Mesothelioma is a rare type of cancer caused by exposure to asbestos. Only about 3,000 new cases are diagnosed in the United States each year, making it a rare and difficult to understand the disease.
In recent years, an increase in mesothelioma clinical trials has shed light on the disease and how it forms and reacts in the body. New treatment options have also been developed as a result of this new mesothelioma research.
But, what exactly are clinical trials? To put it simply, clinical trials are studies that allow researchers to identify the effectiveness of treatments for a group of people with a specific disease (in this case, mesothelioma).
Patients in clinical trials enroll on a voluntary basis, and the total amount of people in any given trial can range from a few dozen to a few thousand. The goal, of course, is for researchers to identify trends in the treatment process and make conclusions based on that. If a particular treatment option proves to be successful at treating the disease, then more trials are likely to follow.
Anyone can theoretically join a clinical trial if they meet the criteria for that specific study. In some cases, trials may be active but are no longer recruiting new participants. Most trials will look at a number of factors when deciding who they choose to study.
These factors can include:
- The patient’s age and gender
- Their overall health
- Type of mesothelioma (pleural, peritoneal, or pericardial)
- Whether any cancer treatments have already been administered
- The existence of any other medical conditions
- Stage of mesothelioma (stage 1 through 4 with stage 1 having the best prognosis)
Not everyone will meet the requirements of each trial. But, patients who are denied for one trial may qualify for another. It really depends on the individual research study and what they are looking for. Some clinical trials have very broad criteria like simply having a cancer diagnosis while others look for precise variables like having stage 3 pleural mesothelioma with the epithelioid cell type.
The Clinical Trial Process
Before mesothelioma clinical trials even start, most of the treatment methods have been studied for 6 years or more in a laboratory setting. Clinical trials usually represent the first human-based studies of the treatment method in question. Most trials are designed to investigate the efficacy of new medications for particular diseases, but that’s not always the case. Clinical trials can also look at non-medicine treatment options or procedures as well as diagnostic techniques.
In the United States, the Food and Drug Administration (FDA) sets guidelines for how clinical trials should be conducted. In general, they are carried out in 4 phases, starting with Phase I.
Phase I clinical trials are typically designed to identify five things:
- Safety of the treatment method
- It’s effectiveness
- Any associated side effects
- How the treatment is metabolized (if applicable)
- Proper dosage levels
Trials in this phase are usually much smaller than mesothelioma studies in later phases. Only around 20 to 50 participants are allowed to enroll. This is largely because the treatment method is unproven and its possible efficacy is only based on laboratory hypotheses, not actual evidence. Still, every new treatment method has to start off in these Phase I trials.
Phase II trials are usually larger, involving the study of between 200 and 300 participants. These trials usually occur after Phase I trials have deemed the treatment method relatively safe. Still, Phase II studies will continue to look at the safety of the treatment on a much broader scale. At this phase, researchers will also often compare existing treatment methods to the new one.
For instance, one patient group may be given the FDA-approved chemotherapy combination of pemetrexed and cisplatin while another group will be provided with chemotherapy drugs specifically being studied in the trial. They will then look at how those two treatment methods compare to one another in terms of disease reduction.
Phase III trials are usually the last step before a treatment receives FDA approval. They also have the largest study population of any phase usually reaching as high as 3,000. During this phase, researchers are looking to fine-tune dosage levels, monitor disease progress more thoroughly, and keep a close eye on side effects. Because this phase usually has the most participants, the data available will be much more exhaustive.
In some cases, Phase IV trials are necessary even after FDA approval. These are usually conducted to understand the long-term effects of the treatment method further. They may also be used to study how the treatment affects different types of disease. For instance, trials for the treatment method in Phases I through III usually may look at how a treatment specifically affects pleural mesothelioma. But, a Phase IV trial for the same treatment may also monitor how the treatment works with peritoneal mesothelioma.
Usually, it takes about 8 years of clinical trials for new medications to obtain FDA approval. For mesothelioma, however, that timeline can be extended. Because of the relatively small number of cases, it can take between 12 and 15 years for new mesothelioma drugs to be approved by the FDA.
What to Expect with Mesothelioma Clinical Trials
Clinical trials are all conducted on a volunteer basis. Every participant must read and sign an informed consent form that identifies all known side effects and benefits of the treatment. The primary investigator or sponsor of the study will also lay out what’s known as a “master protocol.”
This provides participants with a list of all of the following:
- What the study is intending to do
- How long the clinical trial will last
- Criteria for eligibility
- How frequently tests, procedures, and/or dosages will be administered
- The number of participants needed for the trial
- How much information from the patient the study will use
If a patient meets eligibility requirements and is accepted into the trial, they will usually follow the schedule laid out in the master protocol. If any new side effects or risks are discovered at any point during the study, the sponsor of the trial must provide each patient with an updated informed consent form to sign. Participants can drop out of the study at any point.
There is no guarantee that any given participant will actually be administered the new treatment being studied. Many studies place patients in separate comparison groups. One group will be given the new treatment while another will be given an existing treatment that has already been proven effective. In some cases, a third control group will be given a placebo.
It is always unclear how positively the new treatment method will affect any patient. Again, there is no guarantee that the new treatment will produce a positive prognosis. Of course, it could also be the key to identifying the next breakthrough treatment for mesothelioma.
While a lot of mesothelioma research looks to test the efficacy of new chemotherapy drugs, there are also plenty of new and emerging treatments being studied in clinical trials.
Some of these treatments include:
- Immunotherapy – medications that cause an immune response in the system to attack cancer cells
- Epigenetic therapy – medications that change how DNA is processed to help produce a cancer-killing reaction
- Gene therapy – the process of replacing malfunctioning genes with normal ones to induce a healthier response
- Photodynamic therapy – shining light on photosensitizing agents in the bloodstream causing a reaction that produces cancer-killing agents
- Virotherapy – injecting cancer-killing viruses into the system
- Cryotherapy – using cold temperatures to kill cancer cells
Any of these treatment methods could be the next advancement in mesothelioma research. They could also help extend lifespans and quality of life for a large portion of patients.
Costs of Clinical Trials
For many individuals, the cost of joining a clinical trial will be covered at least partially by their insurance. Patients who are over 65 can use Medicare to cover the costs associated with Phase II or Phase III trials that are sponsored by the government. Veterans may also qualify for VA benefits to help them offset the cost of a clinical trial.
For participants with no insurance, costs can include:
- Hospital stays
- Lab tests
- Imaging scans
- Visits to the doctor
In many cases, however, the sponsor of the clinical trial will cover all or most of the costs of the clinical trial.
Sponsors for clinical trials often include:
- Pharmaceutical companies
- Government organizations
Drug companies have the most motivation to pay for clinical trials because they often want to get medications to market more quickly. So, they may be more inclined to offer to pay for all associated treatment costs. Government organizations and universities are often given hefty grants to perform research on a wide variety of diseases.
While they may not have as many funds as pharmaceutical companies, they will often still be able to cover most of the major expenses of the treatment regimen they are administering.
Why Join a Mesothelioma Clinical Trial?
Mesothelioma is an extremely dangerous disease. It acts fast in producing tumors and destroying healthy cells throughout the body. Most patients survive only between a year and 21 months after diagnosis. Patients are often diagnosed in the latter stages of the disease’s progression making it difficult to treat in a curative sense.
For many mesothelioma sufferers, this outlook is grim and unacceptable. But, that’s why mesothelioma studies are so important. There’s a possibility that clinical trials will help the patients taking part in them.
Beyond that, though, almost all mesothelioma clinical trials will help future victims of the condition. As more research is compiled, the medical community continues to understand more about the disease every day.
For many people, joining a clinical trial is an act of self-preservation. But the value they provide to future mesothelioma sufferers will also be vital. The National Institutes of Health (NIH) keeps an updated list of all ongoing clinical trials in the United States at Clinicaltrials.gov.
If you are interested in joining a clinical trial, then visit that site and possibly consult with your doctor or local cancer center. It is only a matter of time before a mesothelioma clinical trial produces a cure for the disease.