The investigators explored the safety and activity of weekly irinotecan liposomes in patients with relapsed and metastatic Ewing Sarcoma.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Irinotecan Hydrochloride Liposome Injection is given weekly by 5 doses every 6 weeks (5/6 qw).
Shandong Cancer Hospital and Institute
Jina, Shandong, China
NOT_YET_RECRUITINGPeking University People's Hospital
Beijin, China
RECRUITINGPeking University Shougang Hospital
Beijing, China
NOT_YET_RECRUITINGmaximum tolerated dose (MTD)
To evaluate the maximum tolerated dose of weekly irinotecan liposomes for patients with relapsed or refractory Ewing sarcoma.
Time frame: 6 weeks
Objective Response Rate (ORR)
To assess the preliminary response rate of irinotecan liposomes in patients with relapsed or refractory Ewing sarcoma.
Time frame: 24 months
Progression Free Survival (PFS)
To assess the preliminary progression free survival of irinotecan liposomes in patients with relapsed or refractory Ewing sarcoma.
Time frame: 24 months
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