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New treatment option for Ewing Sarcoma
Official title Weekly Irinotecan Liposomes in Recurrent or Refractory Ewing Sarcoma
ClinicalTrials.gov ID: NCT06340204
What this study is testing
What is Irinotecan Hydrochloride Liposome Injection?
Irinotecan Hydrochloride Liposome Injection is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for ewing sarcoma.
Also referred to as duo en yi.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The investigators explored the safety and activity of weekly irinotecan liposomes in patients with relapsed and metastatic Ewing Sarcoma.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 40
You may be able to join if
- 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...
- Life expectancy of ≥ 3 months.
You likely can't join if
- Clinically significant unrelated illness which would, in the judgment of the treating physician, compromise the patient's ability to tolerate the...
- 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. people capable of pregnancy (post menarche and not post-menopausal, defined as over 12 months...
- Other clinically significant malignant disease diagnosed within the previous 5 years, excluding intra-epithelial cervical neoplasia or non-melanoma...
See the full eligibility 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...
- 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...
- 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.
- 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...
- 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. people capable of pregnancy (post menarche and not post-menopausal, defined as over 12 months since final menstrual period) must have a negative pregnancy test...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jina, Shandong, China
- Beijin, China
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jina, Shandong, China; Beijin, China; Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.