Ongoing Clinical Trials for Metastases To Central Nervous System
There are currently 6 ongoing clinical trials investigating new treatments and diagnostic approaches for metastases to the central nervous system. These trials are being conducted across Europe, including France, Spain, Sweden, Netherlands, Norway, Italy, and Germany, and involve various innovative therapies ranging from targeted antibodies and immunotherapy to imaging techniques and repurposed medications.
Clinical trial locations
- France
- Germany
- Italy
- Netherlands
- Norway
- Spain
- Sweden
Evaluation of Bevacizumab in Patients with Brain Radionecrosis After Radiation Treatment for Brain Metastases
This French trial investigates a complication that can occur after radiation therapy for brain metastases, called brain radionecrosis, where brain tissue becomes damaged following treatment. The study compares whether adding bevacizumab to standard corticosteroid treatment is more effective than corticosteroids with placebo.
Main inclusion criteria: Participants must have radionecrosis confirmed by MRI and nuclear medicine imaging following brain radiation therapy. They must have persistent or worsening symptoms despite taking corticosteroids at a dose of at least 1 mg/kg/day for at least 2 weeks. The last brain radiation treatment must have been at least 3 months ago. Patients must be at least 18 years old with adequate physical functioning, a life expectancy of at least 3 months, and normal organ function including healthy blood cell counts, normal blood clotting, good kidney function, and normal liver function.
Main exclusion criteria: The trial excludes patients over 65 years old, pregnant or breastfeeding women, those with active bleeding or high bleeding risk, history of serious allergic reactions to bevacizumab, uncontrolled high blood pressure, major surgery within the last 28 days, unhealed wounds or ulcers, serious heart conditions, active infections requiring treatment, severe kidney or liver dysfunction, and current use of blood thinning medications that cannot be safely discontinued.
Focus and goal: The trial aims to determine if bevacizumab can help reduce symptoms of brain radionecrosis by decreasing abnormal blood vessel growth and swelling in the brain. Treatment involves prednisolone tablets combined with either bevacizumab or placebo given through intravenous infusion over three months. Doctors will monitor how well the treatment works by measuring changes in corticosteroid dose requirements, evaluating neurological symptoms, tracking brain changes using medical imaging, and assessing quality of life. Follow-up monitoring continues for up to two years to observe long-term effects.
Investigational drugs: Bevacizumab is a medication that helps reduce abnormal blood vessel growth and swelling in the brain, commonly used to treat various types of cancers and their complications. In this trial, it is being studied for its potential to help patients who have developed tissue damage in the brain after receiving radiation therapy. Corticosteroids are used as standard treatment to reduce inflammation and swelling in the brain.
Study of AZD9574 and Temozolomide for Patients with Advanced Solid Tumors, Including Breast, Ovarian, Pancreatic, and Prostate Cancers
This trial, conducted in Sweden and Spain, focuses on testing a new medication called AZD9574 for patients with advanced solid tumors. The study involves patients with IDH-mutant glioma and various advanced or relapsed cancers such as HER2-negative breast cancer, ovarian cancer, prostate cancer, and pancreatic cancer, particularly those with specific genetic mutations like BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.
Main inclusion criteria: Participants must provide signed and dated written consent, be at least 18 years old, and have an ECOG performance status of 0 to 2, meaning they can perform daily activities with no significant deterioration. They must have a life expectancy of at least 12 weeks and cancer that is getting worse at the time of joining. Participants need confirmation through tests of advanced cancer that meets specific eligibility criteria and disease that can be evaluated. They must have adequate organ and bone marrow function, and female participants who can have children must have a negative pregnancy test and use effective birth control.
Main exclusion criteria: The trial excludes patients who do not have the specific types of cancer being studied, those without the specific genetic mutations being studied, patients with breast cancer that has spread to the brain, those not within the specified age range, and patients who are not able to safely participate due to other health conditions or factors.
Focus and goal: The purpose is to assess the safety and tolerability of AZD9574 in patients with advanced cancers. Participants receive the medication in the form of a film-coated tablet taken orally. The study monitors how the body processes the drug, its effects on the cancer, and any side effects that may occur. Some participants may receive a placebo for comparison. The study also explores how the drug affects specific biomarkers, which are indicators of how the body is responding to treatment, and involves regular health checks including blood tests and imaging scans.
Investigational drugs: AZD9574 is an experimental medication being tested for its potential to treat advanced solid tumors, both on its own and in combination with other anti-cancer treatments. In some cases, AZD9574 is combined with other medications such as temozolomide, which is administered in the form of a hard capsule taken orally. The combination aims to enhance treatment efficacy and is tailored to the specific type of cancer being treated.
Study of SGM-101 fluorescent antibody to detect brain metastases from colorectal cancer during surgery
This Dutch trial evaluates a new imaging method using SGM-101 for patients with brain metastases that have spread from colorectal cancer. The research aims to determine how well SGM-101 can help surgeons detect and locate brain metastases during surgery.
Main inclusion criteria: Participants must sign an informed consent form, be over 18 years old, and have a confirmed diagnosis of brain metastasis from colorectal cancer scheduled for surgical removal. They must be able to communicate effectively in Dutch and follow study requirements. Women who can become pregnant and all men must use effective birth control during the study and for at least 30 days after the last treatment.
Main exclusion criteria: The trial excludes patients under 18 years, those unable to provide informed consent, pregnant or breastfeeding women, known allergy to fluorescent dyes or similar substances, active infection at the surgical site, participation in another clinical trial within the past 30 days, history of severe allergic reactions to medications, serious medical conditions that could interfere with surgery, previous brain surgery in the area to be operated, impaired kidney function, use of medications that could interact with the study drug, mental conditions affecting the ability to follow procedures, history of adverse reactions to surgical procedures, inability to undergo MRI scanning, and life expectancy less than 3 months.
Focus and goal: SGM-101 is a fluorescent antibody that attaches to specific markers found on cancer cells, making them visible during surgery. The medication is given through intravenous infusion before the surgical procedure. During the operation, doctors use a special camera system called the Quest Spectrum System to see the areas where the fluorescent medication has attached to cancer cells. The study involves a single dose of up to 15 milligrams of SGM-101, and patients undergo their planned brain surgery while doctors use the fluorescent imaging system.
Investigational drugs: SGM-101 is a specialized imaging agent that combines an antibody targeting a specific protein called carcinoembryonic antigen with a fluorescent dye. This medication is designed to help surgeons better see colorectal cancer that has spread to the brain during surgery. When given to patients before surgery, it attaches to cancer cells and makes them glow under special lighting, helping doctors to identify and remove cancer tissue more precisely.
Study on the Effects of Losartan Potassium on Brain Tumors in Patients with Glioblastoma or Brain Metastases from Non-Small-Cell Lung Cancer
This Norwegian trial studies the effects of losartan on certain types of brain tumors, including glioblastoma and brain metastases from non-small-cell lung cancer. The treatment involves using different doses of Cozaar, which contains the active ingredient losartan potassium.
Main inclusion criteria: Participants must have a confirmed diagnosis of either glioblastoma or at least one confirmed brain metastasis from non-small-cell lung cancer. They must provide documentation on specific genetic markers related to the disease. Organ functions must be strong enough to handle the study treatment. Female patients who can have children must use highly effective birth control methods and avoid pregnancy during the study and for at least 14 days after the last dose. Patients must be able to understand and willing to sign a consent form, able to undergo an MRI exam, have a measurable brain tumor, be at least 18 years old, have an ECOG performance status of 2 or less, and have a life expectancy of more than 3 months from the start of treatment.
Main exclusion criteria: The trial excludes patients with other types of cancer not specified in the study, those who have had previous treatment that might interfere with study results, patients with severe medical conditions that could make participation unsafe, those unable to follow study procedures, pregnant or breastfeeding patients, those participating in another clinical trial at the same time, patients with allergies to the study medication or its ingredients, those who have had recent major surgery, patients with uncontrolled high blood pressure, and those with severe liver or kidney disease.
Focus and goal: The purpose is to understand how losartan affects blood flow and the pressure caused by solid stress in brain tumors. Participants take the medication orally over a period of time, and their progress is monitored through various medical imaging techniques such as MRI. These imaging techniques help in assessing changes in blood flow and the physical stress within the tumors. The study also tracks changes in neurological performance and quality of life using established scoring systems like the Karnofsky Performance Score and the Eastern Cooperative Oncology Group scores.
Investigational drugs: Losartan is a medication used in this study to explore its effects on blood flow and mechanical stress in brain tumors. It works by blocking certain receptors in the body, which can help relax blood vessels and improve circulation. The study aims to understand how different amounts of losartan can influence these factors in patients with brain tumors.
Study of Ipilimumab and Nivolumab with or without Radiotherapy for Patients with Melanoma Brain Metastases
This Italian trial investigates treatments for melanoma brain metastases, a condition where melanoma has spread to the brain. The study uses two medications: YERVOY (ipilimumab) and OPDIVO (nivolumab), given as a solution through intravenous infusion.
Main inclusion criteria: Participants must be 18 years of age or older with a life expectancy of more than 30 days. They must be able to undergo an MRI scan with Gadolinium contrast dye and have adequate blood, liver, and kidney function. Women who can have children must have a negative pregnancy test and use effective birth control. Men with female partners who can have children must use effective birth control and not donate sperm during the study and for 31 weeks after treatment ends. Patients must have melanoma that has spread to the brain and cannot be removed by surgery, with brain tumors between 5mm and 40mm in size and measurable by specific guidelines. They must know their BRAF mutation status before being randomly assigned to a treatment group, have no symptoms from brain tumors at the time of joining, and have an ECOG performance status of 0-2.
Main exclusion criteria: Patients who are not within the specified age range, those who belong to certain clinical trial groups not included in this study, and patients who are part of a vulnerable population cannot participate.
Focus and goal: The purpose is to compare the effects of using these medications alone versus using them together with a type of targeted brain radiation called stereotactic radiotherapy. The study aims to understand how these treatments can help manage the disease and improve outcomes for patients. Participants receive either the combination of medications and radiation or just the medications. The trial monitors the effects of these treatments over time, focusing on how they impact the brain metastases and overall health, and looks at the rate of neurological-specific death at one year after starting treatment.
Investigational drugs: Ipilimumab is a type of medication known as an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells more effectively. Nivolumab is another immune checkpoint inhibitor that helps boost the immune system’s response against cancer cells. Intracranial stereotactic radiotherapy is a precise form of radiation therapy that targets tumors in the brain, delivering high doses of radiation directly to cancer cells while minimizing damage to surrounding healthy tissue.
Study Comparing Fluciclovine (18F) and Fluoroethyltyrosine F-18 PET Scans in Patients with New or Recurrent Brain Tumors and Brain Metastases
This German trial focuses on studying brain tumors, specifically cerebral gliomas and brain metastases. The trial involves patients who have been newly diagnosed with these conditions or have experienced a recurrence. The study uses two different imaging agents, 18F-Fluciclovine and 18F-Fluoroethyltyrosine, both solutions for injection.
Main inclusion criteria: The patient must be 18 years old or older, mentally and physically able to understand the importance and details of the study and follow instructions. They must have the ability to make decisions and have signed a written informed consent form before joining the study. Patients must be referred to the Nuclear Medicine Clinic of the University Hospital Aachen for a specific brain scan called FET PET, based on their doctor’s recommendation. They must have a suspected glioma before having a biopsy or surgery, or a suspected tumor recurrence after previous treatment for a brain tumor or brain metastasis.
Main exclusion criteria: The trial excludes patients who do not have newly diagnosed or recurrent cerebral gliomas or brain metastases, individuals who are not within the specified age range, participants who are not part of the specified clinical trial groups, and people who are considered part of a vulnerable population.
Focus and goal: The purpose is to compare how well these two agents work in showing the size and spread of tumors in the brain. These agents help in visualizing the tumors during a PET scan, which stands for Positron Emission Tomography. Participants receive injections of these imaging agents and then undergo PET scans. The study looks at how the images from the two different agents compare in terms of showing the tumor’s size and how the agent spreads in the brain. This will help doctors understand which agent might be more effective for certain types of brain tumors. The trial also assesses how accurately these agents can differentiate between tumor growth and changes related to previous treatments.
Investigational drugs: 18F-Fluciclovine is a type of imaging agent used in PET scans that helps doctors see certain types of brain tumors more clearly. 18F-Fluoroethyltyrosine is another imaging agent used in PET scans. The trial aims to see how effectively it can show the size and distribution of brain tumors compared to 18F-Fluciclovine.
Summary
The six ongoing clinical trials for metastases to the central nervous system represent a diverse range of research approaches across multiple European countries. A notable concentration of trials is taking place in Western Europe, with France, the Netherlands, Norway, Italy, and Germany each hosting individual trials, while Spain and Sweden share participation in one multi-country study.
The trials reflect different therapeutic strategies. Two trials focus on immunotherapy approaches, including the Italian study investigating ipilimumab and nivolumab for melanoma brain metastases, and the Swedish-Spanish trial examining AZD9574 for various advanced solid tumors. Two trials are exploring novel imaging techniques to improve surgical outcomes and tumor detection: the Dutch study using SGM-101 fluorescent antibody for colorectal cancer metastases, and the German study comparing different PET scan imaging agents. The remaining trials investigate treatment of radiation-related complications using bevacizumab in France, and the repurposing of losartan for brain tumor management in Norway.
The variety of approaches, from targeted therapies and immunotherapy to advanced imaging and repurposed medications, demonstrates the breadth of current research efforts aimed at improving outcomes for patients with central nervous system metastases.
