Conditions: Osteosarcoma
Keywords: osteosarcoma high dose methotrexate leucovorin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 7
Healthy volunteers: no

Brief summary:
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

Detailed description:

Arms:
arm 1: HDMTX-LV with glucarpidase arm 2: HDMTX-LV with placebo arm 3: compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment

Interventions: intervention 1: glucarpidase intervention 2: leucovorin
Intervention descriptions: intervention 1: IV dose based on weight, two doses given for 5 minutes, 24 hours apart intervention 2: IV or po given every 6 hours

Protocol document: