NCT00230217

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2004

Typical duration for phase_4

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

March 30, 2009

Status Verified

March 1, 2009

Enrollment Period

2.3 years

First QC Date

September 28, 2005

Last Update Submit

March 27, 2009

Conditions

TumorsHyperuricemiaTumor Lysis Syndrome

Keywords

RelapseRefracturingLeukemiaLymphomaSolid Tumor

Outcome Measures

Primary Outcomes (1)

  • Positive response based on plasma uric acid levels.

    up to 48 hours after last administration.

Secondary Outcomes (1)

  • safety assessment

Interventions

Rasburicase (SR29142)DRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Alta Bates Comprehensive Cancer Center

Berkley, California, 94704, United States

Location

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

University of Florida Health Science Center at Jacksonville

Jacksonville, Florida, 32209, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

University of Oklahoma HSC

Oklahoma City, Oklahoma, 73104, United States

Location

University of Pennsylvania Health Systems

Philadelphia, Pennsylvania, 19104, United States

Location

Mary Babb Randolph Cancer Center

Morgantown, West Virginia, 26506-9162, United States

Location

MeSH Terms

Conditions

NeoplasmsHyperuricemiaTumor Lysis SyndromeRecurrenceLeukemiaLymphoma

Interventions

rasburicaseUrate Oxidase

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesNeoplasms by Histologic TypeHematologic Diseases

Intervention Hierarchy (Ancestors)

OxidoreductasesEnzymesEnzymes and Coenzymes

Study Officials

  • ICD CSD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 28, 2005

First Posted

September 30, 2005

Study Start

March 1, 2004

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

March 30, 2009

Record last verified: 2009-03

Locations

US(7)