Actively Recruiting
To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma (Butterfly)
Led by Anna Raciborska · Updated on 2025-04-10
24
Participants Needed
2
Research Sites
248 weeks
Total Duration
On this page
Sponsors
A
Anna Raciborska
Lead Sponsor
W
Wroclaw Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Prospective, interventional, open, randomized, national, multicenter, non-commercial trial
CONDITIONS
Official Title
To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma (Butterfly)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven Ewing sarcoma of the bone or soft tissues.
- Availability of archival tumor tissue for GD2 expression evaluation.
- Documented disease progression during or after at least one prior treatment or subsequent recurrence.
- Tumor confirmed GD2 positive by immunohistochemistry.
- Age between 2 and 21 years.
- Life expectancy of at least 12 weeks from signing informed consent.
- Previous systemic anticancer treatment completed at least 3 weeks prior to enrollment.
- Major surgery completed at least 2 weeks prior to enrollment.
- Radiation therapy completed at least 4 weeks prior to enrollment.
- Recovery from adverse effects of prior treatments as determined by the investigator.
- Signed informed consent for trial participation including naxitamab treatment.
- Consent to use effective contraception during the study and for at least one year after treatment in patients at puberty or sexual maturity.
You will not qualify if you...
- Failure to meet any inclusion criteria.
- Not eligible for irinotecan and temozolomide treatment.
- Previous treatment with an anti-GD2 antibody.
- Hypersensitivity to study drugs or their ingredients.
- Simultaneous treatment with drugs that may interact with naxitamab or chemotherapy.
- Persistent toxicity from prior therapy making naxitamab treatment impossible.
- Significant cardiac conduction abnormalities or prolonged QT interval over 480 msec.
- Symptoms of heart failure or left ventricular ejection fraction below 50%.
- Inadequate lung function including dyspnea at rest, exercise intolerance, oxygen requirement, or low oxygen saturation.
- Requirement or likely need for corticosteroids over 10 mg prednisolone daily or other immunosuppressive agents.
- Diagnosis of other malignancies before study inclusion.
- Pregnancy, breastfeeding, or planning to become pregnant during treatment.
- Other acute or persistent disorders, behaviors, or lab abnormalities that increase risk or affect study results, as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Mother and Child Institute
Warsaw, Mazowian, Poland, 01-211
Actively Recruiting
2
Wroclaw Medical University
Wroclaw, Poland, 50-556
Not Yet Recruiting
Research Team
A
Anna Raciborska, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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