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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
N/A
N/A
Not Enrolling
Both
Osteosarcoma, Leukemia, Lymphoma

Thank you

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:

Interventional

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:

No

Principal Investigator

Andrew Saunders, MD

Investigator Role:

Study Chair

Authority:

United States: Food and Drug Administration

Study ID:

PR001-CLN-pro017

NCT ID:

NCT00634504

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

Name

Location

Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Hackensack University Medical CenterHackensack, New Jersey  07601
Children's Hospital of Orange CountyOrange, California  92668
Washington University Medical CenterSaint Louis, Missouri  63105
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
St. Elizabeth Regional Medical CenterLincoln, Nebraska  68510
California Pacific Medical CenterSan Francisco, California  94115
University of KentuckyLexington, Kentucky  40536-0098
Texas Children's HospitalHouston, Texas  
Gabrail Cancer CenterCanton, Ohio  44718
St. Joseph's HospitalTampa, Florida  33607
Children's Hospital of Los AngelesLos Angeles, California  90027
University Of Missouri-ColumbiaColumbia, Missouri  65212
Riley Hospital for ChildrenIndianapolis, Indiana  46202
NorthShore University health systemEvanston, Illinois  60201
Good Samaritan HospitalLos Angeles, California  90017
Oakland's Children's HospitalOakland, California  94609
Stanford University Medical Center & Lucile Packard Children's HospitalPalo Alto, California  94304-1812
Children's Hospital for Cancer & Blood DisordersAurora, Colorado  80045
University of Massachusetts - Umass Memorial Medical CenterWorcester, Massachusetts  04655
University of MS Medical CenterJackson, Mississippi  39216
ECU Brody School of MedicineGreenville, North Carolina  27834
Huntsman Cancer CenterSalt Lake City, Utah  84112
Children's Hospital and Regional Medical CenterSeattle, Washington  98105