Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze
NCT ID: NCT00634504
Last Updated: 2022-06-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2008-05-31
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
High-dose methotrexate, leucovorin, and Voraxaze
glucarpidase, high-dose methotrexate, leucovorin
single intravenous dose
B
High-dose methotrexate and leucovorin without Voraxaze (glucarpidase)
high-dose methotrexate, leucovorin
standard of care, leucovorin every 6 hours
Interventions
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glucarpidase, high-dose methotrexate, leucovorin
single intravenous dose
high-dose methotrexate, leucovorin
standard of care, leucovorin every 6 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Require intravenous leucovorin
Exclusion Criteria
* Arm A only: hereditary fructose or galactose intolerance
* Arm B only: delayed elimination of MTX
ALL
No
Sponsors
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BTG International Inc.
OTHER
Responsible Party
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Principal Investigators
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Andrew Saunders, MD
Role: STUDY_CHAIR
Suzanne Kincaid, CCRA
Role: STUDY_DIRECTOR
BTG International Inc.
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Good Samaritan Hospital
Los Angeles, California, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
Children's Hospital of Orange County
Los Angeles, California, United States
Oakland's Children's Hospital
Oakland, California, United States
Stanford University Medical Center & Lucile Packard Children's Hospital
Palo Alto, California, United States
California Pacific Medical Center
San Francisco, California, United States
Children's Hospital for Cancer & Blood Disorders
Aurora, Colorado, United States
St. Joseph's Hospital
Tampa, Florida, United States
NorthShore University Health System
Evanston, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
University of Kentucky
Lexington, Kentucky, United States
University of Massachusetts - Umass Memorial Medical Center
Worcester, Massachusetts, United States
University of MS Medical Center
Jackson, Mississippi, United States
University of Missouri-Columbia
Columbia, Missouri, United States
Washington University Medical Center
St Louis, Missouri, United States
St. Elizabeth Regional Medical Center
Lincoln, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
ECU Brody School of Medicine
Greenville, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Texas Children's Hospital
Houston, Texas, United States
Huntsman Cancer Center
Salt Lake City, Utah, United States
Children's Hospital and Regional Medical Center
Seattle, Washington, United States
Countries
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Other Identifiers
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PR001-CLN-pro017
Identifier Type: -
Identifier Source: org_study_id
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