Mifamurtide (L-MTP-PE) for High-Risk Osteosarcoma
The purpose of this study was to collect information regarding the safety and tolerability of mifamurtide (liposomal muramyl tripeptide phosphatidyl ethanolamine; L-MTP-PE).
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Liposomal Muramyl Tripeptide Phosphatidyl Ethanolamine (L-MTP-PE) for High-risk Osteosarcoma|
- Number of participants with adverse events [ Time Frame: 12 months or disease progression, whichever occurs first ] [ Designated as safety issue: Yes ]
- Serum concentration-time profiles of free and total mifamurtide in 15-20 patients [ Time Frame: Just before the start of the first infusion of mifamurtide and at 0.5, 1, 2, 4, 6 and, 24 hours following the start of the first infusion and just prior to the 2nd dose of mifamurtide ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: From date of enrollment to date of death ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: From date of enrollment to date of first documented disease progression or death ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Mifamurtide (L-MTP-PE), intravenous, at a dose of 2 mg/m^2 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.
Drug: Mifamurtide (L-MTP-PE)
Solution for intravenous infusion
Other Name: Liposomal Muramyl Tripeptide Phosphatidyl Ethanolamine
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631631
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Peter M. Anderson, MD, PhD||M.D. Anderson Cancer Center|