NCT04067115CompletedPhase 1/2
SARC037: A Phase I/II Study to Evaluate the Safety of Trabectedin in Combination With Irinotecan in Ewing Sarcoma Patients
SARC037: A Phase I/II Study to Evaluate the Safety of Trabectedin Administered as a 1-Hour Infusion in Ewing Sarcoma Patients in Combination With Low Dose Irinotecan and 3'-Deoxy-3'-18F Fluorothymidine (18F-FLT) Imaging
Source: ClinicalTrials.gov · Last updated 17 Dec 2025
Brief summary (registry, in English)
This study evaluates the trabectedin and irinotecan in the treatment of Ewings sarcoma, with a EWS-FLI1 mutation. Patients will also receive an infusion of 18F-FLT in combination with a Positron Emission Tomography (PET) scan to help evaluate the effect of treatment.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 37 (actual)
- First submitted
- 21 Aug 2019
- Start date
- 5 Jan 2021
- Primary completion date
- 24 Apr 2025
- Lead sponsor
- Sarcoma Alliance for Research through Collaboration
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT04067115
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 37
- From 5 Jan 2021 to the primary completion date, 24 Apr 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- prior therapy with trabectedin or lurbinectedin
- currently receiving other investigational drugs or anticancer agents
Other illness
- known history of hypersensitivity to irinotecan or topotecan or their excipients.
- known bleeding diathesis
- clinically significant unrelated illness or uncontrolled infection
Other
- known brain metastases
- pregnant or breastfeeding
- unable to comply with the safety monitoring requirements
Who the study is looking for
- diagnosis of relapsed and refractory Ewing sarcoma with EWS-FLI1 fusion type for which there is no known therapy proving to prolong survival
- measurable disease
- ECOG Performance Status of 0-2 or Lansky of 50
- adequate organ function
- written, voluntary consent
- willing to undergo tumor biopsy
- negative hepatitis infection
Age in the registry: 6 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| National Cancer Institute Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| Boston Children's Hospital, Dana-Farber Cancer Institute. Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Children's Hospital of Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
Related publications
- Trabectedin and low-dose irinotecan to target EWS::FLI1 in Ewing sarcoma: a phase 1/2 trial.Nat Med · 2026 · PMID 41991689
This page is information, not medical advice. Discuss any trial with your doctor.