Erwinia Asparaginase After Allergy to PEG-Asparaginase in Treating Young Patients With Acute Lymphoblastic Leukemia
NCT ID: NCT00537030
Last Updated: 2019-07-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
59 participants
INTERVENTIONAL
2008-02-11
Brief Summary
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Detailed Description
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I. To determine if the 48-hour trough serum asparaginase activity is ? 0.1 IU/mL in young patients with acute lymphoblastic leukemia treated with Erwinia asparaginase after allergy to PEG-asparaginase.
II. To determine the frequency of asparaginase-related toxicity in these patients.
III. To characterize the pharmacokinetics of Erwinia asparaginase in these patients.
SECONDARY OBJECTIVES:
I. To compare serum asparaginase activity and serum asparagine concentration between patients treated with Erwinia asparaginase on this trial and historical controls treated with PEG-asparaginase on CCG-1961 and CCG-1962.
II. To determine the 72-hour serum asparaginase activity on days 8 or 11 or 13 based on the starting date of Erwinia asparaginase therapy.
III. To determine the presence of anti-Erwinia asparaginase antibodies in patients treated with a course(s) of Erwinia asparaginase following clinical allergy to PEG-asparaginase (PEG, pegaspargase).
IV. To determine if serum asparagine is adequately depleted on days 12 or 13 in a subset of these patients.
OUTLINE: This is a multicenter study.
Patients receive 6 doses of Erwinia asparaginase intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.
Blood samples are collected periodically for pharmacokinetic, pharmacodynamic, and antibody studies.
After completion of study treatment, patients are followed periodically.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (chemotherapy)
Patients receive 6 doses of Erwinia asparaginase IM on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.
Asparaginase
Given IM
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Interventions
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Asparaginase
Given IM
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Concurrently enrolled on a frontline Children's Oncology Group treatment trial (i.e., COG-AALL0232 or COG-AALL0531, COG-AALL0331, or COG-AALL0434) at a participating institution
* Must have 1 or more courses of asparaginase remaining to be administered on the treatment protocol
* Must have had a grade ? 2 hypersensitivity reaction to PEG-asparaginase
* No history of pancreatitis ? grade 2
* No prior Erwinia asparaginase
1 Year
30 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Wanda Salzer
Role: PRINCIPAL_INVESTIGATOR
Children's Oncology Group
Locations
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Phoenix Childrens Hospital
Phoenix, Arizona, United States
Kaiser Permanente Downey Medical Center
Downey, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital Central California
Madera, California, United States
Children's Hospital of Orange County
Orange, California, United States
Rady Children's Hospital - San Diego
San Diego, California, United States
UCSF Medical Center-Mount Zion
San Francisco, California, United States
UCSF Medical Center-Parnassus
San Francisco, California, United States
Harbor-University of California at Los Angeles Medical Center
Torrance, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Norton Children's Hospital
Louisville, Kentucky, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States
Kalamazoo Center for Medical Studies
Kalamazoo, Michigan, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States
The Childrens Mercy Hospital
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Other Identifiers
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NCI-2009-00316
Identifier Type: REGISTRY
Identifier Source: secondary_id
07-162
Identifier Type: -
Identifier Source: secondary_id
COG-AALL07P2
Identifier Type: -
Identifier Source: secondary_id
CDR0000566349
Identifier Type: -
Identifier Source: secondary_id
AALL07P2
Identifier Type: OTHER
Identifier Source: secondary_id
AALL07P2
Identifier Type: OTHER
Identifier Source: secondary_id
AALL07P2
Identifier Type: -
Identifier Source: org_study_id
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