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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 ongoing, but not recruiting participants.

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
Hyperuricemia
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Small Intestine Cancer
Tumor Lysis Syndrome
Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: rasburicase
Procedure: chemoprotection
Procedure: management of therapy complications
Procedure: renal complications management
Phase IV

Genetics Home Reference related topics:   Benign Tumors   Bone Marrow Diseases   Cancer  

MedlinePlus related topics:   Bone Marrow Diseases   Cancer   Immune System and Disorders   Leukemia, Adult Acute   Leukemia, Adult Chronic   Leukemia, Childhood   Lymphatic Diseases   Lymphoma   Multiple Myeloma  

ChemIDplus related topics:   Rasburicase  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Open Label
Official Title:   Evaluation of Single Agent Rasburicase in Treatment/Prevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Adult and Pediatric Patients With Lymphoma/Leukemia/Solid Tumor Malignancies at Their First Relapse or Refractory Disease

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Plasma uric acid concentration measured by the area under the curve (AUC) at baseline through 48 hours after the last dose of chemotherapy
  • Safety profile as measured by laboratory tests and adverse events at baseline through day 35

Secondary Outcome Measures:
  • Immune response to rasburicase as measured by plasma immunoassay (IgG, IgE, and neutralizing antibody) at baseline through 6 months after treatment or until negative after 6 months
  • Pharmacokinetics of rasburicase as measured by plasma levels at baseline through day 14

Estimated Enrollment:   170
Study Start Date:   November 2003

Detailed Description:

OBJECTIVES:

Primary

  • Determine response in patients with relapsed or refractory lymphoma, leukemia, or malignancy previously treated or not treated with rasburicase as treatment or prevention of hyperuricemia and tumor lysis syndrome.
  • Determine response to this drug in these patients.

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
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Meets 1 of the following risk criteria for tumor lysis syndrome:

    • At high-risk, with any of the following diagnoses:

      • Hyperuricemia of malignancy (plasma uric acid > 7.5 mg/dL)
      • Very aggressive lymphoma or leukemia in first relapse
      • Acute myeloid leukemia
      • Chronic myelogenous leukemia in blast crisis
      • One of the following high-grade myelodysplastic syndromes AND ≥ 10% bone marrow blasts AND are undergoing aggressive chemotherapy:

        • Refractory anemia with excess blasts [RAEB]
        • RAEB in transformation
        • Chronic myelomonocytic leukemia
    • At potential-risk AND a diagnosis of an aggressive lymphoma or leukemia AND meets at least 1 of the following criteria:

      • Lactic dehydrogenase ≥ 2 times upper limit of normal
      • Stage III or IV disease
      • Stage I or II disease with 1 lymph node or tumor > 5 cm in diameter
  • First relapse or refractory disease

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

  • No established diagnosis of asthma

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00086918

Locations
United States, California
Children's Hospital and Health Center - San Diego    
      San Diego, California, United States, 92123-4282
United States, Colorado
Rocky Mountain Cancer Centers - Denver Midtown    
      Denver, Colorado, United States, 80218
United States, Florida
University of Florida Health Science Center - Jacksonville    
      Jacksonville, Florida, United States, 32209
United States, Louisiana
Ochsner Cancer Institute at Ochsner Clinic Foundation    
      New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Massachusetts General Hospital Cancer Center    
      Boston, Massachusetts, United States, 02114-2617
United States, New York
New York Medical College    
      Valhalla, New York, United States, 10595
Roswell Park Cancer Institute    
      Buffalo, New York, United States, 14263-0001
United States, North Carolina
Duke Comprehensive Cancer Center    
      Durham, North Carolina, United States, 27705
United States, Oklahoma
Children's Hospital at Oklahoma University Medical Center    
      Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania    
      Philadelphia, Pennsylvania, United States, 19104-4283
United States, Tennessee
St. Jude Children's Research Hospital    
      Memphis, Tennessee, United States, 38105
United States, Texas
M.D. Anderson Cancer Center at University of Texas    
      Houston, Texas, United States, 77030-4009
United States, West Virginia
Mary Babb Randolph Cancer Center at West Virginia University Hospitals    
      Morgantown, West Virginia, United States, 26506-9162

Sponsors and Collaborators
Prologue Research International

Investigators
Study Chair:     Richard A. Gams, MD     Prologue Research International    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000371829, PROLOGUE-EFC5339, SANOFI-EFC5339, UCLA-0403072-01
First Received:   July 8, 2004
Last Updated:   January 12, 2008
ClinicalTrials.gov Identifier:   NCT00086918
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
tumor lysis syndrome  
hyperuricemia  
secondary myelodysplastic syndromes  
previously treated myelodysplastic syndromes  
AIDS-related peripheral/systemic lymphoma  
anaplastic large cell lymphoma  
angioimmunoblastic T-cell lymphoma  
recurrent adult Burkitt lymphoma  
recurrent adult diffuse large cell lymphoma  
recurrent adult diffuse mixed cell lymphoma  
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult T-cell leukemia/lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
small intestine lymphoma
stage III adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult immunoblastic large cell lymphoma

Study placed in the following topic categories:
Blast Crisis
Chronic myelogenous leukemia
Chronic myelomonocytic leukemia
Refractory anemia
Lymphoma, Mantle-Cell
Small non-cleaved cell lymphoma
Lymphoma, large-cell, immunoblastic
Central nervous system lymphoma, primary
Duodenal Neoplasms
Uric Acid
Preleukemia
Pathologic Processes
Leukemia, Prolymphocytic
Anemia, Refractory
Hemorrhagic Disorders
Multiple myeloma
Lymphoma, Large-Cell, Anaplastic
Neoplasm Metastasis
Acute myeloid leukemia, adult
Myelodysplastic syndromes

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Hemic and Lymphatic Diseases
Immune System Diseases
Blood Protein Disorders
Ileal Diseases
Gout Suppressants
Pharmacologic Actions
Pathological Conditions, Signs and Symptoms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Jejunal Diseases
Therapeutic Uses
Cardiovascular Diseases
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 15, 2008