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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    45
  • sponsor
    Sarcoma Alliance for Research through Collaboration
Updated on 12 May 2021
measurable disease
irinotecan
refractory ewing sarcoma

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.

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.

Details
Condition Ewing's sarcoma
Treatment Irinotecan, tumor biopsy, Trabectedin 1 MG [Yondelis], 3'-Deoxy-3'-18F Fluorothymidine (18F-FLT) Imaging
Clinical Study IdentifierNCT04067115
SponsorSarcoma Alliance for Research through Collaboration
Last Modified on12 May 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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