Clinical Trial: High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary:
Sponsor: BTG International Inc.

Current Primary Outcome: Patients Progressing to Next Chemotherapy Cycle [ Time Frame: 1 week after intervention ]

Original Primary Outcome: successful advancement to the next cycle of chemotherapy at scheduled time [ Time Frame: one week ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: BTG International Inc.

Dates:
Date Received: March 6, 2008
Date Started: October 2008
Date Completion:
Last Updated: September 9, 2014
Last Verified: September 2014