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Trial Title:
Weekly Irinotecan Liposomes in Recurrent or Refractory Ewing Sarcoma
NCT ID:
NCT06340204
Condition:
Ewing Sarcoma
Conditions: Official terms:
Sarcoma
Sarcoma, Ewing
Irinotecan
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Irinotecan Hydrochloride Liposome Injection
Description:
Irinotecan Hydrochloride Liposome Injection is given weekly by 5 doses every 6 weeks (5/6
qw).
Arm group label:
Adults
Arm group label:
Pediatric
Other name:
duo en yi
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
8 Years
Maximum age:
40 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shandong Cancer Hospital and Institute
Address:
City:
Jina
Zip:
250117
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Dongyuan Zhu, M.D.
Email:
405683898@qq.com
Facility:
Name:
Peking University Shougang Hospital
Address:
City:
Beijing
Zip:
100043
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jin GU, M.D.
Email:
jingu_1999@yahoo.com
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijin
Zip:
100034
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Xu, M.D.
Phone:
+86 15901040835
Email:
xujie@pkuph.edu.cn
Investigator:
Last name:
Xiaodong Tang, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Lu Xie, M.D.
Email:
Sub-Investigator
Start date:
March 25, 2024
Completion date:
December 25, 2026
Lead sponsor:
Agency:
Peking University People's Hospital
Agency class:
Other
Collaborator:
Agency:
Peking University Shougang Hospital
Agency class:
Other
Collaborator:
Agency:
Shandong Cancer Hospital and Institute
Agency class:
Other
Source:
Peking University People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06340204
