MEMOS: A Eurosarc Study of Mifamurtide in advanced osteosarcoma
Research type
Research Study
Full title
A Mechanistic Study Of Mifamurtide (MTP-PE) In Patients With Metastatic And/Or Recurrent Osteosarcoma
IRAS ID
130668
Contact name
Heather House
Contact email
Sponsor organisation
University of Oxford
Eudract number
2012-000615-84
ISRCTN Number
ISRCTN82138287
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Adding mifamurtide (MePact®) to adjuvant chemotherapy offers patients with surgically curative osteosarcoma an 8% improvement in overall survival. This is a phase II study to identify biological predictors of response to mifamurtide alone and in combination with ifosfamide. About 40 patients with advanced osteosarcoma will be recruited from Europe (10 from UK) over 18 months. They will enter one of 3 treatment arms. Patients whose disease is suitable for surgery will be treated with mifamurtide alone (arm a). Patients who cannot have surgery will have ifosfamide chemotherapy as usual plus mifamurtide. They will be randomised into Arm B or Arm C in order to compare different drug combination schedules. Biopsies (or resected tumour samples) will be obtained before and after 6 weeks initial therapy. All patients will continue on mifamurtide treatment for a total of 36 weeks. Patients will have 6 CT scans and give regular research blood samples during the course of the study. Mifamurtide is not licensed for advanced osteosarcoma. It will be given as a weekly intravenous infusion twice weekly for 12 weeks then once weekly for 24 weeks in accordance with the SPC.
The study will provide biological and imaging response data that may help select patients likely to benefit from mifamurtide in future. It will provide valuable information on the cellular mechanism of action of mifamurtide. It will also evaluate the safety and tolerability of mifamurtide in patients with advanced osteosarcoma along with information on overall survival and objective response rates. The results should be known in about two or three years after the start of the study and will be published.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
14/SC/0255
Date of REC Opinion
17 Jun 2014
REC opinion
Further Information Favourable Opinion