NCT03643133

Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients

Multicentre, Randomised, Phase 2 Trial of Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients (Metastatic Osteosarcoma at Diagnosis or Localised Disease With Poor Histological Response)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Multicentre, randomised, open-label, phase II trial, with 2 parallel groups. After pre-operative chemotherapy and surgery of the primary tumour and lung metastases (if applicable), patients presenting high-risk osteosarcoma (defined as metastatic osteosarcoma at diagnosis or localised osteosarcoma with poor histological response) will be randomised between 2 arms: * Control arm: post-operative chemotherapy alone (with regimens adapted to the age of patient) * Experimental arm : post-operative chemotherapy combined with mifamurtide This randomised trial is part of a study recruiting all patients ≤50 years old with a newly diagnosed high-grade osteosarcoma.

Conditions

• Osteosarcoma

Interventions

Type	Name	Description
DRUG	Mifamurtide	48 doses overall over 36 weeks
COMBINATION_PRODUCT	EI or M-API regimen depending on patient age	M-API regimen: One course of high-dose Methotrexate (optional) followed by 5 courses of API, every 21 days EI regimen : 5 course of EI, every 21 days

Timeline

• Start date: 2018-10-23
• Primary completion: 2026-01-01
• Completion: 2033-10-01
• First posted: 2018-08-22
• Last updated: 2025-12-26

Locations

31 sites across 1 country: France