Myxofibrosarcoma Trials in Disease

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 designed for adults with soft tissue sarcoma, including myxofibrosarcoma, whose cancer has either spread to other parts of the body or has not responded to previous treatments. The study compares two treatment approaches to determine which 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 that has either not responded to previous anthracycline chemotherapy or where anthracyclines cannot be used for medical reasons
• The tumor must test positive for a specific protein marker called CD13
• 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 age: negative pregnancy test and willingness to use effective birth control during the study and for 3 months afterward
• For men: willingness to use 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 chemotherapy
• Negative test for CD13 protein marker
• Currently pregnant 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 of the trial:

The trial aims to determine whether adding an experimental drug called tTF-NGR to standard trabectedin chemotherapy helps control the cancer better than trabectedin alone. Participants are randomly assigned to one of two groups: one receiving trabectedin only, and another receiving the combination of trabectedin with tTF-NGR. Both medications are given through intravenous infusion directly into the bloodstream. The experimental drug tTF-NGR is designed to help concentrate the chemotherapy medication inside the tumor, potentially making the treatment more effective.

During the study, participants receive treatment for up to 360 days. Regular medical examinations and imaging tests are performed to monitor how the cancer responds to treatment. The study focuses specifically on patients whose tumors show CD13 positivity, which is determined through laboratory testing. This trial is expected to continue until March 2029.

Investigational drugs:

Trabectedin is a cancer medication used to treat soft tissue sarcoma. It works by interfering with cancer cell growth and division. This medication is typically used when other treatments, particularly those containing anthracyclines, have not worked effectively.

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

There is currently one clinical trial available for patients with myxofibrosarcoma and other soft tissue sarcomas. This trial is being conducted in Germany and represents an important research effort for patients whose cancer has progressed or not responded to initial treatments. The study focuses on a combination therapy approach using trabectedin, an established chemotherapy medication, together with tTF-NGR, an experimental drug designed to improve treatment effectiveness by concentrating the chemotherapy within the tumor.

The trial is particularly relevant for patients whose tumors test positive for the CD13 protein marker and who have previously received anthracycline-based chemotherapy. The study will help researchers understand whether this combination approach offers better disease control compared to trabectedin alone. Patients interested in participating should discuss eligibility requirements with their healthcare team, particularly regarding age requirements, previous treatment history, and overall health status.