Ongoing Clinical Trials for Testicular Leiomyosarcoma
There is currently 1 ongoing clinical trial for testicular leiomyosarcoma, a rare type of soft tissue sarcoma. This trial is investigating combination therapy for patients with advanced or metastatic disease who did not respond to previous treatments. The study is being conducted in Germany and compares standard chemotherapy with an experimental combination approach.
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 investigating treatment options for patients with soft tissue sarcoma that has spread to other parts of the body or has not responded to previous treatments. The study compares two approaches: using trabectedin alone versus combining trabectedin with an experimental drug called tTF-NGR.
Main inclusion criteria:
- Age between 18 and 75 years
- Confirmed high-grade soft tissue sarcoma, including leiomyosarcoma, that did not respond to previous anthracycline treatment or when anthracyclines cannot be used
- Tumor must test positive for CD13, a specific protein marker
- At least one measurable tumor that has not been previously treated with radiation
- Life expectancy of at least 3 months
- Ability to carry out daily activities (ECOG Performance Status of 2 or less)
- For women of childbearing potential: negative pregnancy test and use of effective birth control during the study and for 3 months after
- For men: use of birth control methods for 5 months after the last treatment
Main exclusion criteria:
- Age below 18 or above 75 years
- No previous treatment with anthracycline therapy
- Negative test result for CD13
- Current pregnancy or breastfeeding
- Previous treatment with trabectedin
- Severe heart, liver, or kidney problems
- Active uncontrolled infections
- Other active cancers requiring treatment
- Known allergic reactions to the study medications
Focus and goal: The main goal of this study is to determine whether adding tTF-NGR to trabectedin treatment helps control the cancer for a longer period compared to using trabectedin alone. The trial focuses on patients whose tumors have a specific characteristic called CD13 positivity, which is determined through laboratory testing. Participants will receive treatment for up to 360 days, with regular medical examinations and imaging tests to monitor how the cancer responds to treatment.
Investigational drugs: The study uses two medications. Trabectedin is a chemotherapy 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. tTF-NGR is an experimental drug designed to work together with trabectedin. It targets blood vessels in tumors and helps concentrate the chemotherapy medication inside the tumor, potentially making the treatment more effective. Both medications are administered through intravenous infusion directly into the bloodstream.
Summary
Currently, there is one clinical trial available for patients with testicular leiomyosarcoma, which is a type of soft tissue sarcoma. This trial is being conducted in Germany and offers an opportunity for patients whose cancer has spread or has not responded to standard first-line treatments. The study investigates whether combining an experimental drug with standard chemotherapy can improve outcomes compared to chemotherapy alone. Patients interested in participating must meet specific criteria, including having tumors that test positive for CD13 and a life expectancy of at least 3 months. The trial is expected to continue until March 2029.
