RecruitingPhase 2NCT07328425

Clinical Study in Adult and Young Adult Patients With Advanced Desmoplastic Small Round Cell Tumor (DSRCT) ISG-TULIPS

Phase II Study of Lurbinectedin and Irinotecan in Adult and Young Adult Patients With Advanced Desmoplastic Small Round Cell Tumor (DSRCT)

Sponsor

Italian Sarcoma Group

Enrollment

20 participants

Start Date

Nov 21, 2025

Study Type

INTERVENTIONAL

Conditions

Desmoplastic Small Round Cell Tumor

Summary

Patients participating in this study have DSRCT that has spread locally or to other parts of the body and can no longer be surgically removed without causing significant harm. Treatment will continue until the tumor progresses further, severe side effects occur, or either patient or investigator decision. In addition, patients may participate in an optional biological study. The study will analyze the tumor's genes and the molecules related to them. By studying genes and their products, the investigators can better understand the behavior of the tumor and how the body responds to therapies.

Eligibility

Min Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment for desmoplastic small round cell tumor (DSRCT) — a very rare and aggressive cancer that typically affects the abdomen of young people. Because there are so few effective treatments, this study is evaluating a new therapy in patients whose disease has progressed after standard chemotherapy. **You may be eligible if...** - You are 15 or older - Your tumor has been confirmed as DSRCT by a specialist lab with a specific genetic marker (EWSR1-WT1 translocation) - Your cancer cannot be surgically removed, has spread to other sites, or has progressed after standard treatments - You have had at least one prior chemotherapy regimen containing an anthracycline drug, and no more than 3 prior chemotherapy lines - Your cancer has measurable tumors on imaging - Your blood counts and organ function are in acceptable ranges **You may NOT be eligible if...** - You have not had prior chemotherapy for DSRCT - You have had more than 3 prior chemotherapy regimens - You are in poor overall health (ECOG performance status above 2) - Your blood counts or organ function are below acceptable thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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