Mifamurtide (L-MTP-PE) for High-Risk Osteosarcoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00631631|
Recruitment Status : Completed
First Posted : March 10, 2008
Last Update Posted : May 14, 2014
|Condition or disease||Intervention/treatment|
|Osteosarcoma||Drug: Mifamurtide (L-MTP-PE)|
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.
|Study Type :||Observational|
|Actual Enrollment :||205 participants|
|Official Title:||Liposomal Muramyl Tripeptide Phosphatidyl Ethanolamine (L-MTP-PE) for High-risk Osteosarcoma|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
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
- Number of participants with adverse events [ Time Frame: 12 months or disease progression, whichever occurs first ]
- 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 ]
- Overall survival [ Time Frame: From date of enrollment to date of death ]
- Progression-free survival [ Time Frame: From date of enrollment to date of first documented disease progression or death ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|