Spots Global Cancer Trial Database for Mifamurtide (L-MTP-PE) for High-Risk Osteosarcoma

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Trial Identification

Brief Title: Mifamurtide (L-MTP-PE) for High-Risk Osteosarcoma

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

Study ID: NCT00631631

Conditions

Osteosarcoma

Interventions

Mifamurtide (L-MTP-PE)

Study Description

Brief 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.