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Could a drug boost chemo for tough bone cancer?

NCT ID NCT03643133

Disease control Sponsor: UNICANCER Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether adding mifamurtide to standard chemotherapy helps people with high-risk osteosarcoma, a type of bone cancer. The study includes 60 patients aged 2 to 50 with newly diagnosed, aggressive disease. Researchers will compare survival and relapse rates between those who get mifamurtide plus chemo and those who get chemo alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mifamurtide (MEPACT)
What this could lead to
If it works, this could point toward a more effective treatment for high-risk osteosarcoma, potentially improving survival rates.
What could go wrong
This is a small, early-phase trial with only 60 participants. The drug may not improve outcomes and could cause side effects like fever or fatigue.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

60 people

The number who actually took part.

Started

Oct 2018

Expected to finish

Oct 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Registration Criteria: 1. All newly diagnosed, biopsy-proven, high-grade osteosarcoma, whatever the initial extension of the disease 2. Age \>2 years and ≤50 years; 3. Normal haematological, renal, cardiac and hepatic functions 4. Planned neoadjuvant chemotherapy as follows: 1. Methotrexate-Etoposide-Ifosfamide (M-EI regimen) for patients ≤25 years 2. Doxorubicin-Cisplatin-Ifosfamide (API-AI regimen) for patients 26-50 years 5. Written informed consent from patients and/or their parents/guardians before enrolment and any study-related procedure 6. Affiliation to a social insurance regimen Inclusion Criteria: 1. Patient with a histologically proven, confirmed by experts pathologists panel (before surgery at the latest), high-grade osteosarcoma 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: 1. Low grade osteosarcoma, parosteal or periosteal osteosarcoma 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.

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Conditions

The condition(s) this trial relates to.

Neoplasms, Bone Tissue osteosarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteosarcoma

Contacts and locations

Locations

  • CHRU de Nancy - Onco-hématologie pédiatrique

    Vandœuvre-lès-Nancy, France

  • CHU Amiens-Picardie - Service d'oncologie hématologie pédiatrique

    Amiens, France

  • CHU Arnaud de Villeneuve - Onco-hématologie pédiatrique

    Montpellier, France

  • CHU Bretonneau - Service d'oncologie médicale

    Tours, France

  • CHU Toulouse - Hôpital des Enfants - Service d'Hémato-Immuno-Oncologie

    Toulouse, France

  • CHU d'Angers - Service d'oncologie pédiatrique

    Angers, France

  • CHU de Caen - Service d'oncologie hématologie pédiatrique

    Caen, France

  • CHU de Grenoble - Service d'oncologie hématologie pédiatrique

    La Tronche, France

  • CHU de Nantes - Service d'oncologie hématologie pédiatrique

    Nantes, France

  • CHU de Nice - Service d'oncologie hématologie pédiatrique

    Nice, France

  • Centre Eugène Marquis - Service d'oncologie médicale

    Rennes, France

  • Centre Léon Bérard - IHOPE

    Lyon, France

  • Centre Léon Bérard - Service d'oncologie médicale

    Lyon, France

  • Centre Oscar Lambret - Unité d'onco-pédiatrie

    Lille, France

  • Hôpital Armand Trousseau - Service d'hématologie et d'oncologie pédiatrique

    Paris, France

  • Hôpital Charles Nicolle - Hémato-Immuno-Oncologie Pédiatrique

    Rouen, France

  • Hôpital Clocheville - Hématologie et oncologie pédiatrique

    Tours, France

  • Hôpital Cochin

    Paris, France

  • Hôpital Hautepierre - Onco-hématologie pédiatrique

    Strasbourg, France

  • Hôpital de Hautepierre - Onco-hématologie adulte

    Strasbourg, France

  • Hôpital de la Timone - Service d'oncologie pédiatrique

    Marseille, France

  • Hôpital de la Timone - service d'oncologie médicale

    Marseille, France

  • Institut Bergonié - Service d'oncologie médicale

    Bordeaux, France

  • Institut Claudius Regaud - service d'oncologie médicale

    Toulouse, France

  • Institut Curie - Service d'oncologie médicale

    Paris, 75000, France

  • Institut Curie - Service d'oncologie pédiatrique

    Paris, France

  • Institut Gustave Roussy - Service d'oncologie médicale

    Villejuif, France

  • Institut Gustave Roussy - Service de cancérologie de l'enfant et de l'adolescent

    Villejuif, 94800, France

  • Institut de Cancérologie de Lorraine - Service d'oncologie médicale

    Vandœuvre-lès-Nancy, France

  • Institut de Cancérologie de l'Ouest (Site René Gauducheau) - Service d'oncologie médicale

    Saint-Herblain, France

  • Institut régional du Cancer de Montpellier - Service d'oncologie médicale

    Montpellier, France

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