INT-0133

NCT00003937 📎

Regimen

Experimental
MAP +/- ifosfamide and +/- MTP-PE (mifamurtide, muramyl tripeptide phosphatidylethanolamine)
Control
MAP alone in 2x2 factorial design

Population

Newly diagnosed resectable non-metastatic high-grade osteosarcoma, age <30

Key finding

MTP-PE added to MAP improved OS by ~8 percentage points; ifosfamide addition failed. Interpretation controversial due to factorial interaction. FDA rejected mifamurtide; EMA approved it. Ifosfamide failure here was the first warning for EURAMOS-1.

Source: PMID 18235123

Timeline

    Guideline citations

    • NCCN BONE (p.74)