Ongoing Clinical Trials for Recurrent Leiomyosarcoma
There is currently 1 clinical trial ongoing for patients with recurrent leiomyosarcoma. This trial is taking place in Germany and is testing a combination treatment approach that may help patients whose cancer has returned or has not responded to previous therapies.
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 studies treatment options for patients with soft tissue sarcoma, including leiomyosarcoma, whose cancer has spread to other parts of the body or has not responded well to previous treatments. The study compares two different treatment approaches to determine which one is more effective at keeping the cancer under control.
Main inclusion criteria:
- Adults between 18 and 75 years of age
- Confirmed diagnosis of high-grade soft tissue sarcoma (grade 2-3), including leiomyosarcoma and several other types such as liposarcoma, fibrosarcoma, rhabdomyosarcoma, angiosarcoma, synovial sarcoma, or undifferentiated sarcoma
- Advanced or metastatic disease that either did not respond to previous treatment with anthracycline medications or patients who cannot take anthracycline medications for medical reasons
- Tumor must test positive for CD13, a specific protein marker, with a score of 1 or higher
- 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)
- Women of childbearing potential must have a negative pregnancy test and use effective birth control during the study and for 3 months afterward; men must use birth control methods for 5 months after the last treatment
Main exclusion criteria:
- Age below 18 or above 75 years
- No confirmed diagnosis of soft-tissue sarcoma
- 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
- Participation in another clinical trial within the past 30 days
Focus and goal of the trial:
The study aims to determine whether adding an experimental drug called tTF-NGR to standard trabectedin treatment helps keep the cancer under control for a longer time compared to using trabectedin alone. Participants are randomly assigned to one of two treatment groups: some receive only trabectedin (a chemotherapy medication), while others receive both trabectedin and tTF-NGR. Both medications are given through an intravenous infusion directly into the bloodstream. The experimental drug tTF-NGR is designed to help trap the chemotherapy medication inside the tumor, potentially making the treatment more effective. Treatment can continue for up to 360 days, and participants undergo regular medical examinations and imaging tests to monitor how the cancer responds to treatment. The study is expected to continue until March 2029.
Investigational drugs being tested:
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. In this trial, it serves as the standard treatment option.
tTF-NGR is an experimental therapy designed to work together with trabectedin. It is a protein that targets blood vessels in tumors and is intended to help trap the cancer medication inside the tumor. This combination approach aims to make the cancer treatment more effective by keeping the medication concentrated where it is needed most.
Summary
Currently, there is one active clinical trial available for patients with recurrent leiomyosarcoma, taking place in Germany. This trial focuses on evaluating whether combining an experimental drug called tTF-NGR with standard trabectedin chemotherapy can improve outcomes compared to trabectedin alone. The study is specifically designed for patients whose cancer has spread or returned after initial treatment with anthracycline-based therapies, and whose tumors test positive for a protein marker called CD13. Patients interested in this trial should discuss with their healthcare provider whether they meet the eligibility criteria and whether participation might be appropriate for their individual situation.
