SARC037: A Phase I/II Study to Evaluate the Safety of Trabectedin in Combination With Irinotecan in Ewing Sarcoma Patients

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

January 5, 2021

Primary Completion Date

April 24, 2025

Study Completion Date

April 24, 2025

Conditions
Ewing Sarcoma
Interventions
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.

Trial Locations (6)

19104

Children's Hospital of Philadelphia, Philadelphia

19105

University of Pennsylvania, Philadelphia

20892

National Cancer Institute, Bethesda

48106

University of Michigan, Ann Arbor

90027

Children's Hospital of Los Angeles, Los Angeles

02215

Boston Children's Hospital / Dana Farber Cancer Institute, Boston

All Listed Sponsors
collaborator

Janssen Scientific Affairs, LLC

INDUSTRY

collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Cancer Institute (NCI)

NIH

lead

Sarcoma Alliance for Research through Collaboration

OTHER

NCT04067115 - SARC037: A Phase I/II Study to Evaluate the Safety of Trabectedin in Combination With Irinotecan in Ewing Sarcoma Patients | Biotech Hunter | Biotech Hunter