MedTrace Logo

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

NCT04067115 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-12-17

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Janssen Scientific Affairs, LLC

    collaborator INDUSTRY

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • Sarcoma Alliance for Research through Collaboration

    lead OTHER

Principal Investigators

  • Patrick Grohar, MD/PhD · Children's Hospital of Philadelphia

  • John Glod, MD/PhD · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
6 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-05
Primary Completion
2025-04-24
Completion
2025-04-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04067115 on ClinicalTrials.gov