Weekly Irinotecan Liposome Treatment for Patients Aged 8 to 40 With Relapsed or Refractory Ewing Sarcoma

What this Trial Is About

Researchers are studying the safety and activity of weekly irinotecan liposome injections in patients with relapsed and metastatic Ewing Sarcoma, a condition with poor prognosis after standard therapy. This phase 1 dose-finding study uses a Bayesian Optimal Interval design to explore treatment in patients who have failed first-line chemotherapy including doxorubicin, vincristine, cyclophosphamide, ifosfamide, and etoposide. Participants receive Irinotecan Hydrochloride Liposome Injection weekly, with 5 doses administered every 6 weeks. This liposomal form may stay longer in the body and offers a more convenient weekly schedule compared to traditional irinotecan infusion. Both pediatric and adult patients are included, with treatment tailored to their condition and monitored closely. During the study, participants undergo regular assessments including CT or MRI scans to measure tumor response by RECIST 1.1 criteria. Researchers will monitor the maximum tolerated dose over 6 weeks and track response rates and progression-free survival up to 24 months. Safety evaluations and organ function tests are conducted throughout, with follow-up visits scheduled to observe treatment effects and tolerability.

Weekly Irinotecan Liposomes in Recurrent or Refractory Ewing Sarcoma