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This is a mechanistic trial of Mifamurtide (MTP-PE) in patients with Metastatic and/or recurrent Osteosarcoma

brief summary

This is a Bayesian designed multi-arm, multi-centre, open label phase II study. The target sample size of 40 patients will be recruited from up to 8 EU countries, but this may be revised in light of the interim analysis. Patients with relapsed or metastatic osteosarcoma will be divided into three treatment groups. They will all either have surgery or a biopsy before and after six weeks exposure to either Mifamurtide alone, Ifosfamide alone, or Mifamurtide combined with Ifosfamide. They will then receive further treatment to a maximum of 42 or 36 weeks in total (depending on Arm), with all patients being able to receive 36 weeks of Mifamurtide treatment.

Primary Objective

To determine the efficacy of mifamurtide treatment.

 

TriaL Publications

 

The MEMOS trial was part of the EUROSARC programme. Details of the programme can be found at the following link: https://cordis.europa.eu/project/id/278742/reporting/de

Results for the trial can be found at the following links:-

1. https://clinicaltrials.gov/ct2/show/results/NCT02441309?term=NCT02441309&draw=2&rank=1

2. https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-000615-84/results