Ongoing Clinical Trials for Malignant Fibrous Histiocytoma
There are currently 3 clinical trials investigating new treatments for Malignant Fibrous Histiocytoma, also known as Undifferentiated Pleomorphic Sarcoma. These trials are taking place across several European countries including Denmark, Norway, Germany, Poland, Italy, France, and Spain. The studies focus on combination therapies using immunotherapy drugs and other targeted treatments, aiming to improve outcomes for patients with this rare and aggressive form of soft tissue sarcoma. (Also known as: Undifferentiated Pleomorphic Sarcoma, UPS)
Clinical trial locations
- Denmark
- France
- Germany
- Italy
- Norway
- Poland
- Spain
Study on Propranolol and Pembrolizumab for Patients with Advanced Angiosarcoma and Undifferentiated Pleomorphic Sarcoma
This trial is testing a combination treatment using propranolol hydrochloride, a heart medication also being studied for cancer effects, and pembrolizumab, an immunotherapy drug. The study focuses on patients with advanced forms of certain soft tissue sarcomas that have not responded to standard chemotherapy.
Who can participate: Adults aged 18 and older with confirmed advanced or spreading Undifferentiated Pleomorphic Sarcoma or Angiosarcoma that has not responded to standard chemotherapy. Participants must have measurable disease and be able to perform daily activities with an ECOG Performance Status score of 2 or less. They must have adequate organ function, including proper liver and kidney function, and acceptable blood counts. Women of childbearing potential and sexually active men must agree to use effective birth control during the study and for at least 120 days after treatment ends. A tumor tissue sample taken within 3 months before joining is required.
Who cannot participate: Patients with different types of cancer than those being studied, those unable to follow study procedures or attend required visits, people with serious health conditions that might interfere with the study, pregnant or breastfeeding women, and those participating in another clinical trial simultaneously. Also excluded are patients who have had recent surgery or treatment that might affect results, those with allergies to study medications, people with substance abuse history, and those unable to provide informed consent.
Treatment approach: The study evaluates how well the combination treatment controls cancer growth over three months. Propranolol hydrochloride is taken orally in tablet form, while pembrolizumab is administered through intravenous infusion directly into a vein. The treatment aims to determine the progression-free survival rate at 3 months, with regular clinic visits for monitoring and assessments including various tests to track the cancer’s response.
Investigational drugs: Propranolol is commonly used to treat high blood pressure and heart conditions, but researchers are interested in how it might help slow down or stop tumor growth. Pembrolizumab is an immunotherapy drug that works by blocking a specific protein on cancer cells, allowing the immune system to better recognize and attack these cells.
Study on the Effectiveness and Safety of INT230-6 (Vinblastine Sulfate, Cisplatin) for Adults with Metastatic Soft Tissue Sarcomas
This trial compares a new treatment called INT230-6 with standard care currently used for certain soft tissue sarcomas. The study specifically focuses on liposarcoma, undifferentiated pleomorphic sarcoma, and leiomyosarcoma. INT230-6 is a combination of vinblastine sulfate and cisplatin administered directly into the tumor.
Who can participate: Adults aged 18 and older of any sex who provide written consent. Participants must have confirmed diagnosis of soft tissue sarcoma including liposarcoma, leiomyosarcoma, or undifferentiated pleomorphic sarcoma that cannot be removed by surgery, is locally advanced, or has spread to other parts of the body. They 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. Participants must have measurable disease according to RECIST 1.1 criteria and at least one tumor suitable for injection that is at least 2 cm in size. They must have an ECOG performance status of 0, 1, or 2, and adequate organ function confirmed through blood tests. Women must not be pregnant or breastfeeding and must agree to use effective contraception during the study and for at least 7 months afterward. Male participants must also agree to use contraception and refrain from donating sperm during the study and for 6 months after.
Who cannot participate: Patients with other types of cancer not specified in the study, those who have had recent major surgery or procedures, people with severe heart problems, uncontrolled infections, pregnant or breastfeeding women, and those unable to follow study procedures. Also excluded are patients who participated in another clinical trial recently, those with a history of allergic reactions to study medications, people with severe liver or kidney disease, and those with a history of drug or alcohol abuse.
Treatment approach: Participants will be randomly assigned to receive either INT230-6 or standard care treatment. INT230-6 is injected directly into the tumor, while standard care may include medications such as eribulin given as an intravenous injection, trabectedin as an intravenous infusion, or pazopanib taken orally as a tablet. The study aims to compare overall survival of participants receiving INT230-6 with those receiving standard care, lasting up to 24 months with regular monitoring including 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, including a proprietary formulation called SHAO along with two chemotherapy drugs, vinblastine and cisplatin. The goal is to see if this treatment can help patients live longer compared to standard treatments by destroying cancer cells through disrupting their DNA and inhibiting cell division.
Study on Pembrolizumab and Olaparib for Patients with Resectable Soft Tissue Sarcoma
This trial explores the effects of pembrolizumab, administered through infusion, and possibly olaparib, taken as a tablet, in patients with Undifferentiated Pleomorphic Sarcoma and Dedifferentiated Liposarcoma. The treatment is given before standard surgery to remove the cancer, followed by additional pembrolizumab treatment after surgery.
Who can participate: Male or female patients aged 18 years or older who understand, sign, and date the consent form. Participants must have confirmed diagnosis of certain types of soft tissue sarcoma with the tumor removable by surgery at the time of joining, and no signs of cancer spread to other parts of the body on imaging tests. Patients with local return of cancer after surgery can join if they haven’t had chemotherapy or radiation before. The main tumor must be measurable by imaging tests and suitable for repeated assessments. Participants must have specific structures called Tertiary Lymphoid Structures identified in a tumor sample. They must have a performance status of 0 or 1, meaning they are fully active or have some restrictions but can carry out light work, and adequate blood and organ function as shown by lab tests. Female participants must not be pregnant or breastfeeding and must agree to use birth control during the study and for a certain period after the last dose of treatment. Male participants must also agree to use birth control and not donate sperm during this time. Participants must agree not to donate blood during the study and for 90 days after the last dose.
Treatment approach: Participants receive pembrolizumab and possibly olaparib during an initial treatment phase before surgery. Pembrolizumab is given as a solution for infusion directly into the bloodstream, while olaparib is taken orally in film-coated tablets. This “Window of Opportunity” treatment phase evaluates the potential effects of the medications on the tumor before the standard surgical procedure to remove it. Following surgery, an adjuvant treatment phase with pembrolizumab is conducted to support the immune response and help prevent tumor recurrence. Regular follow-up visits are scheduled to monitor health and disease status for up to two years post-surgery.
Investigational drugs: Pembrolizumab is an immunotherapy drug that works by blocking a protein called PD-1, helping the immune system better recognize and attack cancer cells. Olaparib is a PARP inhibitor that interferes with DNA repair in cancer cells, leading to their death. The study evaluates whether olaparib can improve the effectiveness of pembrolizumab in treating soft tissue sarcoma.
Summary
The three ongoing clinical trials for Malignant Fibrous Histiocytoma, also known as Undifferentiated Pleomorphic Sarcoma, represent diverse treatment approaches across multiple European countries. All three trials incorporate immunotherapy, specifically pembrolizumab, either alone or in combination with other agents, highlighting the current focus on harnessing the immune system to fight this aggressive cancer.
A notable observation is the geographic distribution of these trials, with France participating in two studies and the remaining trials spread across Scandinavia, Germany, Poland, Italy, and Spain. This broad geographic coverage may improve access for European patients seeking experimental treatment options.
The trials address different stages of disease: one focuses on advanced, metastatic cases that have not responded to standard chemotherapy, another targets metastatic soft tissue sarcomas comparing direct tumor injection therapy with standard care, and the third investigates treatment for resectable tumors before surgery. This range provides options for patients at various stages of their disease journey.
Two of the three trials explore combination therapies, pairing pembrolizumab with propranolol, olaparib, or direct tumor injection of chemotherapy agents. This reflects the growing understanding that combination approaches may offer better results than single-agent treatments for these challenging cancers.
