Osteosarcoma
Conditions
Brief summary
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
Interventions
DRUGMifamurtide
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.
Sponsors
Millennium Pharmaceuticals, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short-term safety profile of mifamurtide during treatment (mifamurtide in combination with chemotherapy) | 36 weeks | * Adverse events of special interest (AESIs), including important identified and potential risks * The frequency and pattern of mifamurtide-related infusion adverse events |
| The long-term safety profile of mifamurtide during and following treatment (mifamurtide in combination with chemotherapy) | Up to 5 years from the last dose of mifamurtide or until death | Assessment of AESIs, consisting of important identified and potential risks |
Secondary
| Measure | 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 |
Countries
Austria
Outcome results
None listed