Conditions: Osteosarcoma Leukemia Lymphoma
Keywords: high dose methotrexate Voraxaze leucovorin delayed elimination methotrexate toxicity rescue renal insufficiency
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 20
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: High-dose methotrexate, leucovorin, and Voraxaze arm 2: High-dose methotrexate and leucovorin without Voraxaze (glucarpidase)

Interventions: intervention 1: glucarpidase, high-dose methotrexate, leucovorin intervention 2: high-dose methotrexate, leucovorin
Intervention descriptions: intervention 1: single intravenous dose intervention 2: standard of care, leucovorin every 6 hours

Protocol document: