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

Not Recruiting

Trial ID: NCT00634504

Gender - ALL Accepting Healthy Volunteers - No

Purpose

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.

Official Title

An Open-Label Study to Assess the Pharmacokinetics of Leucovorin in Patients Receiving High Dose Methotrexate, With or Without Voraxaze Treatment

Stanford Investigator(s)

Neyssa Marina

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

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Intervention(s):

drug: glucarpidase, high-dose methotrexate, leucovorin

drug: high-dose methotrexate, leucovorin

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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