For people with mesothelioma, sometimes the traditional treatments – chemotherapy, radiation, and surgery – may not be effective. That is why some patients turn to clinical trials to treat their asbestos cancer. Some clinical trials can offer hope to patients who otherwise might not have any.
Purpose of Mesothelioma Clinical Trials
Researchers are always searching for cures for mesothelioma. They also are looking for better diagnostic tools to assist with earlier detection and better treatment choices. Clinical trials are a way for specialists to experiment with new treatments for asbestos cancer patients. This can be very helpful for patients in stage IV that have not responded to regular therapies.
Phases of Mesothelioma Clinical Trials
If a new cancer clinical trial is considered successful, it might be considered for FDA approval and ready for patients who are not in clinical trials. To get FDA approval, the trial must go through three or four phases:
- Phase I: Conducted with small groups of patients to determine if the treatment is safe and effective.
- Phase II: Conducted with a larger group of patients to get a better handle on safety and effectiveness. May be used to compare treatments. If it shows promise, a phase III trial may follow.
- Phase III: Comparison studies are done during a phase III trial to observe the effects of new treatments on large groups of people. They are monitored for side effects. An improvement over a current therapy may lead to FDA approval.
- Phase IV: A treatment may be approved by the FDA but will continue to be studied.
List of Mesothelioma Clinical Trials
If you have mesothelioma and want to participate in a clinical trial, talk to your healthcare provider. Below are some of the current clinical trials for mesothelioma patients. (Mskcc.org). For more information on these trials, please visit the Memorial Sloan Kettering Cancer Center website.
#1 A Phase I Study of a Targeted Cancer Vaccine (Galinpepimut-S) Combined with Nivolumab Immunotherapy in Patients with Persistent Pleural Mesothelioma
Summary: Purpose of the clinical study is to assess safety and effects of a cancer vaccine that is provided with nivolumab immunotherapy in patients who have pleural mesothelioma that continues to spread despite treatment. It is called galinpepimut-S and it targets the protein WT1, which is found on the surface of some mesothelioma cells. It is mixed with montanide, and it increases the immune response.
Eligibility: You must have pleural mesothelioma that grows despite treatment with pemetrexed chemotherapy; you may not have previously been treated with immunotherapy with a drug such as nivolumab; you must be able to walk and do regular activities for at least ½ of your waking hours, and study is for patients 18+.
#2 A Phase I Study of Immunotherapy with Genetically Engineered T Cells (CAR T Cells) to Treat Mesothelioma and Malignant Pleural Disease from Lung and Breast Cancers
Summary: Researchers have found that the protein mesothelin is usually overexpressed in pleural mesothelioma. In this clinical study, researchers are trying to find the greatest dose of genetically modified T cells that can be effectively given to patients with pleural cancers that continue to grow.
The treatment features the use of the patient’s T cells and genetically modifies them in the lab to recognize mesothelin. The modified T cells are given back to the patient to kill cancer cells in the body.
Eligibility: Patients have to have mesothelioma or another type of cancer that has spread to the pleura; tumors must have the mesothelin protein; at least one month must have passed since any surgery or completion of chemotherapy or radiation treatment, and the study is for patients 18+.
#3 A Phase I/II Study of TC-210 Gene Therapy in People with Advanced Mesothelin-Expressing Cancers
Summary: The purpose is to find the highest possible dose of the drug TC-210 that can be given to cancer patients safely who have mesothelioma, metastatic lung cancer, ovarian cancer, or cholangiocarcinoma that produces a protein called mesothelin. TC-210 targets and kills cancer cells that feature mesothelin on the surface.
TC-210 is a type of gene therapy that is made of T cells that are taken out of the patient, modified genetically in the lab so they will attack and kill cancer cells. They are then put back in that patient.
Eligibility: Patients must have mesothelioma, ovarian cancer, metastatic lung cancer, or cholangicarcinoma that produces mesothelin; patient need to recover from other therapies before beginning the study; patients must be physically well enough that they can do self-care and are ambulatory, and study is for patients 18+
#4 A Phase II/III Study of Chemotherapy with or without ADI-PEG 20 in Patients with Malignant Pleural Mesothelioma
Summary: Arginine is a nutrient that is in proteins. Lab studies show that a drug called ADI-PEG 20 can break down arginine and destroy cancer cells. In this clinical trial, investigators want to determine if adding this drug to chemotherapy for pleural malignant mesothelioma will be more effective against the cancer than just chemotherapy.
Patients are given chemotherapy with pemetrexed or carboplatin, and randomly assigned to receive a placebo or ADI-PEG 20.
Eligibility: Patients must have pleural mesothelioma that has not been treated with immunotherapy or chemotherapy; if the patient has had surgery, it must be at least one month in the past; patients must be physically well enough that they can move about and can do self-care, and study is for patients 18+.
#5 A Study of Pevonedistat Alone and in Combination with Chemotherapy in Patients with Mesothelioma
Summary: The purpose of the study is to assess how safe and effective the investigational drug pevondistat is in patients with mesothelioma that is inoperable. Pevonedistat works against mesothelioma by stopping an enzyme that the cancer uses to grow.
Patients who had treatment for their mesothelioma previously will get pevonedistat alone. Those who have not had prior treatment will get the drug, plus standard chemo that includes pemetrexed and cisplatin.
Eligibility: The patient must have mesothelioma that is inoperable in the pleura or peritoneum; those with prior therapy must have gotten pemetrexed and a drug based on platinum. There must be at least three weeks’ passage between completion of earlier treatment and entry into the clinical study, and the patient must be 18 years or older.
#6 A Study of Stereotactic Body Radiation Therapy and Avelumab Immunotherapy to Treat Malignant Mesothelioma
Summary: This study assesses the safety and effectiveness of a type of radiation therapy called stereotactic body radiation or SBRT combined with an immunotherapy called avelumab to treat mesothelioma that is growing or came back after earlier treatment. SBRT provides high-dose radiation therapy with effectiveness and high effectiveness with one to five treatments.
Avelumab is a type of antibody that works by blocking a protein on tumor cells – PD-L1. Tumor cells produce PD-L1 to help them to evade immune system detection. When this protein is blocked, avelumab can improve the ability of your immune system to kill cancer cells.
Eligibility: Patients must have recurrent or persistent mesothelioma that is still growing or returned after treatment that included pemetrexed and a drug containing platinum; must have recovered from side effects of previous therapies; the patient cannot have had prior immunotherapy; the study is for patients 18+.
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