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

Osteosarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00634322
• Other study ID #: PR001-CLN-pro012
• Secondary ID: MDACC #2006-0246
• Status: Terminated
• Phase: Phase 2
• First received: March 6, 2008
• Last updated: September 9, 2014
• Start date: October 2008
• Est. completion date: April 2009

Study information

• Verified date: September 2014
• Source: BTG International Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteosarcoma

Intervention

Drug:
• glucarpidase
IV dose based on weight, two doses given for 5 minutes, 24 hours apart
• leucovorin
IV or po given every 6 hours

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
BTG International Inc.	M.D. Anderson Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients Progressing to Next Chemotherapy Cycle		1 week after intervention	No