In short
There are currently 4 ongoing clinical trials investigating new treatments for leiomyosarcoma, a rare type of cancer that develops in smooth muscle tissue. These studies are taking place across multiple countries in Europe and are testing various chemotherapy combinations and targeted therapies to improve outcomes for patients with advanced or metastatic disease.
Clinical trial locations
- Cyprus
- Czechia
- Denmark
- France
- Germany
- 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
- Study on the Effect of Chemotherapy with Ifosfamide, Dacarbazine, and Epirubicin Hydrochloride Before Surgery for Patients with High-Risk Retroperitoneal Sarcoma
- Study on the Effectiveness and Safety of INT230-6 (Vinblastine Sulfate, Cisplatin) for Adults with Metastatic Soft Tissue Sarcomas
- Italy
- Study Comparing Trabectedin and Gemcitabine for Patients with Advanced or Metastatic Leiomyosarcoma After Chemotherapy
- Study on the Effect of Chemotherapy with Ifosfamide, Dacarbazine, and Epirubicin Hydrochloride Before Surgery for Patients with High-Risk Retroperitoneal Sarcoma
- Study on the Effectiveness and Safety of INT230-6 (Vinblastine Sulfate, Cisplatin) for Adults with Metastatic Soft Tissue Sarcomas
- Netherlands
- Poland
- Slovakia
- Spain
Study Comparing Trabectedin and Gemcitabine for Patients with Advanced or Metastatic Leiomyosarcoma After Chemotherapy
This trial is designed for patients with advanced or metastatic leiomyosarcoma who have already received anthracycline-based chemotherapy. The study compares two treatment options: trabectedin and gemcitabine, both given through intravenous infusion.
Who can participate: Eligible patients must be at least 18 years old with confirmed leiomyosarcoma that cannot be removed by surgery or has spread to other parts of the body. Participants must have received previous anthracycline-based chemotherapy and completed any cancer treatments at least 21 days before joining the study. Good blood counts, liver function, and kidney function are required, and patients must have an ECOG Performance Status of 2 or less. Women who can become pregnant must use effective birth control, and all participants must provide informed consent.
Who cannot participate: Patients who have not received anthracycline-based chemotherapy or have a different type of cancer are excluded. Those belonging to vulnerable populations or outside the specified age range also cannot join.
Study goals: The main focus is measuring the growth modulation index (GMI), which assesses how well the treatment controls cancer growth. A GMI greater than 1.33 indicates treatment effectiveness. Researchers will also monitor overall survival, progression-free survival, and treatment safety.
Investigational drugs: Trabectedin interferes with cancer cell DNA to prevent growth and spread. Gemcitabine blocks cancer cells from making DNA necessary for division. Both medications are being tested to determine which better controls disease progression in patients who have already undergone chemotherapy.
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 study examines whether adding an experimental drug called tTF-NGR to standard trabectedin treatment improves outcomes for patients with soft tissue sarcoma, including leiomyosarcoma. The trial compares trabectedin alone versus the combination therapy.
Who can participate: Patients aged 18 to 75 years with confirmed high-grade soft tissue sarcoma that either did not respond to anthracycline treatment or cannot take anthracyclines due to medical reasons. Eligible tumor types include leiomyosarcoma, liposarcoma, fibrosarcoma, rhabdomyosarcoma, angiosarcoma, synovial sarcoma, and undifferentiated sarcoma. Patients must test positive for CD13 (a specific protein marker) and have at least one measurable tumor. Life expectancy must be at least 3 months, and ECOG Performance Status must be 2 or less. Women who can become pregnant must use effective birth control.
Who cannot participate: Patients outside the 18-75 age range, those without confirmed soft tissue sarcoma, anyone who has not received anthracycline therapy, those with negative CD13 test results, pregnant or breastfeeding women, patients with severe heart, liver, or kidney problems, active infections, other active cancers, or known allergies to study medications are excluded.
Study goals: The primary aim is to determine whether adding tTF-NGR to trabectedin keeps cancer under control for longer periods. The experimental drug is designed to concentrate chemotherapy medication inside tumors, potentially making treatment more effective. Researchers will monitor tumor response through regular imaging tests and assess overall health status throughout the study.
Investigational drugs: Trabectedin is a cancer medication that interferes with cancer cell growth and division, typically used when anthracycline-based treatments have failed. tTF-NGR is an experimental protein that targets blood vessels in tumors, designed to trap trabectedin inside tumor tissue and increase its local concentration and effectiveness.
Study on the Effect of Chemotherapy with Ifosfamide, Dacarbazine, and Epirubicin Hydrochloride Before Surgery for Patients with High-Risk Retroperitoneal Sarcoma
This trial investigates whether giving chemotherapy before surgery improves outcomes for patients with high-risk retroperitoneal sarcoma, including leiomyosarcoma. The study compares two approaches: chemotherapy followed by surgery versus surgery alone.
Who can participate: Patients must be at least 18 years old with confirmed primary high-risk leiomyosarcoma or liposarcoma in the retroperitoneal space or infra-peritoneal spaces of the pelvis. The tumor must be surgically removable as determined by imaging tests and must be unifocal (located in one area). Adequate blood and organ function, WHO performance status of 2 or less, and ASA score less than 3 are required. Tumor tissue and blood samples must be collected for research. Women who can become pregnant must use highly effective birth control during the study and for at least 6 months after treatment.
Who cannot participate: Patients with cancer types other than leiomyosarcoma or liposarcoma in specified areas, those who have had previous treatments that might interfere with results, individuals with severe or uncontrolled medical conditions, pregnant or breastfeeding women, patients unable to follow study procedures, those with known allergies to study medications, and individuals currently participating in another clinical trial are excluded.
Study goals: The primary focus is determining whether chemotherapy given before surgery (neoadjuvant chemotherapy) improves disease-free survival compared to surgery alone. Researchers will assess how long patients remain free of cancer after treatment, overall survival rates, tumor response to chemotherapy, and any treatment-related side effects. Regular imaging tests will monitor tumor size and spread throughout the study.
Investigational drugs: Neoadjuvant chemotherapy using a combination of ifosfamide, dacarbazine, epirubicin hydrochloride, and doxorubicin hydrochloride is given intravenously before surgery. The goal is to shrink tumors, making them easier to remove and potentially improving surgical outcomes and long-term disease control.
Study on the Effectiveness and Safety of INT230-6 (Vinblastine Sulfate, Cisplatin) for Adults with Metastatic Soft Tissue Sarcomas
This trial tests a new treatment called INT230-6, which is injected directly into tumors, for patients with certain types of soft tissue sarcomas including leiomyosarcoma. The study compares INT230-6 with standard care treatments currently used in the United States.
Who can participate: Patients must be at least 18 years old with confirmed soft tissue sarcoma (liposarcoma, leiomyosarcoma, or undifferentiated pleomorphic sarcoma) that cannot be removed by surgery, is locally advanced, or has spread to other parts of the body. Participants must have received at least one previous treatment for advanced disease and shown disease progression after anthracycline-based therapy, but not more than two previous treatments. At least one tumor must be suitable for injection (at least 2 cm in size and measurable by CT or MRI). ECOG performance status of 0, 1, or 2 is required, along with adequate organ function. Female participants must use effective contraception during the study and for 7 months after, while male participants must use contraception for 6 months after the study ends.
Who cannot participate: Patients with unspecified cancer types, recent major surgery, severe heart problems, uncontrolled infections, pregnancy or breastfeeding status, inability to follow study procedures, recent participation in another clinical trial, history of allergic reactions to study medication, severe liver or kidney disease, or history of drug or alcohol abuse are excluded.
Study goals: The primary aim is comparing overall survival of patients receiving INT230-6 with those receiving standard care treatments (which may include Halaven, Trabectedin, or Pazopanib). Researchers will monitor participants' health and response to treatment over up to 24 months, assessing effectiveness, side effects, and overall quality of life.
Investigational drugs: INT230-6 is a combination therapy injected directly into tumors, containing SHAO (a proprietary formulation), vinblastine, and cisplatin. This approach aims to destroy cancer cells by disrupting their DNA and inhibiting cell division, with the goal of improving survival for patients with soft tissue sarcomas that cannot be surgically removed or have spread to other body parts.
Summary
The four ongoing clinical trials for leiomyosarcoma demonstrate a diverse research landscape focused on improving treatment options for patients with advanced or metastatic disease. Three of the four trials are investigating treatments for patients whose cancer has already progressed after initial therapies, reflecting the significant need for effective second-line and beyond treatment options.
A notable concentration of trials is evident in Western Europe, with Germany, Italy, France, and Spain hosting multiple studies. One trial is specifically focused on leiomyosarcoma only, while three others include leiomyosarcoma as part of broader soft tissue sarcoma research. Trabectedin appears in three trials, either as a standalone treatment or in combination with other agents, highlighting its importance in current treatment approaches.
The trials employ various treatment strategies, including comparing different chemotherapy agents, testing combination therapies, evaluating neoadjuvant chemotherapy before surgery, and investigating novel intratumoral injection methods. These studies aim to improve disease-free survival, overall survival, and quality of life for patients with this challenging cancer. Patients interested in participating should discuss eligibility criteria with their healthcare providers, as requirements vary between studies regarding prior treatments, disease stage, and specific tumor characteristics.
