Actively Recruiting
Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Soft Tissue Sarcoma
Led by Sarcoma Oncology Research Center, LLC · Updated on 2025-02-24
80
Participants Needed
1
Research Sites
394 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.
CONDITIONS
Official Title
Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Pathologically confirmed locally advanced, unresectable, or metastatic leiomyosarcoma
- Previously treated with measurable disease per RECIST v1.1
- ECOG performance status of 2 or less
- Life expectancy of at least 3 months
- Liver function with bilirubin less than 1.5 times upper limit of normal (ULN), except Gilbert Syndrome patients must have bilirubin less than 3.0 ULN
- AST, ALT, and alkaline phosphatase less than 2.5 times ULN, or less than 5 times ULN if liver metastases present
- Renal function with creatinine less than 1.5 times ULN and creatinine clearance over 60 ml/min
- Hematologic status with ANC over 1000 cells/µL, platelet count over 100,000/µL, and hemoglobin over 9.0 g/dL
- INR and PT less than 1.5 ULN unless taking anticoagulants, in which case coagulation tests must be within therapeutic range
- Ability to understand study purposes and risks and provide signed informed consent
- Willingness to comply with study procedures and be available for study duration
- Women of childbearing potential must have a negative pregnancy test within 72 hours before enrollment and agree to use effective contraception during and after the study
You will not qualify if you...
- Currently receiving or within 14 days of ending treatment with another investigational drug or device
- Known sensitivity to trabectedin, gemcitabine, or dacarbazine
- Pregnant, breastfeeding, or planning pregnancy during treatment and for 3 months after last dose
- Female of childbearing potential unwilling to use effective contraception during treatment and for 3 months after last dose
- Sexually active subjects and partners unwilling to use male or female latex condoms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sant P Chawla
Santa Monica, California, United States, 90403
Actively Recruiting
Research Team
S
Sant P Chawla, MD
CONTACT
V
Victoria Chua-Alcala, MD
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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