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

Lymphoma Clinical Trial

— LVPK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00634504
• Other study ID #: PR001-CLN-pro017
• Status: Completed
• Phase: Phase 1
• Start date: May 2008
• Est. completion date: August 2009

Study information

• Verified date: May 2022
• Source: BTG International Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

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

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Osteosarcoma

Intervention

Drug:
• glucarpidase, high-dose methotrexate, leucovorin
single intravenous dose
• high-dose methotrexate, leucovorin
standard of care, leucovorin every 6 hours

Locations

Country	Name	City	State
United States	Children's Hospital for Cancer & Blood Disorders	Aurora	Colorado
United States	Gabrail Cancer Center	Canton	Ohio
United States	University of Missouri-Columbia	Columbia	Missouri
United States	NorthShore University Health System	Evanston	Illinois
United States	ECU Brody School of Medicine	Greenville	North Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Texas Children's Hospital	Houston	Texas
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	University of MS Medical Center	Jackson	Mississippi
United States	University of Kentucky	Lexington	Kentucky
United States	St. Elizabeth Regional Medical Center	Lincoln	Nebraska
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	Children's Hospital of Orange County	Los Angeles	California
United States	Good Samaritan Hospital	Los Angeles	California
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	Oakland's Children's Hospital	Oakland	California
United States	Stanford University Medical Center & Lucile Packard Children's Hospital	Palo Alto	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Washington University Medical Center	Saint Louis	Missouri
United States	Huntsman Cancer Center	Salt Lake City	Utah
United States	California Pacific Medical Center	San Francisco	California
United States	Children's Hospital and Regional Medical Center	Seattle	Washington
United States	St. Joseph's Hospital	Tampa	Florida
United States	University of Massachusetts - Umass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
BTG International Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 minutes, 30 minutes, 1 hour, 2 hours and 3 hours post-LV administration