Uterine 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 trial is investigating treatment options for patients with soft tissue sarcoma, including uterine leiomyosarcoma, that has either spread to other parts of the body or has not responded to previous treatments. The study compares two approaches: using trabectedin alone or combining it with an experimental drug called tTF-NGR.

Main inclusion criteria: Patients must be between 18 and 75 years old with confirmed high-grade soft tissue sarcoma that did not respond to or cannot be treated with anthracycline medications. The tumor must test positive for a protein marker called CD13 with a score of 1 or higher. Patients need at least one measurable tumor that has not been previously treated with radiation and must have a life expectancy of at least 3 months. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 3 months afterward, while men must use contraception for 5 months after treatment.

Main exclusion criteria: Patients cannot participate if they are younger than 18 or older than 75, have not been treated with anthracycline therapy, test negative for CD13, are pregnant or breastfeeding, or have previously been treated with trabectedin. Those with severe heart, liver, or kidney problems, active uncontrolled infections, other active cancers requiring treatment, or known allergies to the study medications are also excluded.

Focus and goal: The trial aims to determine whether adding tTF-NGR to standard trabectedin treatment helps control cancer for a longer period. The experimental drug tTF-NGR is designed to help trap the chemotherapy medication inside the tumor, potentially making the treatment more effective. Participants will receive treatment for up to 360 days, with regular medical examinations and imaging tests to monitor how the cancer responds.

Investigational drugs: Trabectedin is a chemotherapy medication that interferes with cancer cell growth and division. It is typically used when other treatments, particularly anthracyclines, have not worked effectively. tTF-NGR is an experimental therapy designed to target blood vessels in tumors and help concentrate trabectedin where it is needed most. Both medications are administered through intravenous infusion directly into the bloodstream.

Study on Post-Operative Chemotherapy with Doxorubicin and Trabectedin for Patients with High-Risk Localized Uterine Leiomyosarcoma

This trial focuses specifically on uterine leiomyosarcoma that has been surgically removed but is considered high-risk for returning. The study is testing whether chemotherapy given after surgery can help prevent the cancer from coming back.

Main inclusion criteria: Patients must be women between 18 and 75 years old with FIGO stage I uterine leiomyosarcoma that has been completely removed surgically. The diagnosis must be confirmed by a pathologist within 8 weeks after surgery, and the tumor must have a high-risk genetic marker called CINSARC signature. Patients need adequate blood, kidney, liver, and heart function. Specifically, they must have sufficient white blood cells, hemoglobin, and platelets, normal kidney and liver function tests, and proper heart function measurements. Patients must not have received previous chemotherapy for sarcoma and must have no measurable disease after surgery as shown by imaging tests.

Main exclusion criteria: The trial is only open to women, so men cannot participate. Patients who have not had surgery to remove the tumor, those with a different cancer stage than FIGO stage I, or those who are not considered high risk according to the CINSARC test cannot join. Vulnerable populations unable to give informed consent are also excluded.

Focus and goal: The purpose of the study is to see if adding chemotherapy after surgery can help prevent cancer recurrence compared to observation alone. Participants will be randomly assigned to either receive chemotherapy or be observed without additional treatment. Those in the treatment group will receive up to four cycles of chemotherapy. The study will monitor participants for cancer recurrence, side effects, overall health, and quality of life. The trial is expected to conclude by September 2030.

Investigational drugs: The chemotherapy combination includes doxorubicin and trabectedin, both administered through intravenous infusion. Doxorubicin works by slowing or stopping the growth of cancer cells and is well-established for treating various cancers. Trabectedin interferes with cancer cell DNA, which can lead to cell death and potentially reduce the risk of cancer returning after surgery. Together, these medications aim to enhance treatment effectiveness in preventing recurrence.

Summary

The two ongoing clinical trials for uterine leiomyosarcoma represent different approaches to managing this aggressive cancer. One trial, based in France, focuses on preventing cancer recurrence after surgery in early-stage, high-risk patients using a combination of doxorubicin and trabectedin. The other trial, conducted in Germany, addresses more advanced cases where the cancer has spread or failed to respond to initial treatment, comparing trabectedin alone to a combination with the experimental drug tTF-NGR.

Both trials feature trabectedin as a key medication, highlighting its importance in treating this rare cancer. The French study specifically targets women with localized disease, while the German trial includes both men and women with various types of soft tissue sarcoma, including uterine leiomyosarcoma. Patients interested in participating should discuss eligibility criteria with their healthcare providers, as each trial has specific requirements regarding cancer stage, previous treatments, and overall health status.