drugset / Trial / NCT03643133
Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
Trial evaluating the impact on efficacy of mifamurtide as add-on treatment to post-operative chemotherapy compared to post-operative chemotherapy alone in first-line treatment of patients with high-risk osteosarcoma (defined as metastatic osteosarcoma at diagnosis or localised osteosarcoma with poor histological response).
Timeline
- Start
- 2018-10-23
- Primary completion
- 2026-09
- Completion
- 2033-10
Publications
- Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.
- Brard C, Piperno-Neumann S, Delaye J, Brugieres L, Hampson LV, Le Teuff G, Le Deley MC, Gaspar N. Sarcome-13/OS2016 trial protocol: a multicentre, randomised, open-label, phase II trial of mifamurtide combined with postoperative chemotherapy for patients with newly diagnosed high-risk osteosarcoma. BMJ Open. 2019 May 19;9(5):e025877. doi: 10.1136/bmjopen-2018-025877.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mifamurtide | Other / unclassified | 2 mg/m2 | — |
| Background | Cisplatin | Other / unclassified | 100 mg/m2 | — |
| Background | Doxorubicin | Other / unclassified | 60 mg/m2 | — |
| Background | Etoposide | Small molecule | 75 mg/m2 | — |
| Background | Ifosfamide | Small molecule | 3 g | — |
| Background | Methotrexate | Small molecule | — | — |