Overview

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

Status:
Recruiting

Trial end date:
2023-06-30

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Sarcoma Alliance for Research through Collaboration

Collaborators:

Janssen Scientific Affairs, LLC
National Cancer Institute (NCI)
National Institutes of Health (NIH)

Treatments:

Alovudine
Irinotecan
Trabectedin

Criteria

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