RecruitingRare disease

Study on the Effectiveness and Safety of Naxitamab for Patients with Refractory Ewing's Sarcoma

Verified siteInvestigational

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 cancer called Ewing's sarcoma, which affects the bones or soft tissues. The study is testing a treatment called naxitamab, which is a humanized IgG1 monoclonal antibody designed to target a specific protein on cancer cells known as GD2. The treatment is given as a solution for infusion, meaning it is administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate the safety and effectiveness of adding naxitamab to the standard chemotherapy regimen for patients with refractory Ewing's sarcoma. "Refractory" means that the cancer has not responded to previous treatments. Participants in the study will receive either the combination of naxitamab and chemotherapy or chemotherapy alone. The study will monitor the safety of the treatment by observing any side effects and will also assess how well the cancer responds to the treatment.

Throughout the study, participants will undergo regular medical examinations and laboratory tests to track their health and the progress of the cancer. The study aims to provide valuable information on whether the addition of naxitamab can improve outcomes for patients with this challenging form of cancer. The trial is expected to continue until 2028, allowing researchers to gather comprehensive data on the treatment's long-term effects.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient must have a confirmed diagnosis of Ewing's sarcoma, either in the bone or soft tissues.
The patient must provide consent to use effective contraception during the study and for at least one year after stopping the treatment.
A sample of the patient's tumor must be available for evaluation of GD2 expression.
The patient must have shown disease progression or recurrence after previous treatment.
The patient must be between 2 and 21 years old and have a life expectancy of at least 12 weeks.
Previous cancer treatments must have been completed at least 3 weeks prior, major surgery at least 2 weeks prior, and radiation therapy at least 4 weeks prior to joining the study.
The patient must have recovered from any adverse effects of prior treatments.
Step 2
Treatment phase
The patient will receive a medication called naxitamab, which is a humanized IgG1 monoclonal antibody targeting GD2.
Naxitamab is administered as a solution for infusion, meaning it is given directly into the bloodstream through a vein.
The treatment involves adding naxitamab to a standard 3-week chemotherapy regimen.
The specific dosage and frequency of naxitamab administration will be determined by the study protocol.
Step 3
Monitoring and assessment
Throughout the study, the patient's safety and the treatment's tolerability will be closely monitored.
Adverse events, which are any unwanted effects of the treatment, will be recorded and analyzed based on their severity and impact on the body.
Regular medical examinations will be conducted to check vital signs and assess any laboratory abnormalities.
The study will also evaluate the effectiveness of naxitamab in combination with chemotherapy by measuring event-free survival, progression-free survival, overall response rate, and overall survival.
Step 4
Completion of the study
The study is expected to continue until April 30, 2028.
The patient's participation will involve regular follow-ups to monitor their health and the long-term effects of the treatment.

Who can join the trial?

10 criteria

The patient must have a confirmed diagnosis of **Ewing's sarcoma**, which is a type of cancer that affects bones or soft tissues.
If the patient is at puberty or sexually mature, they must agree to use effective birth control during the study and for at least one year after stopping the study treatment.
The patient must have a sample of their tumor available for testing. This sample should be preserved in a specific way called **formalin-fixed, paraffin-embedded (FFPE)**.
The patient must have documented evidence that their disease has gotten worse during or after at least one treatment, or that it has come back after treatment.
The patient's tumor must test positive for a marker called **GD2**, which is checked using a method called **IHC** (immunohistochemistry).
The patient must be between the ages of 2 and 21 years old.
The patient should have a life expectancy of at least 12 weeks from the time they sign the consent form to join the study.
The patient must have finished any previous cancer treatments at least 3 weeks before joining the study, any major surgery at least 2 weeks before, and any radiation therapy at least 4 weeks before.
The patient should have recovered from any side effects of previous surgery, radiation, or cancer treatments, as determined by the study doctor.
The patient or their guardian must sign a consent form agreeing to participate in the study and receive the treatment called **naxitamab**, following current legal rules.

Who cannot join the trial?

8 criteria

Patients who have a different type of cancer other than Ewing's sarcoma cannot participate. Ewing's sarcoma is a type of cancer that affects bones or the soft tissue around bones.
Patients who are not able to safely receive the study treatment due to other health conditions or risks.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have allergies or reactions to the study drugs or similar drugs.
Patients who have certain infections or diseases that could interfere with the study.
Patients who are taking medications that might interfere with the study treatment.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
Wroclaw, Poland

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Naxitamab is being studied for its effectiveness and safety in patients with refractory Ewing's sarcoma. It is being added to the standard chemotherapy regimen to see if it can improve treatment outcomes for these patients.

Naxitamab

What is already known about the treatment

Naxitamab – Naxitamab is administered intravenously, typically as part of a chemotherapy regimen. It is currently being studied in clinical trials for its effectiveness and safety in treating refractory Ewing's sarcoma, a type of bone cancer. The medication works by targeting specific proteins on cancer cells, helping the immune system to recognize and destroy these cells. Naxitamab is classified as a monoclonal antibody, which is a type of targeted cancer therapy.

Investigated diseases

Ewing's sarcoma – Ewing's sarcoma is a rare type of cancer that occurs in bones or in the soft tissue around the bones. It primarily affects children and young adults, often developing in the long bones of the arms and legs, pelvis, or chest. The disease typically begins with pain and swelling in the affected area, which may be mistaken for a sports injury or growing pains. As it progresses, the tumor can cause more severe pain, fever, and fatigue. In some cases, the cancer may spread to other parts of the body, such as the lungs or other bones. Early detection and treatment are crucial to managing the disease effectively.