Recruiting
Phase 2
To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma (Butterfly)
Condition(s) studied
Ewing Sarcoma
Investigational drug(s) / intervention(s)
Naxitamab: 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.
Study summary
Prospective, interventional, open, randomized, national, multicenter, non-commercial trial
Eligibility
Inclusion Criteria:
1. Histologically proven Ewing sarcoma of the bone or soft tissues.
2. Subject's archival tumour sample (formalin-fixed, paraffin-embedded; FFPE) available for evaluation of GD2 expression.
3. Documented disease progression (during or after completion of at least one line treatment) or any subsequent recurrence.
4. GD2 positive tumor assessed by IHC.
5. Age ≥ 2 years and ≤ 21 years.
6. Life expectancy of at least 12 weeks from the time informed consent was signed.
7. Previous systemic anticancer treatment completed ≥ 3 weeks, major surgery ≥ 2 weeks, and radiation therapy ≥ 4 weeks prior to study enrollment.
8. Recovered from adverse effects of prior surgery, radiotherapy, or Clinical trial protocol BUTTERFLY version 1.0 of 30.09.2022 r.anti-neoplastic therapy at the discretion of the investigator.
9. Signing of informed consent for trial participation (including for naxitamab treatment) according with current legal regulations.
10. Consent to the use of effective contraception throughout the period of the study and a minimum of 1 year after discontinuation of study treatment in patients at puberty and sexual maturity
Exclusion Criteria:
1. Failure to meet any of the inclusion criteria.
2. Not eligible to IT.
3. Previous treatment with an anti-GD2 antibody.
4. Hypersensitivity to the study drugs or any of their ingredients (covers IT and naxitamab).
5. Simultaneous treatment with other drugs which might interact with naxitamab or IT regimen.
6. Persistent toxicity related to prior therapy, making it impossible to treat with naxitamab.
7. Significant cardiac conduction abnormalities, including known familial prolonged QT syndrome, or screening corrected QT interval (QTc) \>480 msec.
8. Symptoms of congestive heart failure or left ventricular ejection fraction \<50%.
9. Inadequate pulmonary function defined as evidence of dyspnea at rest, exercise intolerance, and/or chronic oxygen requirement. In addition, room air pulse oximetry \< 94% and/or abnormal pulmonary function tests if these assessments are clinically indicated.
10. Requirement, or likely requirement, for corticosteroids at doses \>10 mg prednisolone (or equivalent) per day or other immunosuppressive agents.
11. Diagnosis of other malignancies before study inclusion.
12. Planning to become pregnant (while being treated with IT or naxitamab), pregnancy or breastfeeding.
13. Other acute or persistent disorders, behaviors or abnormal laboratory test results, which might increase the risk related to the participation in this clinical trial or to taking the study drug, or which might influence the interpretation of the study results, or which, in the investigator's opinion, disqualify a patient from participating in the tri
Primary outcome measure(s)
- Safety assessment of the addition of naxitamab to standard 3-week chemotherapy (CHT) in patients with refractory Ewing's sarcoma (ES) — up to 240 days
Safety will be assessed by number of serious adverse events (SAE), by the number of adverse events (AE), by medical examination with the analysis of recorded vital signs, laboratory abnormalities according to NCI CTCAE v5.0
Trial sites (2)
| Facility | City | Region | Status |
|---|
| Mother and Child Institute |
Warsaw |
Mazowian |
Recruiting |
| Wroclaw Medical University |
Wroclaw |
Poland |
Not Yet Recruiting |
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