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SARC037: A Phase I/II Study to Evaluate the Safety of Trabectedin in Combination With Irinotecan in Ewing Sarcoma Patients
Trial Status: complete
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.
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04067115.
Locations matching your search criteria
United States
California
Los Angeles
Children's Hospital Los Angeles
Status: Active
Name Not Available
Pennsylvania
Philadelphia
Children's Hospital of Philadelphia
Status: Active
Name Not Available
University of Pennsylvania/Abramson Cancer Center
Status: Active
Name Not Available
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.
Trial PhasePhase I/II
Trial Typetreatment
Lead OrganizationSarcoma Alliance for Research Through Collaboration
