Ongoing Clinical Trials for Osteosarcoma
There are currently 6 clinical trials investigating new treatments for osteosarcoma, a type of bone cancer that primarily affects children, adolescents, and young adults. These trials are being conducted across several European countries and are testing various approaches including immunotherapy, chemotherapy combinations, and bone-strengthening medications.
Clinical trial locations
- Czechia
- Denmark
- France
- Germany
- Long-term safety study of GD2IL18CART treatment in patients with neuroblastoma, osteosarcoma, Ewing sarcoma, or advanced breast cancer
- Study of Cobolimab and Dostarlimab for Children and Young Adults with Newly Diagnosed or Relapsed/Refractory Tumors
- Study on the Safety and Dosage of GD2IL18CART for Patients with Relapsed or Refractory GD2 Positive Solid Cancers
- Italy
- Spain
Long-term safety study of GD2IL18CART treatment in patients with neuroblastoma, osteosarcoma, Ewing sarcoma, or advanced breast cancer
This trial focuses on monitoring patients who have previously received GD2IL18CART, a specialized type of cell therapy. The study aims to understand the long-term safety of this treatment by tracking patients over an extended period until May 2041.
Main inclusion criteria: Patients must have previously received GD2IL18CART treatment in the main clinical trial and be aged between 2 and 64 years. They need to provide informed consent and be willing to participate in long-term safety monitoring. The trial includes patients with neuroblastoma, osteosarcoma, Ewing sarcoma, or advanced breast cancer.
Main exclusion criteria: The study excludes pregnant women and breastfeeding mothers, people with active autoimmune diseases or uncontrolled infections, patients with severe heart, liver, or kidney problems, and those with uncontrolled brain metastases. Patients who received other experimental treatments within the last 30 days or have inadequate bone marrow function cannot participate.
Focus and goal: The trial monitors delayed side effects, disease progression, and overall health status through regular check-ups. For younger patients, growth and development are also monitored. The research team collects information about patients’ overall health and performs tests to check if the treatment cells are still present in their bodies.
Investigational drug: GD2IL18CART is a type of cell therapy where a patient’s own immune cells (T cells) are modified in a laboratory to target a specific protein called GD2 found on cancer cells. The modified cells also contain a component called IL18 which helps boost the immune response.
Study on Mifamurtide with Chemotherapy for Patients with High-Risk Osteosarcoma
This trial evaluates whether adding mifamurtide (MEPACT) to standard chemotherapy can improve outcomes for patients with high-risk osteosarcoma, which includes cases where the cancer has spread at diagnosis or has shown poor response to initial treatment.
Main inclusion criteria: Patients must be between 2 and 50 years old with newly diagnosed high-grade osteosarcoma confirmed by biopsy. They must have normal blood, kidney, heart, and liver functions, have received pre-operative chemotherapy, and undergone surgery to remove the primary tumor. Women who can have children must have a negative pregnancy test before joining the study.
Main exclusion criteria: Patients outside the age range of 2 to 50 years cannot participate. Those who do not have high-risk osteosarcoma, have not had surgery to remove the main tumor and any lung tumors, or have not received chemotherapy before surgery are excluded. Patients unable to receive additional treatment after surgery or unable to follow study procedures are also excluded.
Focus and goal: The study randomly assigns patients to receive either standard chemotherapy alone or chemotherapy combined with mifamurtide. Treatment is administered over several weeks, with the goal of evaluating event-free survival, which measures the time until cancer progression, relapse, or other significant events. The trial also assesses overall survival, progression-free survival, and the safety of the treatment.
Investigational drug: Mifamurtide is given intravenously as an add-on treatment to standard chemotherapy, which includes doxorubicin hydrochloride, ifosfamide, cisplatin, methotrexate, and etoposide. It works by stimulating the immune system to attack cancer cells, enhancing the body’s natural defense mechanisms.
Study on the Safety and Dosage of GD2IL18CART for Patients with Relapsed or Refractory GD2 Positive Solid Cancers
This trial tests GD2IL18CART treatment for patients with cancers that have returned or are not responding to standard treatments, including neuroblastoma, Ewing sarcoma, osteosarcoma, and advanced breast cancer. The therapy uses modified immune cells to target cancer cells more effectively.
Main inclusion criteria: Patients must have relapsed or refractory neuroblastoma, Ewing sarcoma, osteosarcoma, or advanced breast cancer that cannot be cured with standard treatments. For osteosarcoma, patients must have received initial therapy and at least one prior chemotherapy treatment for relapse, with certain types of relapse requiring disease that cannot be surgically removed. GD2 expression must be present on tumor cells, and patients must be between 1 and 79 years old with adequate T cell counts and performance scores.
Main exclusion criteria: The study excludes patients with a history of severe allergic reactions to similar treatments, those who are pregnant or breastfeeding, patients with uncontrolled infections, and those who received another experimental treatment within the last 30 days. Individuals with certain heart problems, active autoimmune diseases, or a history of substance abuse are also excluded.
Focus and goal: The study aims to determine the safety and appropriate dosage of GD2IL18CART. Participants receive the treatment through intravenous infusion, with regular monitoring for side effects and cancer response. At week 12, the response is evaluated by assessing complete or partial remissions, and patients are followed for a year to monitor long-term effects and overall survival.
Investigational drug: GD2IL18CART involves modifying a patient’s own immune cells to recognize and attack cancer cells that have a specific marker called GD2. The therapy is designed to enhance the immune system’s ability to fight cancer.
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 to treat advanced or metastatic sarcomas, including bone tumors such as osteosarcoma and chondrosarcoma. The study focuses on how well tumors respond to this combination treatment.
Main inclusion criteria: Patients must have a diagnosis of advanced or metastatic sarcoma that cannot be removed by surgery, including osteosarcoma and chondrosarcoma. They must be between 16 and 75 years old with a performance status of 1 or less, indicating ability to carry out light activities. Patients need adequate bone marrow, respiratory, and organ function with normal blood test results. They must have measurable disease and have had at least one but no more than three previous treatments for advanced cancer.
Main exclusion criteria: Patients without a diagnosis of eligible sarcoma types or without measurable disease cannot participate. Those who have not had prior treatment as required or are not within the specified age range are excluded.
Focus and goal: The study monitors how tumors respond to the combination of trabectedin and low-dose radiation, particularly in areas that receive radiation therapy. Researchers track changes in tumor size, treatment effectiveness over time, and effects on pain levels and overall well-being. The overall response rate, progression-free survival, and overall survival are key measures being evaluated.
Investigational drugs: Trabectedin is administered intravenously at a dose of 1.5 milligrams per square meter of body surface. It works by interfering with cancer cell growth. Low-dose radiation therapy uses high-energy rays to target and destroy cancer cells, with doses varying by location (45 Gy for extremities and 30 Gy for non-extremity areas).
Study of Cobolimab and Dostarlimab for Children and Young Adults with Newly Diagnosed or Relapsed/Refractory Tumors
This trial studies the combination of cobolimab and dostarlimab in children and young adults with tumors that have returned after treatment or have not responded to previous treatments. The study is conducted in two parts to assess safety, determine appropriate dosage, and evaluate effectiveness.
Main inclusion criteria: Participants must be within specific age ranges (from newborn to under 21 years, depending on the study cohort) and have advanced or metastatic solid tumors that have worsened after available treatments. Patients must have at least one measurable tumor lesion and adequate performance status (60% or higher on the Karnofsky or Lansky scale). They need adequate organ function with specific blood test requirements, and adolescents must agree to use contraception during the study.
Main exclusion criteria: The study excludes patients who have not recovered from previous treatments, those with other serious uncontrolled illnesses, pregnant or breastfeeding women, and patients who have had another cancer within the last 5 years. Those who have had an organ transplant, have known allergies to the study drugs, active infections requiring treatment, or a history of autoimmune diseases cannot participate.
Focus and goal: The study aims to understand the safety and tolerability of cobolimab and dostarlimab when used together, determine the best dose, and explore how these medications work in the body and their ability to fight tumors. The trial monitors participants closely for side effects and changes in health throughout the treatment period.
Investigational drugs: Cobolimab and dostarlimab are both immunotherapy agents administered through intravenous infusion. They work by helping the immune system recognize and attack cancer cells. Cobolimab targets specific proteins that activate the immune response, while dostarlimab blocks proteins that cancer cells use to evade the immune system.
Study on Zoledronic Acid for Treating Osteosarcoma in Children, Adolescents, and Adults
This trial investigates whether adding zoledronic acid to standard treatment can improve outcomes for patients with high-grade osteosarcoma. The study compares patients receiving standard treatment alone with those receiving standard treatment plus zoledronic acid.
Main inclusion criteria: Patients must have confirmed high-grade osteosarcoma and be between 5 and 50 years old. They must not have any medical reasons preventing them from receiving planned treatments and must not have received chemotherapy or radiation therapy before. Women who can have children must use effective contraception, and patients must be able to have long-term follow-up. Registration must occur as soon as consent is given, no later than the third day after starting the first course of chemotherapy.
Main exclusion criteria: Patients with a different type of cancer than high-grade osteosarcoma, those outside the age range, and patients unable to undergo required treatments such as chemotherapy or surgery cannot participate. Those with medical conditions making the study treatments unsafe, pregnant or breastfeeding patients, and those unable to follow study procedures are also excluded.
Focus and goal: The trial monitors progression-free survival and assesses how long patients remain free from cancer progression. It evaluates overall survival rates, the body’s response to treatment, impact on bone health and quality of life, and includes biological studies to better understand treatment effects. The primary endpoint is event-free survival at 3 years.
Investigational drug: Zoledronic acid (Zometa 4 mg/100 ml solution) is administered intravenously as part of the treatment regimen combined with chemotherapy and surgery. It works by inhibiting an enzyme involved in bone resorption, which helps strengthen bones and prevent fractures.
Summary
The six clinical trials for osteosarcoma represent diverse approaches to treating this challenging bone cancer. A notable concentration of trials is taking place in France and Germany, with additional studies across Spain, Italy, Czechia, and Denmark, reflecting strong European collaboration in sarcoma research.
The trials span different treatment strategies: two focus on advanced immunotherapy using GD2IL18CART for relapsed or refractory cases, including long-term safety monitoring; two investigate medications that enhance standard chemotherapy (mifamurtide and zoledronic acid); one explores combination immunotherapy with cobolimab and dostarlimab across multiple tumor types; and one examines the combination of trabectedin with radiation therapy for advanced sarcomas.
Most trials include broad age ranges, from young children to middle-aged adults, reflecting the disease’s impact across different life stages. The studies address both newly diagnosed high-risk cases and relapsed or refractory disease, offering options for patients at various stages of their treatment journey. All trials emphasize careful monitoring of safety, effectiveness, and long-term outcomes, aiming to improve survival rates and quality of life for patients with osteosarcoma.
