- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00634504
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
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Arizona
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Phoenix, Arizona, United States, 85016
- Phoenix Children's Hospital
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California
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Los Angeles, California, United States, 90027
- Children's Hospital of Los Angeles
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Los Angeles, California, United States, 90017
- Good Samaritan Hospital
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Los Angeles, California, United States, 92868
- Children's Hospital of Orange County
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Oakland, California, United States, 94609
- Oakland's Children's Hospital
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Palo Alto, California, United States, 94304-1812
- Stanford University Medical Center & Lucile Packard Children's Hospital
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San Francisco, California, United States, 94115
- California Pacific Medical Center
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Colorado
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Aurora, Colorado, United States, 80045
- Children's Hospital for Cancer & Blood Disorders
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Florida
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Tampa, Florida, United States, 33607
- St. Joseph's Hospital
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Illinois
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Evanston, Illinois, United States, 60201
- Northshore University Health System
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Indiana
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Indianapolis, Indiana, United States, 46202
- Riley Hospital for Children
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Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky
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-
Massachusetts
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Worcester, Massachusetts, United States, 04655
- University of Massachusetts - Umass Memorial Medical Center
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of MS Medical Center
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Missouri
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Columbia, Missouri, United States, 65212
- University of Missouri-Columbia
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Saint Louis, Missouri, United States, 63110
- Washington University Medical Center
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Nebraska
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Lincoln, Nebraska, United States, 68506
- St. Elizabeth Regional Medical Center
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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North Carolina
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Greenville, North Carolina, United States, 27834
- ECU Brody School of Medicine
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Ohio
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Canton, Ohio, United States, 44718
- Gabrail Cancer Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Tennessee
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Memphis, Tennessee, United States, 38105
- St. Jude Children's Research Hospital
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Texas
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Houston, Texas, United States, 77030
- Texas Children's Hospital
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Utah
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Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Center
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Washington
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Seattle, Washington, United States, 98105
- Children's Hospital and Regional Medical Center
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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
|
single intravenous dose
Other Names:
|
Active Comparator: B
High-dose methotrexate and leucovorin without Voraxaze (glucarpidase)
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standard of care, leucovorin every 6 hours
Other Names:
|
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
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Bone Tissue
- Neoplasms, Connective Tissue
- Sarcoma
- Osteosarcoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Dermatologic Agents
- Micronutrients
- Vitamins
- Reproductive Control Agents
- Antidotes
- Vitamin B Complex
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Leucovorin
- Levoleucovorin
- Methotrexate
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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