Prospective Identification of Predictive Biomarkers of Trabectedin Efficacy in Non-L Soft-tissue Sarcoma Patients (PIPER)

  • STATUS
    Recruiting
  • End date
    Jan 22, 2023
  • participants needed
    200
  • sponsor
    Institut Bergonié
Updated on 22 March 2022
metastases
measurable disease
metastasis
desmoplastic
trabectedin
liposarcoma
hemangioendotheliomas
leiomyosarcoma
epithelioid sarcoma

Summary

This is a biology driven, monocentric study, designed to identify biomarkers of activity of trabectedin in patients with advanced non-L soft-tissue sarcoma. The aim of this study is to implement high-throughput profiling technologies to identify predictive biomarkers of trabectedin efficacy through sequential tumor biopsies and blood sample collection in sarcoma patients.

Description

The identification of predictive biomarkers of the clinical benefit of trabectedin is a crucial issue to identify potential responders particularly for non-L sarcomas. Considering that the molecular profile of STS can change over time, an analysis of archival tumor material may not be a reliable method to identify predictive biomarkers of response, and thus high-throughput technologies may be promising to identify STS markers for prediction of response to trabectedin. For study purpose, blood and tumor samples will be obtained for genetic and immunological profiling at baseline, during treatment by trabectedin and at disease progression.

Details
Condition Soft Tissue Sarcoma Adult, Undifferentiated Pleomorphic Sarcoma, Epithelioid Sarcoma, Solitary Fibrous Tumors, Hemangioendothelioma, Desmoplastic Round Cell Tumor, Synovial Sarcoma
Treatment trabectedin
Clinical Study IdentifierNCT04008238
SponsorInstitut Bergonié
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥ 18 years
Histology: undifferentiated pleomorphic sarcomas, epithelioid sarcomas, solitary fibrous tumors, hemangioendothelioma, desmoplastic round cell tumors, synovial sarcomas or other non-leiomyosarcoma/non-liposarcoma softtissue sarcoma. As per the Frech NCI recommendation, diagnosis must be reviewed or confirmed by the RRePS Network (Réseau de Référence en Pathologie des Sarcomes des tissus mous et des Viscères)
Locally advanced/unresectable and/or metastatic disease
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Appendix 1)
Measurable disease according to RECIST v1.1
Indication of trabectedin according to market authorization
At least one target lesion that can be biopsied for research
Women of childbearing potential must have a negative serum pregnancy test before study entry
Patient with a social security in compliance with the French law
Voluntary signed and dated written informed consent prior to any study specific procedure
Women must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of trabectedin. Men must agree to use a medically acceptable method of contraception throughout the treatment period and for 5 months after discontinuation of trabectedin. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for >=1 year

Exclusion Criteria

Previous treatment with trabectedin
Known hypersensitivity to any of its components
Patients with an active serious or uncontrolled infection upon investigator judgement
Radiological evidence of symptomatic or progressive brain metastases
Abnormal coagulation contraindicating biopsy
Any medical and/or biological contra-indication to treatment by trabectedin as per market authorization specification (as per investigator judgement)
Patients unable to receive corticotherapy
Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin and prostate cancer
Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension, active bleeding diatheses, or active Hepatitis B, C and HIV)
Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol
Individuals deprived of liberty or placed under guardianship
Pregnant or breast feeding women
Previous enrolment in the present study
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