NCT04067115

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Sarcoma Alliance for Research through Collaboration · Academic / Other
• Sex: All
• Age: 6 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Trabectedin and Irinotecan may inhibit the activity of this Ewing sarcoma mutation. Trabectedin may suppress the proliferation of the gene involved in DNA damage response. It blocks EWS-FLI1 by inactivating the fusion protein and silences the target genes. Irinotecan also suppresses the genes regulating the tumor cells, generating DNA damage. Together, these drugs work in combination to suppress the gene regulating the tumor cells. This combination may suppress the activity of the tumor regulating genes, disrupting the activity of the genes. The infusion of 18F-FLT in combination with a Positron Emission Tomography (PET) scan will demonstrate whether the target cells have been suppressed.

Conditions

• Ewing Sarcoma

Interventions

Type	Name	Description
DRUG	Trabectedin 1 MG [Yondelis]	Patients with Ewing sarcoma will be administered trabectedin intravenously. Cycles are 21 days.
DRUG	Irinotecan	Patients with Ewing sarcoma will be administered inirotecan intravenously. Cycles are 21 days.
DIAGNOSTIC_TEST	tumor biopsy	Tumor tissue samples will be collected collected at two timepoints. The first biopsy will be prior to treatment. If a biopsy is not possible archival tissue may be submitted. A second tumor biopsy will be taken fro consenting patients when possible after the first administration of Trabectedin to evaluate the effect on the tumor cells.
OTHER	3'-Deoxy-3'-18F Fluorothymidine (18F-FLT) Imaging	Some patients will receive PET scans with the use of 18F-FLT, a radioactive tracer, performed at the National Institute of Health.

Timeline

• Start date: 2021-01-05
• Primary completion: 2025-04-24
• Completion: 2025-04-24
• First posted: 2019-08-26
• Last updated: 2025-12-17

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study