Weekly Irinotecan Liposomes in Recurrent or Refractory Ewing Sarcoma

NCT06340204 | Recruiting Phase 1 DMC

• 1 other identifier: PKUPH-EWS-03
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

Brief Summary

The investigators explored the safety and activity of weekly irinotecan liposomes in patients with relapsed and metastatic Ewing Sarcoma.

Conditions

Ewing Sarcoma

Outcome Measures

Primary Outcomes (1)

• maximum tolerated dose (MTD)

  To evaluate the maximum tolerated dose of weekly irinotecan liposomes for patients with relapsed or refractory Ewing sarcoma.

  6 weeks

Secondary Outcomes (2)

• Objective Response Rate (ORR)

  24 months

• Progression Free Survival (PFS)

  24 months

Study Arms (2)

Pediatric

EXPERIMENTAL

pediatric patients

Drug: Irinotecan Hydrochloride Liposome Injection

Adults

EXPERIMENTAL

Adult patients

Drug: Irinotecan Hydrochloride Liposome Injection

Interventions

Irinotecan Hydrochloride Liposome Injection DRUG

Irinotecan Hydrochloride Liposome Injection is given weekly by 5 doses every 6 weeks (5/6 qw).

Also known as: duo en yi

Adults; Pediatric

Eligibility Criteria

• Age: 8 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Peking University Shougang Hospital: collaborator
• Shandong Cancer Hospital and Institute: collaborator

Study Sites (3)

Shandong Cancer Hospital and Institute

Jina, Shandong, 250117, China

NOT YET RECRUITING

Peking University People's Hospital

Beijin, 100034, China

RECRUITING

Peking University Shougang Hospital

Beijing, 100043, China

NOT YET RECRUITING

MeSH Terms

Conditions

Sarcoma, Ewing

Condition Hierarchy (Ancestors)

Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Head of Musculoskeletal Tumor Center

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: March 25, 2024
• Primary Completion: March 25, 2026
• Study Completion (Estimated): December 25, 2026
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)