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

Primary Purpose

Osteosarcoma, Leukemia, Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
glucarpidase, high-dose methotrexate, leucovorin
high-dose methotrexate, leucovorin
Sponsored by
BTG International Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteosarcoma focused on measuring high dose methotrexate, Voraxaze, leucovorin, delayed elimination, methotrexate toxicity, rescue, renal insufficiency

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phoenix Children's Hospital
  • Good Samaritan Hospital
  • Children's Hospital of Los Angeles
  • Children's Hospital of Orange County
  • Oakland's Children's Hospital
  • Stanford University Medical Center & Lucile Packard Children's Hospital
  • California Pacific Medical Center
  • Children's Hospital for Cancer & Blood Disorders
  • St. Joseph's Hospital
  • NorthShore University Health System
  • Riley Hospital for Children
  • University of Kentucky
  • University of Massachusetts - Umass Memorial Medical Center
  • University of MS Medical Center
  • University of Missouri-Columbia
  • Washington University Medical Center
  • St. Elizabeth Regional Medical Center
  • Hackensack University Medical Center
  • ECU Brody School of Medicine
  • Gabrail Cancer Center
  • Children's Hospital of Philadelphia
  • St. Jude Children's Research Hospital
  • Texas Children's Hospital
  • Huntsman Cancer Center
  • Children's Hospital and Regional Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

High-dose methotrexate, leucovorin, and Voraxaze

High-dose methotrexate and leucovorin without Voraxaze (glucarpidase)

Outcomes

Primary Outcome Measures

Pharmacokinetics (PK) of Leucovorin
Geometric mean (6S)-leucovorin area under the plasma concentration vs. time curve from time 0 to the 3-hour time point.

Secondary Outcome Measures

Full Information

First Posted
March 6, 2008
Last Updated
May 13, 2022
Sponsor
BTG International Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00634504
Brief Title
Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze
Acronym
LVPK
Official Title
An Open-Label Study to Assess the Pharmacokinetics of Leucovorin in Patients Receiving High Dose Methotrexate, With or Without Voraxaze Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BTG International Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 received Voraxaze.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteosarcoma, Leukemia, Lymphoma
Keywords
high dose methotrexate, Voraxaze, leucovorin, delayed elimination, methotrexate toxicity, rescue, renal insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
High-dose methotrexate, leucovorin, and Voraxaze
Arm Title
B
Arm Type
Active Comparator
Arm Description
High-dose methotrexate and leucovorin without Voraxaze (glucarpidase)
Intervention Type
Drug
Intervention Name(s)
glucarpidase, high-dose methotrexate, leucovorin
Other Intervention Name(s)
Voraxaze, carboxypeptidase G2, high dose methotrexate, leucovorin
Intervention Description
single intravenous dose
Intervention Type
Drug
Intervention Name(s)
high-dose methotrexate, leucovorin
Other Intervention Name(s)
HDMTX, LV
Intervention Description
standard of care, leucovorin every 6 hours
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK) of Leucovorin
Description
Geometric mean (6S)-leucovorin area under the plasma concentration vs. time curve from time 0 to the 3-hour time point.
Time Frame
5 minutes, 30 minutes, 1 hour, 2 hours and 3 hours post-LV administration

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Saunders, MD
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Suzanne Kincaid, CCRA
Organizational Affiliation
BTG International Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Good Samaritan Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Children's Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Children's Hospital of Orange County
City
Los Angeles
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Oakland's Children's Hospital
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Stanford University Medical Center & Lucile Packard Children's Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1812
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Children's Hospital for Cancer & Blood Disorders
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
St. Joseph's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
NorthShore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Massachusetts - Umass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
04655
Country
United States
Facility Name
University of MS Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
University of Missouri-Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Washington University Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Elizabeth Regional Medical Center
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
ECU Brody School of Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Huntsman Cancer Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Children's Hospital and Regional Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

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

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