Clinical Trial: Rasburicase in Treating or Preventing High Levels of Uric Acid in the Blood and Tumor Lysis Syndrome in Patients With Relapsed or Refractory Lymphoma, Leukemia, or Solid Tumors

This study is currently recruiting patients.
Verified by National Cancer Institute (NCI) July 2005

Sponsored by: Prologue Research International
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00086918

Purpose

RATIONALE: Rasburicase is effective in preventing or controlling high levels of uric acid in the blood and tumor lysis syndrome.

PURPOSE: This phase IV trial is studying how well rasburicase works in treating or preventing high levels of uric acid in the blood and tumor lysis syndrome in patients who are receiving chemotherapy for relapsed or refractory lymphoma, leukemia, or solid tumors.

Condition Intervention Phase
Cancer
hyperuricemia
Tumor Lysis Syndrome
 Drug: rasburicase
 Procedure: chemoprotection
 Procedure: complications of therapy assessment/management
 Procedure: renal complications management
 Procedure: supportive care/therapy
Phase IV

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapies;   Immune System and Disorders;   Lymphatic Diseases;   Metabolic Disorders

Study Type: Interventional
Study Design: Treatment

Official Title: Phase IV Study of Rasburicase as Treatment or Prevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Patients With Relapsed or Refractory Lymphoma, Leukemia, or Solid Tumor Malignancy

Further Study Details: 

OBJECTIVES:

Primary

Secondary

  • Determine the safety of this drug in these patients.
  • Determine the plasma uric acid AUC in patients treated with this drug.
  • Determine the incidence, duration, and type of immune responses (immunoglobulin [Ig] G, IgE, and neutralizing antibody) in patients treated with this drug.
  • Determine the efficacy and safety of this drug, in relation to antibody generation and titer, in these patients.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to prior treatment with a uricolytic agent (yes vs no).

Patients receive rasburicase IV over 30 minutes on days 1-5 (or days 1-7). Treatment continues in the absence of unacceptable toxicity.

Patients receive cytoreductive chemotherapy off-study beginning 4-24 hours after the first dose of rasburicase.

Patients are followed at 14 days after the first dose of study treatment. After completion of study treatment, patients are followed at 30 days, at 3 and 6 months, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 170 patients (85 per stratum) will be accrued for this study within 18 months.

Eligibility

Genders Eligible for Study:  Both
Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • ECOG 0-3

Life expectancy

  • More than 3 months

Hematopoietic

  • No history of hemolysis indicative of G6PD deficiency

Hepatic

  • See Disease Characteristics

Renal

  • Not specified

Pulmonary

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 30 days after study participation
  • No severe, life-threatening atopic allergy
  • No hypersensitivity to uricases or their excipients
  • No known G6PD deficiency

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 12 months since prior rituximab
  • No concurrent rituximab

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No concurrent urine alkalinization
  • No other concurrent allopurinol
  • No other concurrent uricolytic agents
  • No other concurrent investigational drug

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00086918


Arkansas
      Arkansas Children''''s Hospital, Little Rock,  Arkansas,  72202-3591,  United States; Recruiting
Kimo Stine, MD  501-364-1494    StineKimoc@uams.edu 

California
      Alta Bates Comprehensive Cancer Center, Berkeley,  California,  94704,  United States; Recruiting
David H. Irwin, MD  510-204-3428    d.irwin@salick.com 

      Children''''s Hospital and Health Center - San Diego, San Diego,  California,  92123-4282,  United States; Recruiting
Richard Kadota, MD  858-966-5811 

      Children''''s Hospital of Orange County, Orange,  California,  92868,  United States; Recruiting
Wei-Ping V. Shen, MD  714-516-4348    vshen@choc.org 

      Jonsson Comprehensive Cancer Center at UCLA, Los Angeles,  California,  90095-1678,  United States; Recruiting
Gary J. Schiller, MD  310-825-5513    garyjs@ucla.edu 

Colorado
      Rocky Mountain Cancer Centers - Denver Midtown, Denver,  Colorado,  80218,  United States; Recruiting
Jeffrey V. Matous, MD  303-388-4876    jeffrey.matous@usoncology.com 

Florida
      Nemours Children''''s Clinic, Jacksonville,  Florida,  32207,  United States; Recruiting
Eric Sandler, MD  904-390-3600    esandler@nemours.org 

      University of Florida Health Science Center - Jacksonville, Jacksonville,  Florida,  32209,  United States; Recruiting
Troy H. Guthrie, MD  904-244-3072    troy.guthrie@jax.ufl.edu 

Kansas
      Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City,  Kansas,  66160-7357,  United States; Recruiting
Delva Deauna-Limayo, MD  913-588-6077    ddeauna@kumc.edu 

Louisiana
      Ochsner Cancer Institute at Ochsner Clinic Foundation, New Orleans,  Louisiana,  70121,  United States; Recruiting
Archie W. Brown, MD  504-842-3910 

Missouri
      St. Louis Children''''s Hospital, Saint Louis,  Missouri,  63110,  United States; Recruiting
Shalini Shenoy, MD  314-454-6018    shenoy@kids.wustl.edu 

New York
      James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester,  New York,  14642,  United States; Recruiting
Camille Abboud, MD  585-275-4099 

      New York Medical College, Valhalla,  New York,  10595,  United States; Recruiting
Karen Seiter, MD  914-493-7514    karen_seiter@nymc.edu 

      New York Methodist Hospital, Brooklyn,  New York,  11215,  United States; Recruiting
Muthuswamy Krishnamurthy, MD  718-369-8160 

      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States; Recruiting
Maria R. Baer, MD  716-845-5975 

Oklahoma
      Children''''s Hospital at Oklahoma University Medical Center, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
William H. Meyer, MD  405-271-5311    william-meyer@ouhsc.edu 

Pennsylvania
      Abramson Cancer Center of the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104-4283,  United States; Recruiting
Selina M. Luger, MD  215-662-6348 

Tennessee
      St. Jude Children''''s Research Hospital, Memphis,  Tennessee,  38105,  United States; Recruiting
Sima Jeha, MD  901-495-3901    sima.jeha@stjude.org 

Texas
      M.D. Anderson Cancer Center at University of Texas, Houston,  Texas,  77030-4009,  United States; Recruiting
Jorge Cortes, MD  713-794-5783    jcortes@mdanderson.org 

West Virginia
      Mary Babb Randolph Cancer Center at West Virginia University Hospitals, Morgantown,  West Virginia,  26506-9162,  United States; Recruiting
Solveig G. Ericson, MD, PhD  304-293-6859 

Study chairs or principal investigators

Richard A. Gams, MD,  Study Chair,  Prologue Research International   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000371829; PROLOGUE-EFC5339; SANOFI-EFC5339; UCLA-0403072-01
Last Updated:  August 1, 2005
Record first received:  July 8, 2004
ClinicalTrials.gov Identifier:  NCT00086918
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23



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