Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze

Completed · Phase 1

Conditions studied: Osteosarcoma, Leukemia, Lymphoma

In brief

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.

Key facts

Study ID

NCT00634504

Run by

BTG International Inc.

People needed

20

Starts

2008-05-01

Expected to finish

2009-08-01

Last updated by the study team

2022-06-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Receiving High-dose methotrexate (HDMTX) with or without risk of methotrexate (MTX) toxicity, impaired renal function, and delayed MTX elimination
• Require intravenous leucovorin

You may not qualify if…

• Arm A only: allergic reactions to lactose
• Arm A only: hereditary fructose or galactose intolerance
• Arm B only: delayed elimination of MTX

Where it is running

• 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

Full record on ClinicalTrials.gov

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