Status:
COMPLETED
Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze
Lead Sponsor:
BTG International Inc.
Conditions:
Osteosarcoma
Leukemia
Eligibility:
All Genders
Phase:
PHASE1
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 receive...
Eligibility Criteria
Inclusion
- Receiving High-dose methotrexate (HDMTX) with or without risk of methotrexate (MTX) toxicity, impaired renal function, and delayed MTX elimination
- Require intravenous leucovorin
Exclusion
- Arm A only: allergic reactions to lactose
- Arm A only: hereditary fructose or galactose intolerance
- Arm B only: delayed elimination of MTX
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00634504
Start Date
May 1 2008
End Date
August 1 2009
Last Update
June 6 2022
Active Locations (25)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
Good Samaritan Hospital
Los Angeles, California, United States, 90017
3
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
4
Children's Hospital of Orange County
Los Angeles, California, United States, 92868