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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

Primary Purpose

Tumors, Hyperuricemia, Tumor Lysis Syndrome

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rasburicase (SR29142)
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tumors focused on measuring Relapse, Refracturing, Leukemia, Lymphoma, Solid Tumor

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meets one of the following risk criteria for tumor lysis syndrome (TLS): A patient is at high risk for TLS if he/she presents with: Hyperuricemia of malignancy (plasma uric acid > 7.5 mg/dL); A diagnosis of a very aggressive lymphoma/leukemia based on the Revised European-American Lymphoma (REAL) classification of lymphoma/leukemia; Acute myeloid leukemia (AML); Chronic myeloid leukemia (CML) in blast crisis; or High grade myelodysplastic syndrome (refractory anemia with excess blast, refractory anemia with excess blast in transformation, or chronic myelomonocytic leukemia) only if they have > 10% bone marrow blast and are given aggressive treatment similar to AML A patient is at potential risk for TLS if he/she presents with: A diagnosis of an aggressive lymphoma/leukemia based on the REAL classification of lymphoma/leukemia plus 1 or more of the following criteria: Lactate dehydrogenase (LDH) > 2 x upper limit of normal (ULN)(IU/L) Stage III-IV disease Stage I-II disease with 1 lymph node/tumor > 5 cm in diameter Patients previously treated with a uricolytic agent or not at their first relapse or refractory disease Eastern Cooperative Oncology Group (ECOG) performance status 0-3. ECOG equivalent derived from Karnofsky performance scale 100-30 or Lansky performance score 100-30 (patients < or = 16 years of age) may also be used. Life expectancy >3 months Negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (both males and females). A pregnancy test may be performed on serum or urine human chorionic gonadotropin (HCG). Signed written informed consent Exclusion Criteria: History of established diagnosis of asthma or severe life-threatening atopic allergy Hypersensitivity to uricases or any of the excipients Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or history of hemolysis indicative of G6PD deficiency Pregnant or lactating Concomitant treatment with any investigational drug Planned treatment with rituximab Receipt of rituximab within the 12 month period prior to study entry Unwilling or unable to comply with the requirements of the protocol

Sites / Locations

  • Alta Bates Comprehensive Cancer Center
  • Rocky Mountain Cancer Center
  • University of Florida Health Science Center at Jacksonville
  • New York Medical College
  • University of Oklahoma HSC
  • University of Pennsylvania Health Systems
  • Mary Babb Randolph Cancer Center

Outcomes

Primary Outcome Measures

Positive response based on plasma uric acid levels.

Secondary Outcome Measures

safety assessment

Full Information

First Posted
September 28, 2005
Last Updated
March 27, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00230217
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
This is an open-label, multi-center study with 2 arms. The primary objective is to assess the response to treatment with rasburicase in 2 populations of adult and pediatric patients with lymphoma/leukemia/solid tumor malignancies, those previously treated with a uricolytic agent, and those not previously treated with a uricolytic agent at their first relapse or refractory disease.
Detailed Description
This is a multi-center, 2 arm, open-label study; Arm A: Patients previously treated with a uricolytic agent; Arm B: Patients not previously treated with a uricolytic agent. Patients receive rasburicase for 5 days and begin chemotherapy 4-24 hours after the first dose of rasburicase. Patients are followed at 14 and 35 days, at 3 and 6 months and every 6 months thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumors, Hyperuricemia, Tumor Lysis Syndrome
Keywords
Relapse, Refracturing, Leukemia, Lymphoma, Solid Tumor

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rasburicase (SR29142)
Primary Outcome Measure Information:
Title
Positive response based on plasma uric acid levels.
Time Frame
up to 48 hours after last administration.
Secondary Outcome Measure Information:
Title
safety assessment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets one of the following risk criteria for tumor lysis syndrome (TLS): A patient is at high risk for TLS if he/she presents with: Hyperuricemia of malignancy (plasma uric acid > 7.5 mg/dL); A diagnosis of a very aggressive lymphoma/leukemia based on the Revised European-American Lymphoma (REAL) classification of lymphoma/leukemia; Acute myeloid leukemia (AML); Chronic myeloid leukemia (CML) in blast crisis; or High grade myelodysplastic syndrome (refractory anemia with excess blast, refractory anemia with excess blast in transformation, or chronic myelomonocytic leukemia) only if they have > 10% bone marrow blast and are given aggressive treatment similar to AML A patient is at potential risk for TLS if he/she presents with: A diagnosis of an aggressive lymphoma/leukemia based on the REAL classification of lymphoma/leukemia plus 1 or more of the following criteria: Lactate dehydrogenase (LDH) > 2 x upper limit of normal (ULN)(IU/L) Stage III-IV disease Stage I-II disease with 1 lymph node/tumor > 5 cm in diameter Patients previously treated with a uricolytic agent or not at their first relapse or refractory disease Eastern Cooperative Oncology Group (ECOG) performance status 0-3. ECOG equivalent derived from Karnofsky performance scale 100-30 or Lansky performance score 100-30 (patients < or = 16 years of age) may also be used. Life expectancy >3 months Negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (both males and females). A pregnancy test may be performed on serum or urine human chorionic gonadotropin (HCG). Signed written informed consent Exclusion Criteria: History of established diagnosis of asthma or severe life-threatening atopic allergy Hypersensitivity to uricases or any of the excipients Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or history of hemolysis indicative of G6PD deficiency Pregnant or lactating Concomitant treatment with any investigational drug Planned treatment with rituximab Receipt of rituximab within the 12 month period prior to study entry Unwilling or unable to comply with the requirements of the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Alta Bates Comprehensive Cancer Center
City
Berkley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
University of Florida Health Science Center at Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
University of Oklahoma HSC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Pennsylvania Health Systems
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Mary Babb Randolph Cancer Center
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506-9162
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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