Health TrialsbyHealthPanel

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

ConditionDesmoplastic Small Round Cell Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age15+
SponsorItalian Sarcoma Group

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Histological centrally confirmed diagnosis of DSRCT with the documented presence of EWSR1-WT1 translocation.

Age ≥ 15 years.

Locally advanced (i.e. radical surgical resection of local disease unfeasible or surgery declined by the patient or surgery deemed to become less demolitive and / or easier after cytoreduction) and/or metastatic disease.

Measurable disease by RECIST v1.1.

Disqualifiers

Prior treatment with lurbinectedin or trabectedin, Ecubectedin (PM 14) or PM54.

Known hypersensitivity to irinotecan or lurbinectedin or any of their components of the drugs products (excipients).

Other primary malignancy with <5 years clinically assessed disease free interval, except basal cell skin cancer, cervical carcinoma in situ or other neoplasm judged to entail a low risk of relapse.

History or presence of unstable angina, myocardial infarction, or clinically significant valvular heart disease within 12 months of the study.

Trial design

Design model

Single group

Treatments tested in this trial

  • Lurbinectedin

    Drug

    Lurbinectedin and Irinotecan

  • Irinotecan

    Drug

    Lurbinectedin and Irinotecan

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Lurbinectedine and IrinotecanExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall tumour Response Rate (ORR), according to RECIST v 1.1

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

Secondary outcomes

1

Overall Survival (OS)

Overall Survival (OS)

Time frame
From date of study therapy start until the date of death from any cause, assessed up to 60 months
2

Progression Free Survival (PFS)

Progression Free Survival (PFS)

Time frame
From date of study therapy start until first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
3

Duration of Response (DoR)

Duration of Response (DoR)

Time frame
From date of study therapy start until first documented assessment without progression or date of death from any cause, whichever came first, assessed up to 60 months
4

Adverse events and Serious adverse event (according to CTC-AE v.5)

Adverse events and Serious adverse event (according to CTC-AE v.5)

Time frame
After initiation of study treatments(s), all adverse events will be reported until 30 days after the final dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Italian Sarcoma Group

Lead sponsor

Source ClinicalTrials.gov
Apply now