Ongoing Clinical Trials for Dedifferentiated Liposarcoma
There are currently 7 clinical trials studying new treatments for dedifferentiated liposarcoma, a rare cancer that develops in fat cells. These trials are testing various medications and treatment combinations in multiple European countries, aiming to find more effective options for patients with this challenging disease.
Clinical trial locations
- Belgium
- Cyprus
- Czechia
- Denmark
- Finland
- France
- 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
- Study Comparing BI 907828 and Doxorubicin for Patients with Advanced Dedifferentiated Liposarcoma
- Study on Pembrolizumab and Olaparib for Patients with Resectable Soft Tissue Sarcoma
- 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
- Study Comparing BI 907828 and Doxorubicin for Patients with Advanced Dedifferentiated Liposarcoma
- Greece
- Italy
- 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
- Study Comparing BI 907828 and Doxorubicin for Patients with Advanced Dedifferentiated Liposarcoma
- Study on the Safety and Tolerance of BI 907828 in Patients with Advanced Dedifferentiated Liposarcoma
- Netherlands
- Norway
- Poland
- Portugal
- Slovakia
- Spain
- 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
- Study Comparing BI 907828 and Doxorubicin for Patients with Advanced Dedifferentiated Liposarcoma
- Sweden
Study of Pemigatinib and Retifanlimab for Patients with Advanced Dedifferentiated Liposarcoma
This trial is testing a combination of two medications, pemigatinib and retifanlimab, for patients with advanced disease. The main goal is to evaluate how long patients can live without their cancer getting worse and to assess overall survival.
Main inclusion criteria: Patients must be 18 years or older with a confirmed diagnosis showing positive MDM2 test results. They must have at least one measurable tumor that cannot be removed by surgery and be willing to provide tissue samples through biopsy. Participants should have a performance status of 0-2 on the ECOG scale, meaning they can carry out most daily activities.
Main exclusion criteria: Patients with a different type of cancer, those outside the specified age range, or those unable to understand study procedures cannot participate. Pregnant or breastfeeding women, patients with serious health conditions that might interfere, those with recent participation in other clinical trials, and those with allergies to the study medications are also excluded.
Focus: The study monitors progression-free survival at 24 weeks and evaluates the response to treatment. Pemigatinib is taken as a tablet, while retifanlimab is given through an intravenous infusion. The trial also assesses any side effects and changes in quality of life throughout the treatment period.
Investigational drugs: Pemigatinib targets specific pathways in cancer cells to slow disease progression. Retifanlimab helps the immune system recognize and attack cancer cells by blocking certain proteins.
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 compares two approaches for treating soft tissue sarcoma: trabectedin alone versus trabectedin combined with tTF-NGR. The study focuses on patients whose cancer has spread or did not respond well to previous treatments.
Main inclusion criteria: Patients must be between 18 and 75 years old with advanced or metastatic soft-tissue sarcoma that did not respond to previous anthracycline treatment or where anthracyclines cannot be used. They must have confirmed high-grade soft tissue sarcoma, test positive for CD13 protein marker, and have at least one measurable tumor. Life expectancy must be at least 3 months with an ECOG Performance Status of 2 or less.
Main exclusion criteria: Patients below 18 or above 75 years, without confirmed soft-tissue sarcoma diagnosis, or without previous anthracycline therapy cannot participate. Those who are pregnant, breastfeeding, have severe heart, liver, or kidney problems, active infections, or other active cancers requiring treatment are excluded. Previous treatment with trabectedin also disqualifies participation.
Focus: The trial determines whether adding tTF-NGR to trabectedin helps control cancer for longer. Both medications are given through intravenous infusion, with treatment continuing for up to 360 days. Regular examinations and imaging tests monitor treatment response.
Investigational drugs: Trabectedin is a chemotherapy medication that interferes with cancer cell growth. tTF-NGR is designed to help concentrate trabectedin inside the tumor, potentially making treatment more effective.
Study on the Effect of Chemotherapy with Ifosfamide, Dacarbazine, and Epirubicin Hydrochloride Before Surgery for Patients with High-Risk Retroperitoneal Sarcoma
This trial examines whether giving chemotherapy before surgery improves outcomes for patients with retroperitoneal sarcoma, specifically leiomyosarcoma and liposarcoma subtypes.
Main inclusion criteria: Patients must be at least 18 years old with confirmed primary high-risk leiomyosarcoma or liposarcoma in the retroperitoneal or infra-peritoneal pelvic spaces. They must have a WHO performance status of 2 or less, adequate blood and organ function, and an ASA score less than 3. The tumor must be resectable and measurable by imaging tests. Tissue and blood samples must be provided for research. Women of childbearing potential must have negative pregnancy tests and use effective birth control.
Main exclusion criteria: Patients with cancer types other than leiomyosarcoma or liposarcoma in specified areas, those with previous treatments that might interfere with results, severe or uncontrolled medical conditions, pregnant or breastfeeding women, and those unable to follow study procedures are excluded.
Focus: Patients are randomly assigned to receive either chemotherapy followed by surgery or surgery alone. The chemotherapy includes ifosfamide, dacarbazine, epirubicin hydrochloride, and doxorubicin hydrochloride given intravenously. The study monitors disease-free survival, overall survival, response to chemotherapy, and side effects.
Investigational drugs: Neoadjuvant chemotherapy is given before surgery to shrink tumors, making them easier to remove and potentially improving long-term outcomes.
Study on the Effectiveness and Safety of INT230-6 (Vinblastine Sulfate, Cisplatin) for Adults with Metastatic Soft Tissue Sarcomas
This trial studies a new treatment called INT230-6 for specific types of soft tissue sarcomas including liposarcoma, undifferentiated pleomorphic sarcoma, and leiomyosarcoma. It compares this new treatment with standard care currently used.
Main inclusion criteria: Participants must be at least 18 years old with confirmed diagnosis of specific soft tissue sarcoma types. They must have received at least one previous treatment that showed disease progression but no more than two previous treatments. At least one tumor must be suitable for injection and measurable by CT or MRI scans. ECOG performance status must be 0, 1, or 2, and adequate organ function is required.
Main exclusion criteria: Patients with other cancer types not specified, those who had recent major surgery, severe heart problems, uncontrolled infections, pregnant or breastfeeding women, and those unable to follow study procedures are excluded. Recent participation in other clinical trials, allergic reactions to study medication, severe liver or kidney disease, and history of drug or alcohol abuse also prevent participation.
Focus: INT230-6 is administered directly into the tumor, combining vinblastine sulfate and cisplatin. Standard care participants may receive Halaven, Trabectedin, or Pazopanib. The study lasts up to 24 months with close monitoring of health and treatment response.
Investigational drugs: INT230-6 is a combination therapy injected into tumors, including SHAO, vinblastine, and cisplatin, designed to improve overall survival compared to standard treatments.
Study Comparing BI 907828 and Doxorubicin for Patients with Advanced Dedifferentiated Liposarcoma
This trial compares a new treatment called brigimadlin with the chemotherapy drug doxorubicin as first-line treatment for advanced disease.
Main inclusion criteria: Patients must be at least 18 years old with confirmed advanced disease that cannot be removed by surgery and is worsening or recurring. A written pathology report showing positive MDM2 test results is required. At least one measurable tumor must be present. ECOG performance status must be 0 or 1, and patients must be willing to provide blood samples for analysis.
Main exclusion criteria: Patients with different cancer types, those who received previous treatment with drugs similar to doxorubicin, those outside the specified age range, or unable to provide informed consent cannot participate. Serious health conditions that might interfere, pregnancy or breastfeeding, and current participation in another clinical trial also exclude participation.
Focus: Participants are randomly assigned to receive either brigimadlin tablets or doxorubicin infusion. The study monitors disease progression and overall survival, with brigimadlin treatment lasting up to 21 days and doxorubicin up to 126 days. Regular assessments track treatment response and side effects.
Investigational drugs: Brigimadlin targets specific cancer cell pathways to slow or stop growth. Doxorubicin is an established chemotherapy drug that interferes with cancer cell growth and spread.
Study on Pembrolizumab and Olaparib for Patients with Resectable Soft Tissue Sarcoma
This trial explores the effects of pembrolizumab, possibly combined with olaparib, for patients with undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma that can be surgically removed.
Main inclusion criteria: Patients must be at least 18 years old with confirmed diagnosis of specific soft tissue sarcoma types. The tumor must be removable by surgery without need for pre-surgery chemotherapy. No cancer spread to other body parts should be visible on imaging. Specific structures called Tertiary Lymphoid Structures must be present in tumor samples. Performance status must be 0 or 1, and adequate blood and organ function is required.
Main exclusion criteria: The trial excludes patients with other cancer types not specified in the study, those unable to understand or follow procedures, pregnant or breastfeeding women, and those with serious health conditions that might interfere with the study.
Focus: Patients receive pembrolizumab with or without olaparib before surgery in a “Window of Opportunity” period. After surgery, pembrolizumab treatment continues. The study evaluates immune response enhancement and monitors cancer response and tumor changes.
Investigational drugs: Pembrolizumab blocks specific proteins on cancer cells, helping the immune system attack them. Olaparib interferes with DNA repair in cancer cells, potentially improving pembrolizumab’s effectiveness.
Study on the Safety and Tolerance of BI 907828 in Patients with Advanced Dedifferentiated Liposarcoma
This trial evaluates the safety of brigimadlin in patients with advanced or metastatic disease by monitoring side effects during treatment.
Main inclusion criteria: Patients must be at least 18 years old with confirmed diagnosis that is advanced or has spread. A pathology report showing positive MDM2 test results is required. At least one measurable tumor must be present. ECOG performance status must be 0 or 1, with life expectancy of at least 3 months. The study includes both treatment-naive and previously treated patients.
Main exclusion criteria: Patients with different cancer types, those outside the specified age range, unable to follow study procedures, pregnant or breastfeeding women, and those with serious health conditions or taking interfering medications are excluded.
Focus: The study monitors the occurrence, severity, and frequency of side effects from brigimadlin tablets taken orally. It also observes how the cancer responds, including whether it shrinks or stops growing. Treatment continues for several months to gather comprehensive safety data.
Investigational drugs: Brigimadlin targets specific pathways involved in cancer cell growth and survival, with ongoing research to understand its full potential and safety profile.
Summary
The 7 ongoing clinical trials for dedifferentiated liposarcoma are taking place across multiple European countries, with particularly strong representation in Germany, France, Italy, and Spain. These trials test various treatment approaches including targeted therapies, immunotherapy combinations, and chemotherapy regimens.
Several trials focus on brigimadlin, a newer investigational medication, comparing it to standard treatments or evaluating its safety profile. Other approaches include combining immunotherapy with PARP inhibitors, using chemotherapy before surgery, and testing intratumoral injection therapies. Most trials require patients to have confirmed MDM2-positive disease and adequate performance status.
These studies reflect the ongoing effort to find more effective treatments for this challenging cancer type, with trials exploring both first-line treatments for newly diagnosed patients and options for those who have already undergone previous therapies. The geographic distribution allows access to experimental treatments across much of Europe.
