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 - Tabular View

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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.
Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

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

Brief Summary

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.

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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Supportive Care, Open Label

Primary Outcome Measure ^†

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 Measure ^†

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

Condition ^†

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

Intervention ^†

Drug: rasburicase

MEDLINE PMIDs

Links

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

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

170

Start Date ^†

November 2003

Completion Date

Eligibility 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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00086918

Organization ID

CDR0000371829

Secondary IDs ^††

PROLOGUE-EFC5339, SANOFI-EFC5339, UCLA-0403072-01

Study Sponsor ^†

Prologue Research International

Collaborators ^††

Investigators ^†

Study Chair:

Richard A. Gams, MD

Prologue Research International

Information Provided By

National Cancer Institute (NCI)

Verification Date

May 2007

First Received Date ^†

July 8, 2004

Last Updated Date

May 23, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.