Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze
- Conditions
- LymphomaOsteosarcomaLeukemia
- Interventions
- Drug: glucarpidase, high-dose methotrexate, leucovorin
- Registration Number
- NCT00634504
- Lead Sponsor
- BTG International Inc.
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Receiving High-dose methotrexate (HDMTX) with or without risk of methotrexate (MTX) toxicity, impaired renal function, and delayed MTX elimination
- Require intravenous leucovorin
- Arm A only: allergic reactions to lactose
- Arm A only: hereditary fructose or galactose intolerance
- Arm B only: delayed elimination of MTX
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B high-dose methotrexate, leucovorin High-dose methotrexate and leucovorin without Voraxaze (glucarpidase) A glucarpidase, high-dose methotrexate, leucovorin High-dose methotrexate, leucovorin, and Voraxaze
- Primary Outcome Measures
Name Time Method Pharmacokinetics (PK) of Leucovorin 5 minutes, 30 minutes, 1 hour, 2 hours and 3 hours post-LV administration Geometric mean (6S)-leucovorin area under the plasma concentration vs. time curve from time 0 to the 3-hour time point.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
Oakland's Children's Hospital
🇺🇸Oakland, California, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
ECU Brody School of Medicine
🇺🇸Greenville, North Carolina, United States
Good Samaritan Hospital
🇺🇸Los Angeles, California, United States
University of Missouri-Columbia
🇺🇸Columbia, Missouri, United States
Children's Hospital of Los Angeles
🇺🇸Los Angeles, California, United States
Stanford University Medical Center & Lucile Packard Children's Hospital
🇺🇸Palo Alto, California, United States
NorthShore University Health System
🇺🇸Evanston, Illinois, United States
University of Massachusetts - Umass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of MS Medical Center
🇺🇸Jackson, Mississippi, United States
Washington University Medical Center
🇺🇸Saint Louis, Missouri, United States
St. Elizabeth Regional Medical Center
🇺🇸Lincoln, Nebraska, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Children's Hospital of Orange County
🇺🇸Los Angeles, California, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Children's Hospital for Cancer & Blood Disorders
🇺🇸Aurora, Colorado, United States
St. Joseph's Hospital
🇺🇸Tampa, Florida, United States
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Huntsman Cancer Center
🇺🇸Salt Lake City, Utah, United States
Children's Hospital and Regional Medical Center
🇺🇸Seattle, Washington, United States