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| 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. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
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. |
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| 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 |
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| 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 |
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| 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 |
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| Intervention † | Drug: rasburicase | ||||
| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 170 | ||||
| Start Date † | November 2003 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Pulmonary
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| 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 † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | May 2007 | ||||
| First Received Date † | July 8, 2004 | ||||
| Last Updated Date | May 23, 2008 | ||||