Spots Global Cancer Trial Database for Weekly Irinotecan Liposomes in Recurrent or Refractory Ewing Sarcoma
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Trial Identification
Brief Title: Weekly Irinotecan Liposomes in Recurrent or Refractory Ewing Sarcoma
Official Title: Weekly Irinotecan Liposomes in Recurrent or Refractory Ewing Sarcoma
Study ID: NCT06340204
Conditions
Interventions
Study Description
Brief Summary: The investigators explored the safety and activity of weekly irinotecan liposomes in patients with relapsed and metastatic Ewing Sarcoma.
Detailed Description: After standard multimodal therapy, the prognosis of relapsed and metastatic Ewing Sarcoma is dismal and unchanged over the last decades. The anti-tumor activity of irinotecan was demonstrated by several studies in the past. However, longer schedule of irinotecan infusion (traditionally dx5x2) has impacted quality of life in these patients. The irinotecan liposomes may be more active than the parent compound irinotecan since its ability to stay longer in circulation system, and much more convenient to given weekly. Thus, the investigators explored the safety and activity of weekly irinotecan liposomes in patients with relapsed and metastatic Ewing Sarcoma after the failure of first-line chemotherapy with doxorubicin, vincristine, cyclophosphamide, ifosphamide and etoposide. Bayesian Optimal Interval (BOIN) design is adopted in this dose-finding study.
Keywords
Eligibility
Minimum Age: 8 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Shandong Cancer Hospital and Institute, Jina, Shandong, China
Peking University Shougang Hospital, Beijing, , China
Peking University People's Hospital, Beijin, , China
Contact Details
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