Observational, Noninterventional Surveillance Study of Patients With Newly Diagnosed Osteosarcoma
Inclusion Criteria
Inclusion Criteria
Each patient must meet all of the following inclusion criteria to be enrolled in the
study:
- Male or female aged 2 to 40 years
- Confirmed pathological diagnosis of newly-diagnosed, nonmetastatic, resectable,
primary, high-grade osteosarcoma
- Have completed definitive surgery (or other local ablation technique)
- Have a treatment regimen that includes mifamurtide and a minimum of 2 recognized
chemotherapy agents in the treatment of osteosarcoma (cisplatin, doxorubicin,
high-dose methotrexate or ifosfamide)
- Organ function deemed satisfactory to receive planned chemotherapy containing at
minimum 2 of the recognized chemotherapy agents in the treatment of osteosarcoma
- Voluntary Written Consent
Exclusion Criteria
Patients meeting any of the following exclusion criteria are not to be enrolled in the
study:
- Female patients who are lactating and breastfeeding or have a positive serum
pregnancy test during the screening period
- History of pericarditis or pleuritis
- Have low-grade osteosarcoma or parosteal or periosteal sarcoma
- Have osteosarcoma associated with Paget's disease
- Current treatment with any anticancer investigational products at the time of
enrollment in this study