Mesothelioma clinical trials are used to test experimental treatments, screening methods, and diagnostic methods. If a malignant mesothelioma patient meets certain criteria, they could be eligible for a clinical trial. Participating in a clinical trial could give
What Are Clinical Trials?
A clinical trial is a carefully controlled study that uses human participants to test the safety and effectiveness of a medical treatment. The treatment could be a drug, a medical device, a surgical technique, or a behavioral change. All new treatments must go through clinical trials before gaining approval by the Food and Drug Administration (FDA).
Clinical trials are available for all types and stages of mesothelioma. They involve treatments like immunotherapy, radiation, vaccines, and other experimental therapies.
Why Participate in a Mesothelioma Clinical Trial?
Participating in a clinical trial allows a mesothelioma patient to receive cutting-edge treatment that isn’t yet available to the public. Clinical trials test the safety and effectiveness of a new treatment, so a certain level of risk is involved. However, clinical trials often feature the most effective and promising new treatments for mesothelioma. If a mesothelioma patient’s tumor doesn’t respond well to traditional treatment options, they may find success during a clinical trial.
Clinical trials also offer hope for future mesothelioma patients. Mesothelioma is a rare disease, which makes it hard to research and study well. Participating in a clinical trial helps to advance mesothelioma research and expand treatment options…
Clinical Trial Criteria
Clinical trials may enroll patients with a specific type of mesothelioma, a specific stage of mesothelioma, or a specific mesothelioma cell type. Some trials may also seek out very specific mesothelioma characteristics, like pleural mesothelioma that cannot undergo surgical treatment.
Each clinical trial has its requirements for participation, and not everyone will qualify. Clinical trial enrollment should always be discussed with the patient’s medical care team
Types of Clinical Trials
There are several different types of clinical trials. Each type has its own goal that depends on what the researchers are studying.
Common clinical trial types include:
- Treatment trials, which test the effectiveness of a treatment on a patient. Treatments can include medicine, new devices, or new surgical techniques.
- Prevention trials, which test ways to prevent new instances of mesothelioma. They also test ways to prevent relapsed mesothelioma in patients who have no visible tumor cells.
- Diagnostic trials, which study new ways of identifying and diagnosing mesothelioma.
Most mesothelioma trials are treatment trials.
Clinical Trial Phases
Clinical trials are conducted in 4 phases. This allows researchers to ensure patient safety in a smaller group before testing the treatment with a larger group. The study sponsors must present data demonstrating the treatment’s safety and effectiveness to the FDA to move from one phase to the next.
Phase I Trials
In a phase I trial, an experimental treatment is given to a small group of people, typically under 100 people, for the first time. Phase I participants are healthy volunteers, not people who have mesothelioma. Participants are carefully monitored for any adverse events. Researchers evaluate drug safety, appropriate dosage, and any side effects. A phase I trial is primarily focused on patient safety.
Phase II Trials
In a phase II trial, an experimental treatment is given to a slightly larger group of patients who have mesothelioma. This provides further data about the treatment’s safety and effectiveness. In some cases, a phase II study can last for years. A phase II trial is primarily focused on treatment effectiveness.
Phase III Trials
In a phase III trial, an experimental treatment is given to a larger group, generally a few hundred to a few thousand patients. This phase is focused on collecting enough data to be certain that the new treatment is at least as safe and effective as the existing treatments for the disease.
Usually, phase III trial participants are given either the experimental treatment or a placebo. A placebo is an inactive substance that looks like the treatment being tested but has no physical effect. In cancer clinical trials, placebos are rare and used only with the full knowledge of the participants. Instead, patients who don’t receive the experimental treatment receive a standard treatment, like chemotherapy or immunotherapy.
If the treatment is shown to be effective in Phase III, the data will be presented to the FDA for approval of the treatment. If the treatment receives FDA approval, it can then be prescribed to patients by their doctors outside the setting of a clinical trial.
Phase IV Trials
In a Phase IV trial, a treatment is studied after it has been approved by the FDA and released to the public. Researchers can now monitor long-term side effects and effectiveness, as well as new side effects that were not present in earlier trials. Phase IV clinical trials can include thousands of people.
Are Mesothelioma Clinical Trials Safe?
Before the treatment proceeds to clinical trials, they have already been tested extensively in a laboratory and have been deemed safe enough to proceed to clinical trials. The FDA must approve every new clinical trial, and they provide strong oversight throughout the process.
Clinical trials are very closely regulated by the FDA. Since experimental treatments are involved, however, researchers cannot guarantee safety.
Informed Consent and Institutional Review Boards
Following the FDA, every mesothelioma clinical trial is monitored by an institutional review board (IRB). This is an administrative board that reviews and monitors research involving human subjects. They have the right to approve, modify, or disapprove research done in clinical trials. The purpose of the IRB is to further protect the trial’s participants.
Clinical trials also require informed consent. This means that the patient is given a detailed explanation of the trial, their role in it, and the potential risks. The patient must also understand that they may not benefit from the trial.
Adverse Events and Side Effects
In clinical research, an adverse effect is an unwanted side effect of a treatment. In the United States, clinical trial sponsors are required to report adverse events to the FDA. If the experimental treatment is deemed to present an unreasonable risk to participants, then the study will be stopped and all participants will go back to receiving standard care.
How Are Mesothelioma Clinical Trials Funded?
Clinical trials usually need a sponsor to fund the study. These sponsors can include government agencies, pharmaceutical companies, and other institutions.
The U.S. Department of Defense has funded mesothelioma research through its Peer Reviewed Cancer Research Program since 2008. Mesothelioma researchers have received over $20 million from this program.
The Mesothelioma Applied Research Foundation, a nonprofit organization, was founded in 1999 to gain more research funding for mesothelioma. Since then, they have funded over $10.5 million in mesothelioma research projects.
Costs of Clinical Trials
The experimental treatment, the costs of administration, and specific tests required by the study will be paid for by the study sponsor. Some trials pay for more than this. For example, many studies will cover your travel costs if you need to travel to a center to receive study-related care. Before you enroll in a clinical trial, you should make sure you know which costs are covered.
Health insurance plans, including Medicare, are required to cover the routine health costs of any cancer patient who is enrolled in a clinical trial. This includes things like testing and doctor’s visits that would normally be a part of your mesothelioma treatment, even if you weren’t enrolled in a study. Your insurance is not allowed to deny payment for these items simply because you are enrolled in a trial. In general, your out-of-pocket expenses for your cancer care should not be increased by your participation in a clinical trial.
One Study At a Time
Although you may qualify for several different trials, it’s generally not possible to participate in more than one trial at a time. This is because taking two different experimental treatments at the same time would make it impossible for researchers to know which one affected you.
If your first trial ends, you may then be eligible to enroll in another mesothelioma trial.
Early Withdrawal
Patients are allowed to leave a clinical trial at any time, for any reason, without penalty. If you decide to leave a study, the researchers will ask you why. This helps them to determine whether you were suffering side effects of the treatment that they should know about, or if you’re leaving for other reasons.
It’s very helpful to answer these questions honestly to ensure that the clinical trial has the best possible data.
How To Find a Mesothelioma Clinical Trial
Your medical care team will generally know which clinical trials you are eligible for. If you’re interested in enrolling in a mesothelioma trial, you should discuss your options with your doctor. Patients can also research clinical trials themselves.
The National Institutes of Health maintains a searchable database of all past, present, and future clinical trials on ClinicalTrials.gov. Patients should also check the websites of major hospitals and research institutions, like The University of Chicago and The Mayo Clinic, which are both currently recruiting mesothelioma patients.
Recently completed mesothelioma clinical trials include:
- Olaparib in People With Malignant Mesothelioma, sponsored by the National Cancer Institute
- A Single Dose FMT Infusion as an Adjunct to Keytruda for Metastatic Mesothelioma, sponsored by ProgenaBiome
- Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma, sponsored by Kissei Pharmaceutical Co.
- Ipilimumab and Nivolumab in the Treatment of Malignant Pleural Mesothelioma, sponsored by The Netherlands Cancer Institute
