Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients
NCT ID: NCT03643133
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2018-10-23
2033-10-31
Brief Summary
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Detailed Description
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* 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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control arm
Post-operative chemotherapy alone (EI or M-API regimen depending on patient age) :
M-API regimen (≤25 years) :
Doxorubicin 60 mg/m², Day 1 Ifosfamide 3 g/m² Day 1 and 2 Cisplatin 100 mg/m², Day 2
EI regimen (26-50 years) :
Etoposide 75 mg/m²/d, Day 1-4 Ifosfamide 3 g/m²/d, Day 1-4
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
Experimental arm
Post-operative chemotherapy (EI or M-API regimen) combined with Mifamurtide 2 mg/m² twice weekly post-randomisation for 12 weeks then weekly for 24 weeks
Mifamurtide
48 doses overall over 36 weeks
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
Interventions
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Mifamurtide
48 doses overall over 36 weeks
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Registered at diagnosis into the study
3. Primary tumour resected after pre-operative chemotherapy
4. Osteosarcoma classified as high risk because of at least one risk factor:
1. presence of distant metastases or skip metastases at diagnosis
2. and/or poor histological response to pre-operative chemotherapy (\>10% residual viable cells on the analysis of the primary tumour surgical specimen)
5. Pre-operative chemotherapy combining
1. Methotrexate-Etoposide-Ifosfamide (M-EI regimen) for patients ≤25 years
2. Doxorubicin-Cisplatin-Ifosfamide (API-AI regimen) for patients 26-50 years
6. Screening laboratory values must meet the following criteria (using CTCAE v4) and should be obtained within 7 days prior to randomisation:
1. Absolute neutrophil count ≥1.0 x 10⁹/L
2. Platelets ≥100 x 10⁹/L
3. Haemoglobin ≥8.0 g/mL
4. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN) in the absence of liver metastases or ≤5 x ULN in the presence of liver metastases
5. Total Bilirubin ≤2 x ULN (except Gilbert Syndrome: \<3.0 mg/dL) or Total Bilirubin ≤5.0 x ULN in the presence of liver metastases
6. Creatinine clearance ≥60 mL/min/1.73 m² according to the Schwartz or Cockcroft formula according to patient's age
7. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) done within 7 days prior to randomisation
8. Provision of dated and signed written informed consent for the randomised trial prior to any study specific procedures, sampling and analyses.
9. Patient fit to undergo protocol treatment and follow-up
10. Affiliation to a social insurance regimen
Exclusion Criteria
2. Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 3 years.
3. Osteosarcoma with multiple metastases for whom complete removal is not expected to be feasible even after shrinkage with chemotherapy
4. Progressive disease at any site under initial chemotherapy, confirmed before randomisation time, and not totally resected during surgery
5. Any medical condition precluding treatment with protocol chemotherapy
6. Fractional Shortening \<28% or left ventricular ejection fraction (LVEF) 50% before treatment (only for API post-operative chemotherapy) by echocardiogram or multigated acquisition (MUGA) scan
7. Pregnancy or breast-feeding
8. Hypersensitivity to the active substance or to any of the excipients
9. Concurrent use of immunodepressive treatment such as cyclosporine, tacrolimus or other calcineurin inhibitors
10. Concurrent use with high-dose non-steroidal anti-inflammatory drugs (NSAIDs, cyclooxygenase inhibitors)
11. Inflammatory or auto-immune disease, allergy or asthma requiring a chronic use of steroid treatment that cannot be stopped.
12. Patients with positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
13. Patients with positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection.
50 Years
ALL
No
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Nathalie MD GASPAR, PhD
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy Cancer Campus
Sophie MD PIPERNO-NEUMANN, PhD
Role: PRINCIPAL_INVESTIGATOR
Institut Curie
Locations
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CHU Amiens-Picardie - Service d'oncologie hématologie pédiatrique
Amiens, , France
CHU d'Angers - Service d'oncologie pédiatrique
Angers, , France
Institut Bergonié - Service d'oncologie médicale
Bordeaux, , France
CHU de Caen - Service d'oncologie hématologie pédiatrique
Caen, , France
CHU de Grenoble - Service d'oncologie hématologie pédiatrique
La Tronche, , France
Centre Oscar Lambret - Unité d'onco-pédiatrie
Lille, , France
Centre Léon Bérard - IHOPE
Lyon, , France
Centre Léon Bérard - Service d'oncologie médicale
Lyon, , France
Hôpital de la Timone - service d'oncologie médicale
Marseille, , France
Hôpital de la Timone - Service d'oncologie pédiatrique
Marseille, , France
CHU Arnaud de Villeneuve - Onco-hématologie pédiatrique
Montpellier, , France
Institut régional du Cancer de Montpellier - Service d'oncologie médicale
Montpellier, , France
CHU de Nantes - Service d'oncologie hématologie pédiatrique
Nantes, , France
CHU de Nice - Service d'oncologie hématologie pédiatrique
Nice, , France
Institut Curie - Service d'oncologie médicale
Paris, , France
Hôpital Armand Trousseau - Service d'hématologie et d'oncologie pédiatrique
Paris, , France
Hôpital Cochin
Paris, , France
Institut Curie - Service d'oncologie pédiatrique
Paris, , France
Centre Eugène Marquis - Service d'oncologie médicale
Rennes, , France
Hôpital Charles Nicolle - Hémato-Immuno-Oncologie Pédiatrique
Rouen, , France
Institut de Cancérologie de l'Ouest (Site René Gauducheau) - Service d'oncologie médicale
Saint-Herblain, , France
Hôpital de Hautepierre - Onco-hématologie adulte
Strasbourg, , France
Hôpital Hautepierre - Onco-hématologie pédiatrique
Strasbourg, , France
CHU Toulouse - Hôpital des Enfants - Service d'Hémato-Immuno-Oncologie
Toulouse, , France
Institut Claudius Regaud - service d'oncologie médicale
Toulouse, , France
CHU Bretonneau - Service d'oncologie médicale
Tours, , France
Hôpital Clocheville - Hématologie et oncologie pédiatrique
Tours, , France
CHRU de Nancy - Onco-hématologie pédiatrique
Vandœuvre-lès-Nancy, , France
Institut de Cancérologie de Lorraine - Service d'oncologie médicale
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy - Service de cancérologie de l'enfant et de l'adolescent
Villejuif, , France
Institut Gustave Roussy - Service d'oncologie médicale
Villejuif, , France
Countries
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References
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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.
Other Identifiers
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2017-001165-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
UC-0150/1704
Identifier Type: -
Identifier Source: org_study_id