Small intestine leiomyosarcoma 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 patients with leiomyosarcoma and other types of soft tissue sarcoma that has either spread to other parts of the body or has not responded to previous treatments. The study compares two treatment approaches to help determine which works better at controlling the cancer.

Main inclusion criteria:

• Age between 18 and 75 years
• Confirmed diagnosis of high-grade soft tissue sarcoma, including leiomyosarcoma
• Advanced or metastatic disease that either did not respond to previous treatment with anthracycline medications or where anthracyclines cannot be used due to 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 with minimal limitations
• For women who can become pregnant: negative pregnancy test and agreement to use effective birth control during the study and for 3 months after
• For men: agreement 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 result for CD13 protein marker
• 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 trial aims to determine whether adding an experimental drug called tTF-NGR to standard trabectedin chemotherapy helps keep the cancer under control for a longer time compared to using trabectedin alone. Participants are randomly assigned to one of two groups: one receiving only trabectedin, and another receiving both trabectedin and tTF-NGR. Both medications are given through intravenous infusion directly into the bloodstream.

The experimental drug tTF-NGR is specifically designed to help trap the chemotherapy medication inside the tumor, potentially making the treatment more effective by concentrating it where it is needed most. The study requires that tumors show a specific characteristic called CD13 positivity, which is determined through laboratory testing before enrollment.

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 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

Currently, there is one clinical trial available for patients with small intestine leiomyosarcoma, located in Germany. This trial is part of a broader study for various types of soft tissue sarcoma and focuses on patients whose disease has progressed or who did not respond to initial treatment with anthracycline-based therapy.

The trial evaluates whether combining an experimental drug called tTF-NGR with standard trabectedin chemotherapy provides better disease control than trabectedin alone. An important requirement for participation is that the tumor must test positive for the CD13 protein marker, which helps identify patients who may benefit most from this targeted treatment approach.

Patients interested in this trial should discuss with their healthcare provider whether they meet the eligibility criteria, particularly regarding previous treatments, CD13 status, and overall health condition. The study represents an opportunity to access a novel combination therapy that aims to improve outcomes for patients with advanced soft tissue sarcoma, including leiomyosarcoma of the small intestine.