RecruitingPhase 2NCT05968768

To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma (Butterfly)

To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma

Sponsor

Anna Raciborska

Enrollment

24 participants

Start Date

Oct 24, 2023

Study Type

INTERVENTIONAL

Conditions

Ewing Sarcoma

Summary

Prospective, interventional, open, randomized, national, multicenter, non-commercial trial

Eligibility

Min Age: 2 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study (called Butterfly) is testing a drug called naxitamab in young patients with Ewing's sarcoma — a rare type of bone and soft tissue cancer — that has come back or stopped responding to standard treatment. Naxitamab is an antibody that targets a protein called GD2, which is found on the surface of Ewing's sarcoma cells, and helps the immune system attack those cells. **You may be eligible if...** - You are between 2 and 21 years old - You have a confirmed diagnosis of Ewing's sarcoma that has progressed or relapsed after at least one prior treatment - Your tumor tests positive for the GD2 protein - Your life expectancy is at least 12 weeks - You have recovered from side effects of any previous treatment - A tissue sample from your tumor is available for testing **You may NOT be eligible if...** - You have previously been treated with an anti-GD2 antibody - You have a known allergy to naxitamab or components of the treatment - You are receiving another experimental drug - You are pregnant or of reproductive age without effective contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNaxitamab

Naxitamab will be used only in a hospital setting and must be administered under the supervision of a doctor with experience in the use of oncological therapies. The medicinal product must be administered by a healthcare professional prepared to deal appropriately with severe allergic reactions, including anaphylaxis, in an environment that provides immediate, full access to resuscitation. The patient should have 2 well-functioning IV accesses before any naxitamab treatment is initiated. The solution should be administered through a peripheral or central intravenous catheter. Other concomitant intravenous medicinal products should be administered through separate intravenous access. Before the start of each infusion, premedication will be carried out.