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

May 13, 2022 updated by: BTG International Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children's Hospital
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital of Los Angeles
      • Los Angeles, California, United States, 90017
        • Good Samaritan Hospital
      • Los Angeles, California, United States, 92868
        • Children's Hospital of Orange County
      • Oakland, California, United States, 94609
        • Oakland's Children's Hospital
      • Palo Alto, California, United States, 94304-1812
        • Stanford University Medical Center & Lucile Packard Children's Hospital
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital for Cancer & Blood Disorders
    • Florida
      • Tampa, Florida, United States, 33607
        • St. Joseph's Hospital
    • Illinois
      • Evanston, Illinois, United States, 60201
        • NorthShore University Health System
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Hospital for Children
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
    • Massachusetts
      • Worcester, Massachusetts, United States, 04655
        • University of Massachusetts - Umass Memorial Medical Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of MS Medical Center
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri-Columbia
      • Saint Louis, Missouri, United States, 63110
        • Washington University Medical Center
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • St. Elizabeth Regional Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • ECU Brody School of Medicine
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Center
    • Washington
      • Seattle, Washington, United States, 98105
        • Children's Hospital and Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
High-dose methotrexate, leucovorin, and Voraxaze
Drug: glucarpidase, high-dose methotrexate, leucovorin
single intravenous dose
Other Names:
  • Voraxaze, carboxypeptidase G2, high dose methotrexate, leucovorin
Active Comparator: B
High-dose methotrexate and leucovorin without Voraxaze (glucarpidase)
Drug: high-dose methotrexate, leucovorin
standard of care, leucovorin every 6 hours
Other Names:
  • HDMTX, LV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 minutes, 30 minutes, 1 hour, 2 hours and 3 hours post-LV administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BTG International Inc.

Investigators

  • Study Chair: Andrew Saunders, MD
  • Study Director: Suzanne Kincaid, CCRA, BTG International Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

March 6, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Actual)

June 6, 2022

Last Update Submitted That Met QC Criteria

May 13, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR001-CLN-pro017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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