Clinical Trials for Mesothelioma Treatment: What to Expect

If you’ve been diagnosed with malignant mesothelioma, you may be exploring different treatment options. One option you may have heard of is participation in clinical trials for experimental treatment methods not currently approved by the Food and Drug Administration to be on the market. For nearly every drug that is on the market today, a clinical trial was first conducted in order to establish the safety and efficacy of the drug before releasing it to the public for consumption.

What are Clinical Trials?

A clinical trial is the process of administering a treatment to a select group of people and monitoring the results in order to establish the safety and effectiveness of that treatment for a given disorder. For clinical trials related to mesothelioma treatment, the process usually involves a “testing out” of a given chemotherapy drug.

There are definitely risks to participating in clinical trials, as the treatments being studied are experimental and the purpose of the trial is to determine not only how effective the treatment might be, but also whether or not the treatment is safe. However, for people with an aggressive form of cancer like mesothelioma, the risks are often determined to be worth the potential benefits because effective treatment options for mesothelioma are so limited.

Who may Participate in Clinical Trials?

Each trial will have a specific set of criteria that must be met by potential participants in order to qualify for the study. Anyone who meets those criteria may participate, though the criteria do vary widely from trial to trial.

Some trials will involve people of specific demographics (such as people of a particular gender or age range), and some trials will only focus on participants with a certain type of mesothelioma (for example, a trial may be conducted to a determine the safety and efficacy of a new drug on malignant pleural mesothelioma, but not pericardial or peritoneal mesothelioma). People who wish to participate can first expect to be given a questionnaire to determine if they meet the criteria for qualification for that particular trial.

The Clinical Trial Process

The process for all clinical trials, though they may differ greatly in terms of the type of treatment being studied, is loosely the same across the board. Each trial must be conducted according to experimental research standards in order to meet approval guidelines set forth by the FDA. Thus, whether the trial is studying a chemotherapy drug, a new type of radiation treatment or a novel multimodal approach to treatment, it will be conducted in the same manner as all clinical trials.

Phases

There are always at least three phases to a clinical trial prior to FDA approval, and often a fourth phase is conducted over the long term even after FDA approval has been secured and the treatment has been made available to the general public.

• Phase 1: The first clinical trial phase involves administering the proposed treatment to a very small subset of the population that the treatment is suspected of being beneficial to. In this phase, dosages and treatment administration methods are established and the first reports of side effects are recorded.
• Phase 2: The second clinical trial phase expands the number of people being administered the potential treatment, using the guidelines for dosage and administration established in the first trial phase. In this phase, the treatment is studied extensively as its effect on the tumor is observed and recorded.
• Phase 3: The third clinical trial phase expands the number of participants even further, and involves the creation of a control group for the experiment. The control group is given a placebo—such as an already-established form of chemotherapy, rather than the novel treatment being studied—in order to compare the treatment being studied to standard treatments. If the results for the new treatment are overall positive for a significant enough number of participants, the FDA may then approve the treatment for use by medical professionals who treat malignant mesothelioma.
• Phase 4: The final phase of a clinical trial, the fourth phase continues to study the new treatment over the long term in order to establish if there are any risks or benefits to usage of the treatment over a period of years or even decades. This phase occurs in some trials after the FDA has approved the treatment to go on the market.

FDA Approval

If a treatment is shown to be successful—that is, safe and efficacious—following the third phase of the clinical trial, the FDA will likely approve the treatment and the treatment method will be made available to all people who may benefit from it.

Benefits of Participating in Clinical Trials

While participating in clinical trials simply to help further medical knowledge is altruistic, it is not realistic. The real motivation for people to participate is to benefit from a novel treatment or intervention. This is especially important for patients with an incurable disease, like late-stage mesothelioma. If you are living with this cancer, you may have little hope of a cure, but one of those small hopes is through a clinical trial. Although rare, it is possible that the intervention being tested will finally provide a cure or at least remission.

Risks of Participating

Of course there are big risks involved with participating in clinical trials. These are drugs and treatments that have not yet been tested on people. The participants are essentially human guinea pigs. There are protections in place, including informed consent. Participants must be provided with all necessary information by the researchers before agreeing to get involved in the study. The information should give a patient everything he or she needs to know about risks and potential benefits to make an informed decision. There are also institutional review boards that monitor and approve studies to make sure they proceed in a way that is ethical and that protects the participants.

Even with these measures in place, there are risks. For instance, if you are hoping to benefit from a new treatment, you may not even get to try it. Randomized, blind studies randomly assign the novel intervention to some participants. If this is the case with a trial you want to participate in, the researcher must inform you of this possibility before you begin. The other risks are related to the newness of the intervention. There may be side effects and complications that no one has foreseen.

Examples of Mesothelioma Clinical Trials

To find trials to participate in you can talk to your oncologist and medical team. You can also search the clinical trials listed by the National Institutes of Health. You can search for those trials that are actively recruiting and those that are looking for mesothelioma patients. One example of a trial currently seeking mesothelioma patient is testing a drug called atezolizumab.

This drug has already been approved by the FDA for other types of cancer, including lung cancer, but researchers need more opportunities to study its effect on mesothelioma. The drug works by targeting protein in the body that prevents the immune system from attacking cancer cells. It is an immunotherapy drug, a promising new class of medications being used to treat cancer.

Another exciting new clinical trial recruiting mesothelioma patients is investigating the use of the measles virus to treat pleural mesothelioma. The virus is genetically modified and has been shown to be able to kill cancer cells in laboratory cultures. If injected into human subjects, the altered virus may attack and kill cancer cells.

Finding a Trial to Participate in

If you are interested in participating in a clinical trial for mesothelioma treatment, talk to a member of your cancer care team about your desire to take part. One of your doctors will likely know the right places for you to look into participating in a clinical trial in your area, and can get you started by helping you fill out application paperwork to get your own clinical trial participation ball rolling.

If you are hoping to participate in a clinical trial for treating any type of mesothelioma, be sure that you understand the risks and talk to your medical team extensively before deciding to go through with it. You have to be sure that you are eligible and that you are willing to take the risks of trying an untested new medical treatment. For many patients with mesothelioma, this is an easy choice. It is a terrible type of cancer with no known cure, so to risk a clinical trial with a novel treatment is often a smart option. Talk to your doctors, ask all the questions you have, and also talk to your loved ones before making a final decision about a clinical trial.