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Annals of Oncology
Methods: This phase 4 study will assess osteosarcoma patients who are candidates
for mifamurtide therapy at European centres. (EudraCT: 2009-017204-89;
NCT01194284). Eligible patients are aged 2–30 years, with a confirmed diagnosis of
high-grade osteosarcoma. Approximately 150 patients are planned to be entered, and
recruited over a 2-year period. Patients will receive the standard schedule of 2 mg/m 2
IV mifamurtide, administered twice weekly for 12 weeks then once weekly for 24
weeks (total 36 weeks). The primary objectives are to assess the short- (during
treatment) and long-term (≤5 years from last mifamurtide dose or until death) safety
profile of mifamurtide, including evaluation of AEs of special interest (defined as
important identified and potential risks) to take into account the risk of recurrence
and comorbidities with chemotherapy. Secondary objectives include assessment of
disease status, disease-free survival and overall survival.
Disclosure: C. Oliva: Employment: Takeda. Y. Liu: Employment: Millennium. All
other authors have declared no conflicts of interest.
Volume 23 | Supplement 9 | September 2012 doi:10.1093/annonc/mds414 | ix491