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

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.

Completed

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Key information

Conditions

Osteosarcoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Kidney Diseases Leukemia Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Renal Insufficiency Sarcoma Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Phoenix Children's Hospital, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glucarpidase, high-dose methotrexate, leucovorin

Drug

single intravenous dose

Other names: Voraxaze, carboxypeptidase G2, high dose methotrexate, leucovorin

high-dose methotrexate, leucovorin

Drug

standard of care, leucovorin every 6 hours

Other names: HDMTX, LV

Primary outcomes

Pharmacokinetics (PK) of Leucovorin

Time frame: 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.

Sponsors and collaborators

Lead sponsor

BTG International Inc.

Other

Registry information

Official study title

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

Acronym: LVPK

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Mar 13, 2008
Registry last updated: Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed