NCT00631631

Mifamurtide (L-MTP-PE) for High-Risk Osteosarcoma

Liposomal Muramyl Tripeptide Phosphatidyl Ethanolamine (L-MTP-PE) for High-risk Osteosarcoma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 205 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 2 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to collect information regarding the safety and tolerability of mifamurtide (liposomal muramyl tripeptide phosphatidyl ethanolamine; L-MTP-PE).

Detailed description

The drug being tested in this study is called mifamurtide (L-MTP-PE; liposomal muramyl tripeptide phosphatidyl ethanolamine). Mifamurtide is being used to treat people with osteosarcoma, a form of cancer. This was a patient-access study that looked at adverse events, disease progression, and overall survival in study participants. The study enrolled 205 patients, of whom 204 were treated with mifamurtide intravenously at a dose of 2 mg/m2 twice weekly (at least 3 days apart) for 12 weeks, and then weekly for an additional 24 weeks, for a total of 48 doses in 36 weeks (following surgery for primary or metastatic disease). This study was conducted in the United States. Participants could receive treatment for up to 9 months. This study was previously mis-categorized as an interventional study.

Conditions

• Osteosarcoma

Interventions

Type	Name	Description
DRUG	Mifamurtide (L-MTP-PE)	Solution for intravenous infusion

Timeline

• Start date: 2008-01-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2008-03-10
• Last updated: 2014-05-14

Locations

2 sites across 1 country: United States