Weekly irinotecan liposomes for Ewing Sarcoma
Weekly Irinotecan Liposomes in Recurrent or Refractory Ewing Sarcoma
This study tests if a new way of giving irinotecan, using liposomes, can help people with tough cases of Ewing Sarcoma feel better and improve their treatment results.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 8 Years to 40 Years |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation, cyclophosphamide, doxorubicin |
| Locations | 3 sites (Jina, Shandong and 2 other locations) |
| Trial ID | NCT06340204 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and effectiveness of weekly irinotecan liposomes in patients with recurrent or refractory Ewing Sarcoma who have not responded to standard chemotherapy. The study aims to improve the quality of life and treatment outcomes by utilizing a more convenient dosing schedule compared to traditional irinotecan administration. Using a Bayesian Optimal Interval design, the trial will assess the anti-tumor activity of the liposomal formulation, which may offer prolonged circulation time and enhanced efficacy. Participants will be closely monitored for safety and response to treatment.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed Ewing Sarcoma who have experienced disease recurrence or progression after standard chemotherapy.
Not a fit: Patients with curable Ewing Sarcoma or those who have not yet undergone first-line chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, more effective option for patients with limited treatment choices for Ewing Sarcoma.
How similar studies have performed: Previous studies have shown promising results with irinotecan in Ewing Sarcoma, but the use of liposomal formulations in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 according to the judgment of the investigator. * Prior treatment consisted of standard Ewing Sarcoma chemotherapy agents including doxorubicin, vincristine, cyclophosphamide, ifosfamide and etoposide; metastatic relapsed and unresectable progressive disease (PD). * Life expectancy of ≥ 3 months. * Eastern Cooperative Oncology Group performance status 0-1. * Measurable disease on CT or MRI by RECIST 1.1. * Adequate organ function. * Time elapsed from previous therapy must be ≥ 3 weeks for systemic therapy, ≥ 2 weeks for radiation therapy or major surgery. * Patients who have undergone autologous hematopoietic stem cell transplantation are eligible once they have recovered from all toxicities from therapy. * Patients who have received allogeneic hematopoietic stem cell transplantation will be eligible 6 months after the procedure provided there is no evidence of active graft-versus-host disease and immunosuppressive treatment has been discontinued for at least 30 days. * Patients with central nervous system disease are eligible for enrollment if they have received prior radiotherapy or surgery to sites of central nervous system metastatic disease, have been off glucocorticoids for at least 4 weeks, have no overt evidence of neurological deficit and are ≥ 6 weeks from completion of brain irradiation. * Females of childbearing potential as well as males and their partners must agree to use an effective form of contraception during the study and for 6 months following the last dose of study medication. Exclusion Criteria: * Clinically significant unrelated illness which would, in the judgment of the treating physician, compromise the patient's ability to tolerate the investigational agent or be likely to interfere with the study procedures or results. * Patients with baseline corrected QT interval(QTc) \> 480 msec. * Known hypersensitivity to any of the components of irinotecan liposomes or prior hypersensitivity reactions to that class of drugs. * Concomitant use of any other investigational or anticancer agent(s). * Pregnant patients or patients who are breast feeding. Subjects capable of pregnancy (post menarche and not post-menopausal, defined as over 12 months since final menstrual period) must have a negative pregnancy test within 7 days prior to first dose. * Other clinically significant malignant disease diagnosed within the previous 5 years, excluding intra-epithelial cervical neoplasia or non-melanoma skin cancer. * Known persistent (\> 4 weeks) ≥ Grade 2 neutropenia, ≥ Grade 2 thrombocytopenia or \> Grade 3 anemia from prior cancer therapy. * Other kinds of malignant tumors at the same time.
Where this trial is running
Jina, Shandong and 2 other locations
- Shandong Cancer Hospital and Institute — Jina, Shandong, China (Not_yet_recruiting)
- Peking University People's Hospital — Beijin, China (Recruiting)
- Peking University Shougang Hospital — Beijing, China (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.