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

Phase 1
Not Enrolling
Osteosarcoma, Leukemia, Lymphoma

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Trial Information

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetics (PK) of leucovorin

Outcome Time Frame:

Up to 3 hours after leucovorin

Safety Issue:


Principal Investigator

Andrew Saunders, MD

Investigator Role:

Study Chair


United States: Food and Drug Administration

Study ID:




Start Date:

May 2008

Completion Date:

August 2009

Related Keywords:

  • Osteosarcoma
  • Leukemia
  • Lymphoma
  • high dose methotrexate
  • Voraxaze
  • leucovorin
  • delayed elimination
  • methotrexate toxicity
  • rescue
  • renal insufficiency
  • Leukemia
  • Lymphoma
  • Osteosarcoma



Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
Hackensack University Medical Center Hackensack, New Jersey  07601
Children's Hospital of Orange County Orange, California  92668
Washington University Medical Center Saint Louis, Missouri  63105
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Phoenix Children's Hospital Phoenix, Arizona  85016-7710
St. Elizabeth Regional Medical Center Lincoln, Nebraska  68510
California Pacific Medical Center San Francisco, California  94115
University of Kentucky Lexington, Kentucky  40536-0098
Texas Children's Hospital Houston, Texas  
Gabrail Cancer Center Canton, Ohio  44718
St. Joseph's Hospital Tampa, Florida  33607
Children's Hospital of Los Angeles Los Angeles, California  90027
University Of Missouri-Columbia Columbia, Missouri  65212
Riley Hospital for Children Indianapolis, Indiana  46202
NorthShore University health system Evanston, Illinois  60201
Good Samaritan Hospital Los Angeles, California  90017
Oakland's Children's Hospital Oakland, California  94609
Stanford University Medical Center & Lucile Packard Children's Hospital Palo Alto, California  94304-1812
Children's Hospital for Cancer & Blood Disorders Aurora, Colorado  80045
University of Massachusetts - Umass Memorial Medical Center Worcester, Massachusetts  04655
University of MS Medical Center Jackson, Mississippi  39216
ECU Brody School of Medicine Greenville, North Carolina  27834
Huntsman Cancer Center Salt Lake City, Utah  84112
Children's Hospital and Regional Medical Center Seattle, Washington  98105