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

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What is this study about?

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country	Status
Instytut Matki I Dziecka	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	01.05.2023

Trial locations

Investigated drugs:

Naxitamab

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.

Investigated diseases:

Ewing's sarcoma

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.

Trial ID:

2024-514441-11-00

Protocol code:

BUTTERFLY

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?