Category: Research
How Clinical Trials Play a Role in Finding Cures and Treatments for Mesothelioma
Science is advanced through research, and the research process begins with clinical trials. Many us of have grown more familiar with the clinical trial process with the search for a vaccine for COVID-19. As the search continues for a cure for malignant mesothelioma, it is imperative that people involved in the mesothelioma community continue to be aware of what scientists are researching at this point for potential cures and quality life-extending treatments.
Chemotherapy has been the standard of care for patients with malignant pleural mesothelioma since it was approved by the FDA in 2004. Scientists continue to discover what the best methods to administer chemotherapy for malignant mesothelioma are. The usual route of administration is intravenously every three weeks for a 6 cycle treatment. In general, chemotherapy can be absorbed by mouth, intravenously, intramuscularly, subcutaneously, intraperitoneally directly into the abdomen, intravesicular directly into the bladder, intrapleurally into the pleural space, through implantable devices, topically, and intra-arterially. Intra-arterial chemotherapy is given directly into the artery that is supplying the blood to the tumor. It is done through angiography a special x-ray using dye to see the blood vessels.
NCT02611037 is a clinical trial that is currently being offered at the Lee Moffitt Center in Tampa, Florida. This is a unique trial that offers chemotherapy through a different approach by administering the chemotherapy intra-arterially, directly into the artery that is supplying the blood to the tumor. The chemotherapy is administered by angiography using a special x-ray dye to see the blood vessels.
One of the main challenges of treating malignant pleural mesothelioma is the location of the disease within the human body. The purpose of this study is to deliver transarterial chemoperfusion treatment with cisplatin, methotrexate, and gemcitabine in a safe and effective manner. This procedure is performed by an interventional radiologist, who injects one third of the drug into the internal mammary artery which supplies the blood supply to the pleura. The other two thirds of the drug are then injected into the descending aorta. This area of the body also has blood vessels that supply blood to the pleura. The procedure usually takes one hour and is followed by a one hour post-recovery period before patients are discharged.
In this study, patients undergo angiogram and transarterial chemo administration treatment every 4 weeks (3-6 weeks interval allowed) with cisplatin, methotrexate, and gemcitabine. The medications are administered into the thoracic aorta and/or the internal mammary artery.
Initial findings are promising. This treatment is safe and effective and may improve quality of life for patients who may not have many other options. For more information on the NCT02611037 trial, please go to www.clinicaltrials.gov or talk to your mesothelioma team.
New Dual-Immunotherapy Regimen Proves Effective for Mesothelioma Patients in Phase 3 Clinical Trial
Dr. Paul Baas of the Netherlands Cancer Institute and the University of Leiden in Amsterdam recently presented on the CheckMate 743 study at the International Association for the Study of Lung Cancer World Conference. The randomized phase III Checkmate 743 clinical trial prescribed mesothelioma patients who were not candidates for surgery with a combination of first-line nivolumab and ipilimumab.
The promising results yielded a four-month improvement in median overall survival for patients who received the new dual-immunotherapy regimen as compared with those who had received platinum-based chemotherapy, the current double-chemotherapy standard of care for mesothelioma.
“This is the first positive randomized trial of dual immunotherapy in first-line treatment of patients with unresectable MPM,” Dr. Bass noted. “And therefore nivolumab plus ipilimumab should be considered as a new standard of care.”
The patients featured in the phase III trial were randomly assigned treatment plans consisting of either a maximum of two years of nivolumab and ipilimumab, or six cycles of pemetrexed alongside cisplatin or carboplatin.
Results revealed that the treatment plan consisting of nivolumab and ipilimumab yielded comparable efficacy outcomes to chemotherapy for progression-free survival and objective response rate, but was significantly more successful than chemotherapy when it came to the duration of response (DOR). The DOR for the dual-immunotherapy treatment reached 11.0 months whereas the DOR for chemotherapy reached only 6.7 months.
“In the ipi/nivo survival curve, going out to 36 months, we see a plateau at about 30%,… suggesting, as we’ve seen with other trials of immunotherapy, there is a degree of durability that is way beyond what we’ve seen previously with chemotherapy. And this, indeed, may have been driven by maintenance nivolumab,” explained Dr. Dean Fennell of the Cancer Research UK Centre Leicester, University of Leicester and University Hospitals of Leicester NHS Trust.
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Clinical Trial of Imfinzi (Durvalumab) in Conjunction with Chemotherapy Yields Significantly Longer Survival Time for Patients Diagnosed with Malignant Pleural Mesothelioma
Immuno-Oncology News recently published results of a Phase 2 clinical trial of the immuno-checkpoint inhibitor Imfinzi (durvalumab) for patients diagnosed with malignant pleural mesothelioma.
The PrECOG cancer research group tested the effects of pairing Imfinzi, an AstraZeneca drug that blocks the activity of the PD-1 receptor in immune T-cells, with standard chemotherapy on a group of 55 individuals who had been recently diagnosed with inoperable malignant pleural mesothelioma. The PD-1/PD-L1 pathway affects inflammation, which causes pleural mesothelioma to develop at a faster rate.
The trial revealed that patients who took Imfinzi in addition to running out courses of standard chemotherapy (pemetrexed with cisplatin or carboplatin) survived for an average of 20.4 months, whereas patients who were given only standard chemotherapy lived for an average of 12.1 months. 81.8 percent of participants were male, their median age was 68, and three-quarters of them had been diagnosed with the epithelioid cancer subtype of malignant pleural mesothelioma.
“[Imfinzi] plus standard chemotherapy delivered a promising median overall survival rate for patients with previously untreated, inoperable malignant pleural mesothelioma,” affirmed Dr. Patrick Forde, director of the Kimmel Center’s thoracic cancer clinical research program, in a news release from the American Society of Clinical Oncology.
AstraZeneca, PrECOG, and the University of Sydney have plans to enroll participants who have been diagnosed with previously untreated, inoperable malignant pleural mesothelioma in a Phase 3 trial in Australia and the United States in September. More details about the upcoming clinical trial can be found here.
If you or a loved one has been diagnosed with mesothelioma, reach out today for a free consultation. Our experts can assist you with medical resources as well as options for compensation from those responsible.
Pairing Machine Learning with PET Scans Can Help Predict Mesothelioma Outcomes
The EJNMMI Research medical journal recently published an article entitled “FDG PET versus CT radiomics to predict outcome in malignant pleural mesothelioma patients” that outlines a study wherein 72 patients diagnosed with malignant pleural mesothelioma (MPM) at the University Hospital Zurich underwent pre-treatment FDG PET and CT scans alongside curative treatments. In the study, Swiss researchers discovered that using machine-learning radiomics models in conjunction with PET scans to track tumor progress can help doctors better predict outcomes of malignant pleural mesothelioma.
Malignant pleural mesothelioma is a form of cancer caused by exposure to asbestos and makes up 60 to 70 percent of all cases. MPM occurs when tumors develop in the lining of the lungs and chest cavity (called the pleura).
To obtain imaging that will help them diagnose mesothelioma and prescribe treatment for patients, doctors use both CT scans, which combine several x-ray scans from different angles, and PET scans, which use a radioactive tracing fluid to demonstrate tissue and organ functions.
While they did not have the same results with CT scans, the Swiss research team was able to develop a quantitative model using machine learning to more effectively analyze PET scans and predict the movement of tumors.
Because treating mesothelioma often involves varying approaches and exposes patients to many chemicals, it is critical that doctors are able to determine a course of action for each patient that is most responsive to their individual cancer. Malignant pleural mesothelioma is an aggressive cancer that spreads rapidly, so it is imperative that patients begin receiving treatment as quickly as possible.
If you or a loved one has been diagnosed with mesothelioma, reach out today for a free consultation. Our experts can assist you with medical resources as well as options for compensation from those responsible.
New Study Shows LMB-100 Can Be Even More Effective Paired with Keytruda for Mesothelioma Treatment
A new study published by the Science Translational Medicine journal showed that, for a small cohort, LMB-100 could be even more effective when paired with Keytruda for treating patients with mesothelioma. Researchers saw a median survival rate of almost a year, with a handful of clinical trial participants continuing to show progress after more than three years.
Following this success, the National Cancer Institute is currently accepting clinical trial participants for phase 2 of the study.
LMB-100 is an immunotoxin drug designed to help the immune system find and destroy cancer and mesothelioma cells.
Keytruda, an antibody drug used in cancer immunotherapy manufactured by Merck and also known as Pembrolizumab, has been approved by the FDA over the years for several treatments including solid tumor cancers and non-small cell lung cancer.
The study showed that patients taking both LMB-100 and Keytruda (pembrolizumab) could result in more effective treatment.
“In some of the patients, receiving pembrolizumab after LMB-100 resulted in greater efficacy than what would be expected from pembrolizumab alone,” said Raffit Hassan, M.D., Chief of the Thoracic and GI Malignancies Branch at the National Cancer Institute.
Patients diagnosed with malignant mesothelioma are encouraged to speak with their oncologist or consult with a Mesothelioma Center of Excellence to determine whether Keytruda or other medications can be an effective treatment, or whether they might be a candidate for a clinical trial. We at MesotheliomaHelp.org are always available to assist you.
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