High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma

Randomized, Blinded, Placebo-Controlled Trial of High Dose Methotrexate With Leucovorin Rescue (HDMTX-LV) With or Without Glucarpidase in Osteosarcoma

The purpose of this study is to demonstrate whether use of glucarpidase facilitates administration of the next cycle of chemotherapy as scheduled and improves safety and tolerability of HDMTX given with LV

Inclusion Criteria:

• osteosarcoma
• eligible to receive 2 sequential cycles of HDMTX-LV

Exclusion Criteria:

• prior administration of glucarpidase
• progression of disease while on previous MTX treatment