Fasturtec TLS Treatment / Prophylysis - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00651911

Purpose

An open-label study to determine the efficacy and safety of Rasburicase used for the prevention and treatment of tumor lysis syndrome

Condition	Intervention	Phase
Tumor Lysis Syndrome	Drug: urate oxidase	Phase IV

MedlinePlus related topics: Cancer

Drug Information available for: Rasburicase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicenter Open Label Study of the Efficacy and Safety of Rasburicase in the Treatment of Prophylysis for Tumor Lysis Syndrome

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

To assess the uricolytic response to rasburicase treatment [ Time Frame: 5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate tumor lysis risk factors, treatments for tumor lysis syndrome and complications of treatment in patients treated prophylactically or therapeutically for tumor lysis syndrome [ Time Frame: 5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection) ] [ Designated as safety issue: Yes ]

Enrollment:	45
Study Start Date:	July 2003
Study Completion Date:	July 2004

Intervention Details:

First injection of Rasburicase will be done the day of initiation of chemotherapy, or the day before, according to hyperuricemia. Additional doses are permitted q12h during the first 72 hours of chemotherapy if hyperuricemia persists or subject is considered to be at significant risk of tumor lysis complications.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Chemotherapy planned for at least 3 cycles
Undergoing cytoreductive chemotherapy for ALL, multiple myeloma or Burkitt's lymphoma stage III or IV
With a minimum life expectancy of 3 months
Uric acid > 8 mg%
Negative pregnancy test < or =to 2 weeks and efficient contraceptive method.
Negative HIV serology < or =to 4 weeks
Patient or legal guardian has signed a written informed consent

Exclusion Criteria:

Hypersensitivity to uricases or any of the excipients
Known history of G6PD deficiency.
Previous treatment with Rasburicase or Uricozyme®
Pregnancy or lactation
Treatment with any investigational drug within 30 days before planned first Rasburicase administration

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651911

Locations

United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Sharon Chang

Sanofi-Aventis

More Information

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( Study Director )
Study ID Numbers:	L_8637
Study First Received:	March 28, 2008
Last Updated:	March 31, 2008
ClinicalTrials.gov Identifier:	NCT00651911
Health Authority:	Taiwan: Department of Health

Study placed in the following topic categories:

Lymphatic Diseases
Uric Acid
Immunoproliferative Disorders

Tumor Lysis Syndrome
Lymphoproliferative Disorders
Rasburicase

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