Ongoing Clinical Trials for Recurrent Synovial Sarcoma
This article provides information about ongoing clinical trials for patients with recurrent synovial sarcoma. Currently, there is 1 active clinical trial available, testing a combination of trabectedin and an experimental drug called tTF-NGR for patients whose cancer has not responded to previous treatments.
Clinical trial locations
Study of Trabectedin alone versus Trabectedin with tTF-NGR combination therapy in adults with metastatic or refractory soft tissue sarcoma who failed first-line treatment
This clinical trial is being conducted in Germany and focuses on patients with synovial sarcoma and other types of soft tissue sarcoma whose cancer has spread to other parts of the body or has not responded to previous treatments. The study compares two approaches: treatment with trabectedin alone versus a combination of trabectedin and an experimental drug called tTF-NGR.
Who can participate:
This trial is open to adults between 18 and 75 years of age who have been diagnosed with advanced or metastatic soft tissue sarcoma, including synovial sarcoma. To be eligible, you must have high-grade disease (grade 2-3) that either did not respond to previous treatment with anthracycline medications or you cannot take anthracyclines due to medical reasons. Your tumor must test positive for a protein marker called CD13 with a score of 1 or higher, and you must have at least one measurable tumor that has not been previously treated with radiation. You should have a life expectancy of at least 3 months and be able to carry out most daily activities with limited assistance.
Women who can become pregnant must have a negative pregnancy test and use effective birth control during the study and for 3 months afterward. Men participating in the trial must use birth control methods for 5 months after their last treatment.
Who cannot participate:
You cannot join this trial if you are younger than 18 or older than 75 years of age. The study excludes patients who have never received anthracycline therapy, those whose tumors test negative for CD13, and anyone who has previously been treated with trabectedin. Women who are currently pregnant or breastfeeding cannot participate. You will also be excluded if you have severe heart, liver, or kidney problems, active uncontrolled infections, or other active cancers requiring treatment. Patients with known allergic reactions to the study medications or those who are participating in another clinical trial within the past 30 days are not eligible.
What the trial involves:
The main goal of this study is to determine whether adding tTF-NGR to standard trabectedin treatment helps keep the cancer under control for a longer time. Participants will be randomly assigned to one of two treatment groups: one receiving trabectedin alone and another receiving both trabectedin and tTF-NGR. Both medications are given through an intravenous infusion directly into the bloodstream. Treatment can continue for up to 360 days, or until the cancer progresses or other stopping criteria are met.
During the trial, you will undergo regular medical examinations and imaging tests to monitor how the cancer responds to treatment. Women of childbearing potential will need monthly pregnancy tests throughout the study. After treatment completion, follow-up monitoring will continue according to the study schedule, with the trial expected to run until March 2029.
Investigational drugs:
Trabectedin is a cancer medication that works by interfering with cancer cell growth and division. It is typically used when other treatments, particularly those containing anthracyclines, have not worked effectively. The experimental drug tTF-NGR is designed to work together with trabectedin by targeting blood vessels in tumors. The idea is that tTF-NGR helps trap the chemotherapy medication inside the tumor, keeping it concentrated where it’s needed most and potentially making the treatment more effective.
Summary
Currently, there is one active clinical trial available for patients with recurrent synovial sarcoma, located in Germany. This trial is testing whether adding an experimental drug called tTF-NGR to standard trabectedin treatment improves outcomes for patients whose cancer has not responded to previous treatments. The study is specifically designed for patients whose tumors test positive for the CD13 protein marker and who have already been treated with anthracycline medications or cannot take them for medical reasons. The trial represents an opportunity for eligible patients to access a novel combination therapy approach that aims to concentrate chemotherapy medication more effectively within tumors.
