Pleomorphic liposarcoma 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 trial is investigating whether combining trabectedin with an experimental drug called tTF-NGR provides better results than using trabectedin alone. The treatment is designed for patients whose cancer has spread to other parts of the body or has not responded to previous treatments.

Who can participate: Adults between 18 and 75 years old with advanced soft tissue sarcoma who have either not responded to previous anthracycline treatment or cannot take anthracycline medications. Participants must have high-grade pleomorphic liposarcoma and test positive for a specific protein marker called CD13. They need to have at least one measurable tumor that hasn't been treated with radiation, a life expectancy of at least 3 months, and be able to carry out most daily activities. Women of childbearing potential must use effective birth control during the study and for 3 months afterward, while men must use contraception for 5 months after treatment.

Who cannot participate: People younger than 18 or older than 75, those without confirmed soft tissue sarcoma, anyone who hasn't previously received anthracycline therapy, or those who test negative for CD13. Pregnant or breastfeeding women are excluded, as are patients with severe heart, liver, or kidney problems, active infections, or other active cancers. People who have previously been treated with trabectedin, have known allergies to the study medications, or have participated in another clinical trial within the past 30 days cannot join.

Main focus: The study aims to determine if adding tTF-NGR to standard trabectedin treatment helps keep the cancer under control for a longer time. The experimental drug tTF-NGR is designed to help concentrate the chemotherapy medication inside the tumor, potentially making the treatment more effective. Participants will receive treatment for up to 360 days and undergo regular medical examinations and imaging tests to monitor how the cancer responds.

Investigational drugs: Trabectedin is a cancer medication that interferes with cancer cell growth and division, typically used when anthracycline-based treatments haven't worked. tTF-NGR is an experimental protein therapy that targets blood vessels in tumors and is intended to help trap trabectedin inside the tumor, making the treatment more concentrated where it's needed most. Both medications are given through intravenous infusion directly into the bloodstream.

Study on the Effectiveness and Safety of INT230-6 (Vinblastine Sulfate, Cisplatin) for Adults with Metastatic Soft Tissue Sarcomas

This clinical trial studies a treatment called INT230-6, which is injected directly into tumors. The study compares this new approach with standard care treatments currently used in the United States for specific types of soft tissue sarcomas, including pleomorphic liposarcoma.

Who can participate: Adults aged 18 and older with a confirmed diagnosis of pleomorphic liposarcoma or other specified soft tissue sarcomas that cannot be removed by surgery, are locally advanced, or have spread to other parts of the body. Participants must have received at least one previous treatment for advanced disease and shown progression after treatments like anthracycline-based therapy, but should not have had more than two previous treatments. They need at least one tumor that is at least 2 cm in size and can be targeted for injection. Participants must have adequate organ function as determined by blood tests, and be able to carry out most daily activities. Women of childbearing potential must use effective contraception during the study and for at least 7 months afterward, while men must use contraception for 6 months after the study ends.

Who cannot participate: Patients with cancer types not specified in the study, those who have had recent major surgery, or people with severe heart problems or uncontrolled infections. Pregnant or breastfeeding women are excluded, as are patients unable to follow study procedures or those who have participated in another clinical trial recently. People with a history of allergic reactions to the study medication, severe liver or kidney disease, or a history of drug or alcohol abuse cannot join.

Main focus: The study aims to determine whether INT230-6, administered directly into tumors, can improve overall survival compared to standard care treatments. The trial will last up to 24 months, during which participants will be closely monitored for the treatment's effectiveness, side effects, and impact on quality of life. Participants will undergo regular imaging tests to measure tumor size and blood tests to check organ function.

Investigational drugs: INT230-6 is a combination therapy injected directly into tumors. It includes a proprietary formulation called SHAO along with two chemotherapy drugs: vinblastine and cisplatin. This combination works by disrupting cancer cell DNA and inhibiting cell division. Participants receiving standard care may be treated with medications such as eribulin (given as an intravenous injection), trabectedin (given as an intravenous infusion), or pazopanib (taken orally as a tablet).

Summary

Both ongoing clinical trials for pleomorphic liposarcoma focus on patients whose disease has advanced or spread to other parts of the body after previous treatments. The trials are concentrated primarily in European countries, with Germany participating in both studies and France, Italy, Poland, and Spain participating in the INT230-6 trial.

A notable feature of these trials is the investigation of combination therapies and innovative delivery methods. One trial explores whether adding tTF-NGR to standard trabectedin treatment improves outcomes by concentrating chemotherapy inside tumors. The other trial tests a completely different approach by injecting a combination of drugs directly into tumors rather than administering them systemically.

Both studies require participants to have received previous treatment with anthracycline-based therapies and to have measurable disease. The trials emphasize the importance of adequate organ function and the ability to carry out daily activities. These studies represent important efforts to find more effective treatments for this challenging disease, particularly for patients who have already undergone standard therapies.