measures:

To compare how well rasburicase given in 2 different ways can help control or prevent TLS in patients who are at risk for TLS. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	65
Study Start Date:	January 2008
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental As Needed Rasburicase	Drug: Rasburicase Arm 1 = .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed; Arm 2 = .15 mg/kg IV Over 30 Minutes Daily
2: Experimental Fixed Dose Rasburicase	Drug: Rasburicase Arm 1 = .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed; Arm 2 = .15 mg/kg IV Over 30 Minutes Daily

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Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with hematological malignancies (leukemia/lymphoma) at high risk or potential risk for tumor lysis syndrome. High risk: hyperuricemia of malignancy (Uric acid levels >7.5); diagnosis of very aggressive lymphoma/leukemia based on Revised European-American Lymphoma (REAL) classification; acute myeloid leukemia, chronic myelocytic leukemia (CML) in blast crisis; high grade myelodysplastic syndrome only if they have >10% bone marrow blast involvement and given aggressive treatment similar to acute myeloid leukemia (AML) (continued on #2)
(continued from #1) Potential risk: diagnosis of aggressive lymphoma/leukemia based on (REAL) classification. Plus one or more of the following criteria: lactate dehydrogenase (LDH) >/= 2 x upper limit of normal (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
Previous therapy with urate oxidase
Other conditions unsuitable for participation in the trial in the Investigator's opinion
Unwillingness to comply with the requirements of the protocol
Use of allopurinol within 72 hours of the study entry

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628628

Contacts

Contact: Saroj Vadhan-Raj, MD

713-792-7966

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Saroj Vadhan-Raj, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Sanofi-Aventis

Investigators

Principal Investigator:

Saroj Vadhan-Raj, MD

U.T.M.D. Anderson Cancer Center

More Information

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

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Saroj Vadhan-Raj, MD/Professor )
Study ID Numbers:	2006-0918
Study First Received:	February 25, 2008
Last Updated:	December 30, 2008
ClinicalTrials.gov Identifier:	NCT00628628
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Tumor Lysis Syndrome
TLS
hyperuricemia
Leukemia
Lymphoma
Acute myeloid leukemia
Chronic myelocytic leukemia

CML
lactate dehydrogenase
LDH
Myelodysplastic Syndrome
Rasburicase
Elitek™

Study placed in the following topic categories:

Myelodysplastic syndromes
Immunoproliferative Disorders
Chronic myelogenous leukemia
Myelodysplasia
Myelodysplastic Syndromes
Acute myelogenous leukemia
Hyperuricemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute

Rasburicase
Leukemia
Lymphatic Diseases
Preleukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Tumor Lysis Syndrome
Lymphoproliferative Disorders
Acute myelocytic leukemia
Lymphoma

Additional relevant MeSH terms:

Pathologic Processes
Disease
Immune System Diseases
Therapeutic Uses

Syndrome
Antirheumatic Agents
Gout Suppressants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009