Actively Recruiting
Clinical Study in Adult and Young Adult Patients With Advanced Desmoplastic Small Round Cell Tumor (DSRCT) ISG-TULIPS
Led by Italian Sarcoma Group · Updated on 2026-04-03
20
Participants Needed
1
Research Sites
253 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Study in Adult and Young Adult Patients With Advanced Desmoplastic Small Round Cell Tumor (DSRCT) ISG-TULIPS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of DSRCT confirmed by EWSR1-WT1 translocation
- Age 15 years or older
- Locally advanced or metastatic disease not suitable for radical surgery
- Measurable disease by RECIST v1.1
- Disease progression after last standard therapy or stopped therapy due to intolerance within 6 months
- Prior treatment with at least one anthracycline-based chemotherapy and no more than 3 chemotherapy lines
- ECOG Performance Status of 0, 1, or 2
- Adequate bone marrow, kidney, liver, and metabolic function as defined by specified laboratory values
- Cardiac ejection fraction of 50% or higher
- Recovery to grade 1 or baseline from previous treatment adverse events (except specified exceptions)
- No history of arterial or venous thromboembolic events in the past 12 months
- Negative pregnancy test for females of childbearing potential
- Post-menopausal women must be amenorrheic for at least 12 months
- Agree to use highly effective contraception during study and specified time after last treatment
- Ability to understand and provide written informed consent
You will not qualify if you...
- Prior treatment with lurbinectedin, trabectedin, Ecubectedin (PM 14), or PM54
- Known allergy to irinotecan, lurbinectedin, or their components
- Other primary cancer within 5 years except certain low-risk cancers
- Unstable angina, recent heart attack, or significant heart valve disease within 12 months
- Severe heart failure or uncontrolled arrhythmias within 12 months
- Persistent high creatine phosphokinase levels
- Severe or uncontrolled medical diseases such as uncontrolled diabetes or infections
- Active brain metastases
- Chronic active hepatitis or liver cirrhosis
- HIV, hepatitis C infection, or active hepatitis B
- Chronic inflammatory colon or liver diseases or past intestinal obstructions
- Symptomatic pulmonary fibrosis or rapidly worsening pleural or cardiac effusion
- Other major illnesses increasing participation risk as judged by investigator
- Active COVID-19 infection
- Prior bone marrow or stem cell transplantation
- Recent systemic cytotoxic or investigational therapy within 21 days
- Radiation therapy within 14 days
- Recent major or minor surgery within specified time frames
- Use of strong CYP3A inducers within two weeks before first lurbinectedin dose
- Limitations preventing study compliance
- Current active liver or biliary disease except specified stable conditions
- Known Gilbert's syndrome
- Live or live attenuated vaccine within 30 days before first study dose (killed vaccines allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, MI, Italy, 20133
Actively Recruiting
Research Team
G
Gianluca Ignazzi
CONTACT
V
Viviana Appolloni
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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