Surveillance Study of Patients With Newly Diagnosed Osteosarcoma

Study Overview
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Brief Summary
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This study is an observational safety surveillance study designed to prospectively assess patients with high-grade osteosarcoma who are candidates for treatment with mifamurtide within the context of prevailing standard oncology practice

Official Title
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Observational, Noninterventional Surveillance Study of Patients With Newly Diagnosed Osteosarcoma

Conditions
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Osteosarcoma

Intervention / Treatment
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* Drug: Mifamurtide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High-grade osteosarcoma patients<br> | Drug: Mifamurtide<br>* Mifamurtide will be prescribed to patients with high-grade osteosarcoma as part of their treatment regimen within the context of prevailing standard oncology practice. The recommended dose of mifamurtide is 2 mg/m2. Mifamurtide will be administered for 36 weeks as adjuvant therapy following surgical resection.<br>* Other names: MEPACT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term safety profile of mifamurtide during treatment (mifamurtide in combination with chemotherapy) | Adverse events of special interest (AESIs), including important identified and potential risks The frequency and pattern of mifamurtide-related infusion adverse events | 36 weeks | 
| The long-term safety profile of mifamurtide during and following treatment (mifamurtide in combination with chemotherapy) | Assessment of AESIs, consisting of important identified and potential risks | Up to 5 years from the last dose of mifamurtide or until death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | Up to 5 years from the last dose of mifamurtide or until death | 
| Overall Survival |  | Up to 5 years from the last dose of mifamurtide or until death |