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

Sponsor
Italian Sarcoma Group
Study ID
NCT07328425
Phase
PHASE2
Status
Recruiting
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Conditions

  • Desmoplastic Small Round Cell Tumor

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 21, 2025
Status verified
Jun 2026
Primary completion
Oct 1, 2030
Completion
Oct 1, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lurbinectedine and Irinotecan
    lurbinectedin in combination with intravenous irinotecan administered until progression or unacceptable toxicity, in a population of =/\>15 years old patients with histologically and molecularly confirmed (EWSR1-WT1 translocation positive), advanced (locally advanced or metastatic) DSRCT, from 2nd to 4th line, following progression to anthracycline-based chemotherapy.

Primary Outcome Measure

Overall tumour Response Rate (ORR), according to RECIST v 1.1 [ Time Frame: Week 6, week 12, week 18, week 30, week 42, week 54, week 66, week 78, week 90, week 102 and until progression ]

Central Contacts

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