Actively Recruiting
Weekly Irinotecan Liposomes in Recurrent or Refractory Ewing Sarcoma
Led by Peking University People's Hospital · Updated on 2024-04-03
44
Participants Needed
3
Research Sites
143 weeks
Total Duration
On this page
Sponsors
P
Peking University People's Hospital
Lead Sponsor
P
Peking University Shougang Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The investigators explored the safety and activity of weekly irinotecan liposomes in patients with relapsed and metastatic Ewing Sarcoma.
CONDITIONS
Official Title
Weekly Irinotecan Liposomes in Recurrent or Refractory Ewing Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed Ewing sarcoma
- Evidence of Ewing sarcoma translocation by fluorescence in situ hybridization (FISH) or real-time polymerase chain reaction (RT-PCT)
- Recurrent or refractory tumors with no known curative treatment options as judged by the investigator
- Prior treatment with standard chemotherapy agents including doxorubicin, vincristine, cyclophosphamide, ifosfamide, and etoposide
- Metastatic relapsed and unresectable progressive disease
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group performance status 0-1
- Measurable disease on CT or MRI by RECIST 1.1
- Adequate organ function
- At least 3 weeks since last systemic therapy, 2 weeks since radiation therapy or major surgery
- Recovery from toxicities after autologous hematopoietic stem cell transplantation
- At least 6 months after allogeneic hematopoietic stem cell transplantation with no active graft-versus-host disease and no immunosuppressive treatment for at least 30 days
- For patients with central nervous system disease: prior radiotherapy or surgery, off glucocorticoids for at least 4 weeks, no neurological deficits, and at least 6 weeks post brain irradiation
- Females of childbearing potential and males with partners agree to use effective contraception during the study and for 6 months after last dose
You will not qualify if you...
- Clinically significant unrelated illness that may affect ability to tolerate treatment or interfere with study
- Baseline corrected QT interval (QTc) greater than 480 msec
- Known hypersensitivity to irinotecan liposome components or prior hypersensitivity to this drug class
- Use of other investigational or anticancer agents during the study
- Pregnancy or breastfeeding; females capable of pregnancy must have negative pregnancy test within 7 days before first dose
- Diagnosis of other significant malignant disease within the past 5 years except certain non-invasive cancers
- Persistent grade 2 or higher neutropenia or thrombocytopenia, or grade 3 or higher anemia from prior cancer therapy lasting more than 4 weeks
- Presence of other simultaneous malignant tumors
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Shandong Cancer Hospital and Institute
Jina, Shandong, China, 250117
Not Yet Recruiting
2
Peking University People's Hospital
Beijin, China, 100034
Actively Recruiting
3
Peking University Shougang Hospital
Beijing, China, 100043
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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