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