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Study on Mifamurtide with Chemotherapy for Patients with High-Risk Osteosarcoma

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of bone cancer called osteosarcoma, which is considered high-risk. High-risk osteosarcoma can either be metastatic, meaning it has spread to other parts of the body at the time of diagnosis, or it can be localized but shows a poor response to initial treatment. The study is evaluating the effectiveness of a medication called mifamurtide, also known by its code name MEPACT, when used in combination with standard chemotherapy treatments. The chemotherapy medications involved in this study include doxorubicin hydrochloride, ifosfamide, cisplatin, methotrexate, and etoposide.

The purpose of the study is to determine if adding mifamurtide to the usual chemotherapy regimen can improve the outcomes for patients with high-risk osteosarcoma. Participants in the study will receive either the standard chemotherapy alone or the standard chemotherapy combined with mifamurtide. The treatment will be administered over a period of several weeks, and the effects will be monitored to see if the combination helps in preventing the cancer from returning or spreading.

Throughout the study, participants will be closely observed to track their progress and any side effects they may experience. The study aims to provide valuable information on whether the addition of mifamurtide can enhance the effectiveness of chemotherapy in treating high-risk osteosarcoma, potentially leading to better survival rates and outcomes for patients. The trial will continue until the estimated end date in 2033, allowing researchers to gather comprehensive data on the long-term effects and benefits of the treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is confirmed to have high-risk osteosarcoma, which is a type of bone cancer. This includes either metastatic osteosarcoma at diagnosis or localized disease with a poor response to initial treatment.

    The patient must be between 2 and 50 years old and have undergone surgery to remove the primary tumor and any lung metastases, if applicable.

  2. Step 2

    Randomization

    The patient is randomly assigned to receive either standard post-operative chemotherapy alone or chemotherapy combined with mifamurtide.

    This process ensures that each patient has an equal chance of receiving either treatment option.

  3. Step 3

    Chemotherapy treatment

    The patient receives a combination of chemotherapy drugs, which include doxorubicin hydrochloride, ifosfamide, cisplatin, methotrexate, and etoposide. These drugs are administered through an intravenous route, meaning they are given directly into a vein.

    The specific dosage and frequency of these medications are determined by the healthcare team based on the patient's individual needs and response to treatment.

  4. Step 4

    Mifamurtide administration

    For patients receiving mifamurtide, this medication is also given intravenously. It is administered as an add-on treatment to the chemotherapy regimen.

    The treatment with mifamurtide lasts for 36 weeks, during which its impact on event-free survival is evaluated.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, the patient's health and response to treatment are closely monitored. This includes regular check-ups and tests to assess the effectiveness of the treatment and to identify any side effects.

    The primary goal is to evaluate event-free survival, which measures the time until the first occurrence of cancer progression, relapse, or other significant events.

  6. Step 6

    Completion of the trial

    At the end of the trial, the patient's overall survival and progression-free survival are assessed. This involves determining the time from the start of the trial to any progression of the disease or death from any cause.

    The feasibility and safety of the treatment are also evaluated, including any long-term effects and the mechanisms of action of mifamurtide.

Who can join the trial?

12 criteria

  • Patients must be between the ages of 2 and 50 years old.
  • Patients must have been newly diagnosed with a type of bone cancer called high-grade osteosarcoma, confirmed by a biopsy.
  • The cancer must be considered high risk, which means it has certain risk factors.
  • Patients must have received pre-operative chemotherapy, which is treatment given before surgery to shrink the tumor.
  • Patients must have normal blood, kidney, heart, and liver functions.
  • Patients must have a plan for neoadjuvant chemotherapy, which is another term for pre-operative chemotherapy.
  • Patients must have their primary tumor removed after receiving pre-operative chemotherapy.
  • Patients must be registered in the study at the time of diagnosis.
  • Patients must be able to undergo the treatment and follow-up as outlined in the study.
  • Women who can have children must have a negative pregnancy test before joining the study.
  • Patients must provide written consent to participate in the study, which means they agree to join after understanding the details.
  • Patients must be part of a social insurance program.

Who cannot join the trial?

7 criteria

  • Patients older than 50 years cannot participate.
  • Patients younger than 2 years cannot participate.
  • Patients who do not have high-risk osteosarcoma are excluded. High-risk osteosarcoma means the cancer has spread to other parts of the body at the time of diagnosis or the cancer did not respond well to initial treatment.
  • Patients who have not had surgery to remove the main tumor and any lung tumors, if present, are excluded.
  • Patients who have not received chemotherapy before surgery are excluded.
  • Patients who are not able to receive additional treatment after surgery are excluded.
  • Patients who are not able to follow the study procedures or attend follow-up visits are excluded.
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Investigated drugs

  • Mifamurtide

    is being studied as an additional treatment to standard post-operative chemotherapy for patients with high-risk osteosarcoma. It is used to help improve the body's immune response against cancer cells, potentially increasing the chances of survival without the cancer returning.

  • Post-operative chemotherapy

    refers to the standard cancer treatment given after surgery to remove the tumor. It involves using drugs to kill any remaining cancer cells and reduce the risk of the cancer coming back. In this trial, it is used as a comparison to see if adding mifamurtide provides better outcomes for patients.

What is already known about the treatment

Mifamurtide – Mifamurtide is administered as an intravenous infusion, typically given over a period of 36 weeks as part of a treatment regimen. It is currently being studied in clinical trials for its effectiveness in treating high-risk osteosarcoma, particularly in patients aged 2 to 50 years who have either metastatic osteosarcoma at diagnosis or localized disease with a poor response to pre-operative chemotherapy. The medication works by stimulating the immune system to attack cancer cells, enhancing the body's natural defense mechanisms. Mifamurtide is classified as an immunomodulator, and its use is being evaluated to improve event-free survival when combined with post-operative chemotherapy.

Investigated diseases

Osteosarcoma – Osteosarcoma is a type of bone cancer that typically starts in the long bones, such as those in the arms and legs. It is most common in teenagers and young adults, but it can occur at any age. The disease is characterized by the formation of malignant bone tissue, which can lead to pain and swelling in the affected area. Osteosarcoma can be classified as high-risk when it is metastatic at diagnosis or when there is a poor histological response to pre-operative chemotherapy. The cancer can spread to other parts of the body, most commonly the lungs. Treatment often involves a combination of surgery and chemotherapy to manage the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514780-26-00Protocol codeUC-0150/1704Estimated enrolment315 patientsSponsorUnicancer

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