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

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