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Phase 2 Study for Leiomyosarcoma Treatment

This study is testing a combination of three medications – Trabectedin, Gemcitabine, and Dacarbazine – for people with leiomyosarcoma, a type of soft tissue sarcoma. These drugs are given intravenously (into a vein) in a specific way called "metronomic dosing." The study is looking to see how long patients live without their cancer getting worse (progression-free survival) at 12 months. You may be able to join if you are at least 18 years old, have leiomyosarcoma that has spread or cannot be removed, and have already received treatment for it. The study aims to enroll 80 participants. The current status of this study is unclear.

Study design
This is an open-label, Phase 2 study involving 80 participants. All participants will receive the same combination of medications.
What's involved
You would receive Trabectedin, Gemcitabine, and Dacarbazine intravenously on Day 1 and Day 8 of a 3-week cycle. Treatment may continue for up to one year, or until your disease progresses significantly or side effects become too severe.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, progression-free survival, is measured at 12 months. Patients may continue treatment for up to one year.

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NCT04535271

Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Soft Tissue Sarcoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Sarcoma Oncology Research Center, LLC
~80 participants
Updated 2025-02-24 on ClinicalTrials.gov
What's tested:Trabectedin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival
Measured over 12 months

Conditions

Leiomyosarcoma

Explore related trials

Leiomyosarcoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Sant P Chawla, MD · PRINCIPAL_INVESTIGATOR · Sarcoma Oncology Research Center, LLC

Who to contact

Sant P Chawla, MD
[email protected]
3105529999
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or Female ≥ 18 years of age
Pathologically confirmed diagnosis of locally advanced, unresectable or metastatic leiomyosarcoma
Previously treated patient with measurable disease by RECIST v1.1
ECOG performance status ≤ 2
Life expectancy of at least 3 months
Acceptable liver function: Bilirubin \< 1.5 times upper limit of normal (ULN; except subjects with Gilbert Syndrome who must have a total bilirubin level \< 3.0 ULN); AST (SGOT), ALT (SGPT) and alk phos \< 2.5 x ULN (\< 5 x ULN if liver metastases present)
Acceptable renal function: Creatinine \< 1.5 times ULN and creatinine clearance \> 60 ml/min using the Crockroft-Gault formula
Acceptable hematologic status: ANC \>1000 cells/μL; Platelet count \>100,000/μL; Hemoglobin \> 9.0 g/dL
INR and PT \< 1.5 ULN unless taking anti-coagulation, in which case PT, INR and aPTT must be within therapeutic range of intended use of anticoagulants
Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the Investigator's IRB/Ethics Committee
Willingness to comply with all study procedures and availability for the duration of the study
All women of childbearing potential must have a negative urine or serum pregnancy test within 72 hours of enrollment. If urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; all subjects must agree to use highly effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 5 months for women and 7 months for men after the last dose.

Exclusion

Currently receiving treatment with another investigational device or drug study, or \<14 days since ending treatment with another investigational device or drug study(s).
Subject has known sensitivity to trabectedin, gemcitabine or dacarbazine.
Female subject is pregnant or breast-feeding or planning to become pregnant during study treatment and through 3 months after the last dose of trabectedin, gemcitabine or dacarbazine.
Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of trabectedin, gemcitabine or dacarbazine.
Sexually active subjects and their partners unwilling to use male or female latex condom

What this trial measures

  • Progression free survival12 months

    Progression free survival up to disease progression or death from any cause