Clinical trial · Interventional
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
NCT04067115CI-TRIAL-00099110U01CA236220completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ewing Sarcoma | Ewing Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3'-Deoxy-3'-18F Fluorothymidine (18F-FLT) Imaging | Other | — | UNRESOLVED |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Trabectedin 1 MG [Yondelis] | Drug | Trabectedin | ALIAS |
| tumor biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trabectedin and Irinotecan
- description
- Trabectedin will be delivered by infusion on day 1 followed by 2 doses on irinotecan delivered by infusion for one hour on day 2 and day 4 of 21 day cycles. Some patients will receive an 18F-FLT Imaging scan prior to the first administration of trabectedin and once after administration of trabectedin.
- interventionNames
- Drug: Trabectedin 1 MG [Yondelis]
- Drug: Irinotecan
- Diagnostic Test: tumor biopsy
- Other: 3'-Deoxy-3'-18F Fluorothymidine (18F-FLT) Imaging
Primary outcomes (3)
- measure
- Phase I The recommended dose (RD) of trabectedin administered in combination with low dose irinotecan
- timeFrame
- up to 36 months
- description
- The recommended dose will be established by enrolling patients at the lowest dose and observing them for dose limiting toxicity. Dose limiting toxicity describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. The maximum tolerated dose is the highest dose of a drug or treatment that does not cause unacceptable side effects. If 0 of the first 3 subjects experience DLT, the study will proceed to the next dose level. If 1 subject experiences a DLT, that dose level cohort will be expanded to 6 total subjects. If no additional subjects experience DLTs at that dose level cohort, the study will proceed to enroll the next dose level cohort. If ≥ 2 of 6 subjects experience DLT, then that dose level is the recommended dose of trabectedin (RD). The study will proceed to the same process for the irinotecan escalation. If 2 or all 3 subjects experience DLT, that dose level is the recommended dose of trabectedin (RD).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * prior therapy with trabectedin or lurbinectedin * known history of hypersensitivity to irinotecan or topotecan or their excipients. * known brain metastases * known bleeding diathesis * pregnant or breastfeeding * currently receiving other investigational drugs or anticancer agents * clinically significant unrelated illness or uncontrolled infection * unable to comply with the safety monitoring requirements
References
Publications (1)
- DERIVEDGrohar PJ, Heise R, Wedekind MF, Ballman K, Mascarenhas L, DuBois SG, Maki RG, Boguslawski EA, Gedminas JM, Wilson ER, Thomas E, Segers B, Surrey LF, Ricker C, Klega K, Navid F, Lam GY, The S, Kaufman R, Roberts RD, Hayashi M, Mena E, Overman L, Peer C, Schmidt K, Diamond MS, Figg WD, Bagatell R, Liza Lindenberg M, Choyke PL, Crompton BD, Widemann BC, Glod JW, Laetsch TW, Reinke DK, Chugh R. Trabectedin and low-dose irinotecan to target EWS::FLI1 in Ewing sarcoma: a phase 1/2 trial. Nat Med. 2026 Jun;32(6):2227-2237. doi: 10.1038/s41591-026-04340-7. Epub 2026 Apr 16. PMID 41991689