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

Phase 2

Terminated

• Conditions: Osteosarcoma
• Interventions: Drug: glucarpidase; Drug: leucovorin

• Registration Number: NCT00634322
• Lead Sponsor: BTG International Inc.

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

Not available

Study Timeline

• Study First Submitted: 2008-03-06
• Study First Submitted QC: 2008-03-06
• Study First Posted: 2008-03-13
• Study Start: 2008-10
• Primary Completion: 2009-03
• Study Completion: 2009-04
• Disposition First Submitted: 2011-07-28
• Disposition First Submitted QC: 2011-07-28
• Disposition First Posted: 2011-08-01
• Results First Submitted: 2012-11-30
• Status Verified: 2014-09
• Results First Submitted QC: 2014-09-09
• Last Update Submitted: 2014-09-09
• Results First Posted: 2014-09-15
• Last Update Posted: 2014-09-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	glucarpidase	HDMTX-LV with glucarpidase
B	leucovorin	HDMTX-LV with placebo
C	glucarpidase	compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment

Primary Outcome Measures

Name	Time	Method
Patients Progressing to Next Chemotherapy Cycle	1 week after intervention