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Brief Title: Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze
Official Title: An Open-Label Study to Assess the Pharmacokinetics of Leucovorin in Patients Receiving High Dose Methotrexate, With or Without Voraxaze Treatment
Study ID: NCT00634504
Brief Summary: The purpose of this study is to investigate whether the administration of Voraxaze reduces exposure to leucovorin and its active metabolite to below the level achieved in patients who have not received Voraxaze.
Detailed Description:
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, Saint 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
Name: Andrew Saunders, MD
Affiliation:
Role: STUDY_CHAIR
Name: Suzanne Kincaid, CCRA
Affiliation: BTG International Inc.
Role: STUDY_DIRECTOR