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Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome

Primary Purpose

Tumor Lysis Syndrome, Cancer, Hyperuricemia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rasburicase (SR29142)
Allopurinol
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tumor Lysis Syndrome focused on measuring Hyperuricemia, Tumor lysis syndrome, Leukemia, Lymphoma, Myelodysplastic Syndromes, Solid tumor cancers, Solid Tumor cancers with hyperuricemia Hyperuricemia (cancer patients only), Tumor lysis syndrome (cancer patients only)

Eligibility Criteria

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

Inclusion Criteria: Meets high risk or at potential risk 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 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, chronic myelomonocytic leukemia, and refractory anemia with excess blast in transformation) only if they have > 10% bone marrow blast involvement and are given aggressive treatment similar to AML. A patient is at potential risk for TLS if he/she presents with: A diagnosis of 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 at least 1 lymph node/tumor > 5 cm in diameter In addition to the above-mentioned eligibility criteria, the patients should have the following criteria: Eastern Cooperative Oncology Group (ECOG) performance status 0-3 Age >= 18 years Life expectancy > 3 months Negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (for both males and females). A pregnancy test may be performed on serum or urine human chorionic gonadotropin (HCG). Signed written informed consent

Sites / Locations

  • Alta Bates Comprehensive Cancer Center
  • UCLA Medical Center
  • Rocky Mountain Cancer Center
  • University of Florida Health Science Center at Jacksonville
  • Ochsner Clinic Foundation
  • Massachusetts General Hospital
  • New York Methodist Hospital
  • Roswell Park Cancer Institute
  • University of Rochester Medical Center
  • New York Medical College
  • Duke University Medical Center
  • Oregon Health and Sciences University
  • University of Pennsylvania Health Systems
  • University of Texas MD Anderson Cancer Center
  • Mary Babb Randolph Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm C

Arm Description

Rasburicase alone given as a single agent for 5 days

Rasburicase alone given as a single agent from Day 1 through Day 3, followed by oral allopurinol given from Day 3 through Day 5 (Day 3 is an overlap)

Oral allopurinol alone given as a single agent for 5 days

Outcomes

Primary Outcome Measures

Plasma Uric Acid Responder
Number of patients responding to treatment defined as plasma uric acid levels at Day 3 through Day 7 <7.5 mg/dl.

Secondary Outcome Measures

Plasma Uric Acid
Area under the curve concentration versus time curve extrapolated to infinity (AUC) of plasma uric acid values
Time to Uric Acid Control
Time from the first dose of study drug to the time at which plasma uric acid concentrations were determined <=7.5 mg/dl, measured -4, 4, 24, 48, 72, 96, 120, and 144 hours after infusion.

Full Information

First Posted
September 28, 2005
Last Updated
January 8, 2010
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00230178
Brief Title
Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome
Official Title
Evaluation of Single Agent Rasburicase for 5 Days Versus Sequential Treatment With Rasburicase From Day 1 Through 3 Followed by Oral Allopurinol From Day 3 Through 5 (Overlap on Day 3) Versus Single Agent Oral Allopurinol for 5 Days in the Management of Plasma Uric Acid in Adult Patients With Leukemia, Lymphoma, and Solid Tumor Malignancies at Risk for Hyperuricemia and Tumor Lysis Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
This is a randomized, multi-center, open-label, parallel group study with three arms: Rasburicase alone Rasburicase followed by Allopurinol Allopurinol alone The primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms.
Detailed Description
After signing the informed consent and having met the inclusion criteria, patients will be randomized to 1 of the 3 arms and treated for a total duration of 5 days. Patients in all arms will receive chemotherapy beginning 4-24 hours after the first dose of rasburicase or allopurinol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor Lysis Syndrome, Cancer, Hyperuricemia
Keywords
Hyperuricemia, Tumor lysis syndrome, Leukemia, Lymphoma, Myelodysplastic Syndromes, Solid tumor cancers, Solid Tumor cancers with hyperuricemia Hyperuricemia (cancer patients only), Tumor lysis syndrome (cancer patients only)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Rasburicase alone given as a single agent for 5 days
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Rasburicase alone given as a single agent from Day 1 through Day 3, followed by oral allopurinol given from Day 3 through Day 5 (Day 3 is an overlap)
Arm Title
Arm C
Arm Type
Active Comparator
Arm Description
Oral allopurinol alone given as a single agent for 5 days
Intervention Type
Drug
Intervention Name(s)
Rasburicase (SR29142)
Intervention Description
30-min IV infusion
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Intervention Description
Oral administration
Primary Outcome Measure Information:
Title
Plasma Uric Acid Responder
Description
Number of patients responding to treatment defined as plasma uric acid levels at Day 3 through Day 7 <7.5 mg/dl.
Time Frame
Day 3 through Day 7
Secondary Outcome Measure Information:
Title
Plasma Uric Acid
Description
Area under the curve concentration versus time curve extrapolated to infinity (AUC) of plasma uric acid values
Time Frame
Day 1 to Day 7
Title
Time to Uric Acid Control
Description
Time from the first dose of study drug to the time at which plasma uric acid concentrations were determined <=7.5 mg/dl, measured -4, 4, 24, 48, 72, 96, 120, and 144 hours after infusion.
Time Frame
Day 1 to Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets high risk or at potential risk 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 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, chronic myelomonocytic leukemia, and refractory anemia with excess blast in transformation) only if they have > 10% bone marrow blast involvement and are given aggressive treatment similar to AML. A patient is at potential risk for TLS if he/she presents with: A diagnosis of 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 at least 1 lymph node/tumor > 5 cm in diameter In addition to the above-mentioned eligibility criteria, the patients should have the following criteria: Eastern Cooperative Oncology Group (ECOG) performance status 0-3 Age >= 18 years Life expectancy > 3 months Negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (for both males and females). A pregnancy test may be performed on serum or urine human chorionic gonadotropin (HCG). Signed written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
International Clinical Development
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Alta Bates Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
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
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
New York Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Oregon Health and Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
University of Pennsylvania Health Systems
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19194
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
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

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Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome

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