Ongoing Clinical Trials for Chondrosarcoma
Chondrosarcoma is a rare type of bone cancer that develops in cartilage cells. Currently, there are 5 clinical trials investigating new treatments for patients with different forms of this disease. These studies are testing various medications and treatment approaches, including targeted therapies and combination treatments, primarily for patients with advanced or metastatic chondrosarcoma that cannot be surgically removed.
Clinical trial locations
- Belgium
- Denmark
- Study of Combined Imaging with Hyperpolarized [1-13C]Pyruvate and Fludeoxyglucose (18F) for Cancer Detection in Patients with Breast Cancer, Neuroendocrine Tumors, Lymphomas, or Sarcomas
- Study of ivosidenib in adults with advanced or metastatic chondrosarcoma with IDH1 mutation who are untreated or have had one prior treatment
- France
- Germany
- Ireland
- Italy
- Study of ivosidenib in adults with advanced or metastatic chondrosarcoma with IDH1 mutation who are untreated or have had one prior treatment
- Study of INBRX-109 (ozekibart) compared to placebo in adults with unresectable or metastatic chondrosarcoma – a rare bone cancer
- Study on Trabectedin for Adults and Young Adults with Advanced Mesenchymal Chondrosarcoma
- Netherlands
- Spain
- Study of ivosidenib in adults with advanced or metastatic chondrosarcoma with IDH1 mutation who are untreated or have had one prior treatment
- Study of INBRX-109 (ozekibart) compared to placebo in adults with unresectable or metastatic chondrosarcoma – a rare bone cancer
- Study of Trabectedin and Low-Dose Radiation Therapy for Adults and Young Adults with Advanced or Metastatic Soft Tissue and Bone Sarcomas
Study of Combined Imaging with Hyperpolarized [1-13C]Pyruvate and Fludeoxyglucose (18F) for Cancer Detection in Patients with Breast Cancer, Neuroendocrine Tumors, Lymphomas, or Sarcomas
This trial is testing a new imaging method that combines two different scanning techniques to better understand how tumors use energy. The study is conducted in Denmark and includes patients with various types of cancer, including sarcomas.
Who can participate: Adults aged 18 and older with a confirmed diagnosis of breast cancer, neuroendocrine neoplasms, lymphoma, or sarcoma are eligible. The tumor must be at least 1.5 centimeters in size. Patients must be able to provide informed consent and should not belong to vulnerable population groups.
Who cannot participate: The trial excludes people under 18 or over 65 years old, those unable to lie still in the scanner for up to 60 minutes, people with claustrophobia, those with metal implants incompatible with MRI, pregnant or breastfeeding women, patients with severe kidney problems, known allergies to the imaging substances, those who received experimental drugs within 30 days before the study, people with uncontrolled medical conditions, those weighing more than 180 kg, and patients with blood glucose levels above 200 mg/dL.
What the study involves: The research focuses on testing whether two imaging methods can be performed simultaneously using a combined PET/MR scanner. Participants receive two injectable substances: hyperpolarized [1-13C]pyruvate and Fluor-18-FDG. The imaging helps doctors understand how tumors process different nutrients and may lead to improved detection and monitoring methods.
Investigational substances: The study uses two imaging agents: Hyperpolarized [1-13C]Pyruvate, which helps visualize how cancer cells process nutrients using magnetic resonance spectroscopy, and 18F-FDG, a radioactive form of glucose used in PET imaging that accumulates in cancer cells due to their high glucose consumption.
Study of ivosidenib in adults with advanced or metastatic chondrosarcoma with IDH1 mutation who are untreated or have had one prior treatment
This trial is testing the medication ivosidenib in patients with conventional chondrosarcoma that has spread or cannot be completely removed. The study is conducted across multiple European countries including Germany, Italy, Belgium, France, Netherlands, Spain, and Denmark, and runs from May 2024 to April 2031.
Who can participate: Adults aged 18 and older with confirmed conventional chondrosarcoma (Grades 1, 2, or 3 diagnosed within the last 3 years) that is locally advanced or metastatic are eligible. The tumor must have a specific IDH1 mutation (R132C/L/G/H/S variants) confirmed by testing. Patients must have at least one measurable tumor and show disease progression (either tumor growth on two scans within 6 months or disease return within 6 months after surgery). For Grade 1 and 2 tumors, patients should have received no previous treatment or only one treatment; Grade 3 allows up to two previous treatments. The tumor must not be suitable for complete surgical removal.
Who cannot participate: People under 18, those with untreated brain metastases, patients who had more than one systemic therapy (for Grades 1 and 2), pregnant or breastfeeding women, those with severe heart problems (uncontrolled high blood pressure, recent heart attack, unstable heart rhythm), severe liver or kidney problems, active uncontrolled infections, other cancers within the past 3 years (with specific exceptions), conditions making participation unsafe, or inability to swallow oral medications are excluded.
What the study involves: Participants are randomly assigned to receive either ivosidenib tablets or placebo tablets. Neither the patient nor doctor knows which treatment is being given. The medication is taken daily for up to 24 months. Regular assessments include imaging scans to monitor tumor response, quality of life questionnaires, and blood tests. The study measures how long patients live without cancer progression, overall survival, and quality of life.
Investigational drug: Ivosidenib is an oral medication that blocks a specific enzyme (mutated IDH1) in cancer cells. It is designed specifically for patients with locally advanced or metastatic conventional chondrosarcoma containing the IDH1 mutation, either as their first treatment or after one previous treatment.
Study on Trabectedin for Adults and Young Adults with Advanced Mesenchymal Chondrosarcoma
This trial is studying trabectedin, a cancer medication, for treating a rare type of chondrosarcoma called mesenchymal chondrosarcoma that is positive for a specific genetic marker (HEY1-NCOA2). The study is conducted in Italy and is expected to continue until 2027.
Who can participate: Patients must be at least 16 years old with a confirmed diagnosis of mesenchymal chondrosarcoma containing the HEY1-NCOA2 fusion marker. The disease must be locally advanced (not surgically removable or patient declined surgery) or metastatic with measurable or evaluable tumors. Evidence of disease progression within 6 months before joining is required. Patients must have been treated with at least one prior anthracycline-based chemotherapy (maximum of 3 treatment lines) and have an ECOG Performance Status of 2 or less. Adequate heart function (at least 50% measured by echocardiogram), no blood clots in the past 12 months, and proper bone marrow and organ function are required. Female patients of childbearing potential must have negative pregnancy tests, and both men and women must use effective birth control during and after the study.
Who cannot participate: People younger than 16, those without advanced rearranged mesenchymal chondrosarcoma, patients not previously treated with anthracycline-based chemotherapy, those without the HEY1-NCOA2 positive marker, patients who have not received one to three lines of prior medical treatment, and those without progressive disease according to standard medical criteria are excluded.
What the study involves: The research aims to determine how well trabectedin reduces tumor size in patients who have already received anthracycline-based chemotherapy. Participants receive trabectedin through intravenous infusion. Regular tumor evaluations using imaging scans measure changes in size, and patients complete quality of life and health status questionnaires. Blood samples are collected to measure drug levels. Safety monitoring throughout the study tracks any side effects or health changes.
Investigational drug: Trabectedin works by binding to DNA in cells, disrupting the cell cycle and leading to cancer cell death. It is administered intravenously and is being studied for its effectiveness in treating advanced mesenchymal chondrosarcoma with the HEY1-NCOA2 genetic marker in patients who have already undergone chemotherapy.
Study of Trabectedin and Low-Dose Radiation Therapy for Adults and Young Adults with Advanced or Metastatic Soft Tissue and Bone Sarcomas
This trial combines trabectedin medication with low-dose radiation therapy for patients with advanced or metastatic sarcomas, including bone tumors like osteosarcoma and chondrosarcoma. The study is conducted in Spain and is estimated to end by May 2025.
Who can participate: Patients aged 16 to 75 with a diagnosis of certain sarcomas (soft tissue sarcoma, bone tumors including osteosarcoma and chondrosarcoma, or small round-cell sarcomas) that are advanced or have spread and cannot be removed by surgery are eligible. The cancer must be in a location allowing safe radiation treatment, confirmed by a radiation doctor. Tumors chosen for radiation must cause significant symptoms. Patients must show disease progression in the last 6 months, be eligible for chemotherapy, and have had at least one but no more than three previous treatments (trabectedin must not have been used before). Patients must have measurable disease, adequate organ and bone marrow function, good respiratory function (if lung-related tumors), normal heart function (LVEF 50% or more), and a performance status of 1 or less. Both men and women who can have children must use effective birth control during the study and for 6 months after. Women must have a negative pregnancy test. A central venous catheter is required, and written informed consent must be provided.
Who cannot participate: Patients without the specified sarcoma types (advanced or metastatic soft tissue sarcoma, bone tumors like osteosarcoma or chondrosarcoma, or small round-cell sarcomas), those without measurable disease, people who are not adults or young adults, and patients who are part of vulnerable populations are excluded.
What the study involves: The treatment combines trabectedin (given through intravenous infusion at 1.5 milligrams per square meter of body surface) with low-dose radiation therapy applied to specific tumor sites. The radiation dose is 45 Gy for tumors in the arms or legs and 30 Gy for tumors in other areas. A central venous catheter is necessary for medication administration. Treatment is given in cycles, with pain and quality of life assessed regularly. The study monitors tumor response in irradiated areas, progression-free survival, overall survival, and safety throughout the treatment period.
Investigational treatments: Trabectedin interferes with cancer cell growth by binding to DNA and disrupting the cell cycle, slowing cancer spread. Low-dose radiation therapy uses high-energy rays to target and destroy cancer cells, combined with trabectedin to enhance treatment effectiveness while minimizing damage to healthy surrounding tissues.
Study of INBRX-109 (ozekibart) compared to placebo in adults with unresectable or metastatic chondrosarcoma – a rare bone cancer
This study tests INBRX-109 (also known as ozekibart) in patients with conventional chondrosarcoma that cannot be surgically removed or has spread to other parts of the body. The trial is conducted across multiple European countries including France, Netherlands, Germany, Spain, Italy, and Ireland, and continues until June 2025.
Who can participate: Adults aged 18 to 85 (both men and women) with conventional chondrosarcoma that is either unresectable or metastatic are eligible. Patients must provide stored tumor tissue samples or agree to a fresh biopsy. Tumors must be measurable using RECIST criteria, and disease progression must be shown on scans within 6 months before starting treatment. Adequate blood cell counts, blood clotting function, liver and kidney function are required. Good physical functioning (ECOG score of 0 or 1, with exceptions for patients with limited mobility from previous cancer surgery) and a life expectancy of at least 12 weeks are necessary.
Who cannot participate: Prior treatment with death receptor 5 (DR5) targeted therapy, history of central nervous system metastases (unless treated and stable for at least 4 weeks), active autoimmune disease requiring systemic treatment, known HIV infection or hepatitis B or active hepatitis C, major surgery within 4 weeks before starting, history of other cancers within the past 3 years (except successfully treated non-melanoma skin cancer or cervical cancer in situ), serious heart conditions (uncontrolled high blood pressure or recent heart attack), severe liver dysfunction, pregnant or breastfeeding women, known allergies to the study medication, participation in another clinical trial within 4 weeks, or any condition interfering with safe study conduct are exclusions.
What the study involves: Participants are randomly assigned to receive either INBRX-109 or placebo through intravenous infusion, with additional medications (glucose solution, acetylcysteine, dexamethasone, diphenhydramine) possibly given to manage potential side effects. Treatment continues for up to 150 days. Regular monitoring includes imaging tests to check cancer response, blood tests, quality of life questionnaires focusing on pain and physical function, and tracking of any side effects. The study measures how long patients live without cancer progression and overall survival.
Investigational drug: INBRX-109 is an experimental medication designed to target and fight cancer cells in chondrosarcoma that has spread or cannot be surgically removed. It is being compared to placebo to determine its effectiveness at slowing or stopping disease progression.
Summary
The five clinical trials for chondrosarcoma represent diverse approaches to treating this rare bone cancer. The studies are geographically concentrated in Western Europe, with Germany, Italy, France, Spain, and the Netherlands hosting multiple trials. Denmark, Belgium, and Ireland also participate in the research efforts.
Several trials focus specifically on advanced or metastatic conventional chondrosarcoma, the most common form of the disease. Two studies test targeted therapies: ivosidenib for tumors with IDH1 mutations, and INBRX-109 (ozekibart) for conventional chondrosarcoma. Both are randomized, placebo-controlled trials designed to measure progression-free survival and overall survival.
Trabectedin appears in two separate studies: one as a single agent for mesenchymal chondrosarcoma with HEY1-NCOA2 fusion, and another combining it with low-dose radiation therapy for various sarcomas including chondrosarcoma. These trials focus on patients who have already received previous treatments, particularly anthracycline-based chemotherapy.
One trial takes a different approach by studying imaging techniques rather than treatment, using combined PET and MR spectroscopy to better understand tumor metabolism in various cancers including sarcomas.
Most trials require patients to have measurable disease and evidence of recent progression. Age requirements vary, with most accepting adults 18 and older, though two studies include young adults starting at age 16. Common exclusions include pregnancy, severe organ dysfunction, recent other cancers, and inability to tolerate the study procedures.
