What Is a Mesothelioma Clinical Trial?
A clinical trial is a carefully controlled study on human participants that attempts to develop new and more effective ways to help people with a particular disease.
Mesothelioma clinical trials in particular are meant to advance treatment options for victims of mesothelioma.
Amy Fair, a nurse with over 20 years of mesothelioma experience, explains what clinical trials are, the types, and how to find them. View Transcript.
Duration: 1 min 31 sec
Besides the standard treatment right now of radiation, surgery, and chemotherapy there are ongoing clinical trials at some facilities that some patients may fit.
Clinical trials are the development of new and novel therapies.
You have to be a candidate and meet certain criterial for clinical trials. Some trials evolve around a certain type of mesothelioma. Some evolve around a certain age group.
There are exciting clinical trials out there now that involved immunotherapy, where they are strengthening and enhancing someone’s immune system to fight the disease. There are target and gene therapies currently in clinical trials that target someone’s DNA make up and molecular studies. These are still currently in several phases of clinical trials.
If you are interested in a clinical trial or your oncologist thinks you’re a candidate for a clinical trial the best way to learn is to start with your oncologist. They should be very knowledgeable about the clinical trials in your area. The National Institute of Health, on their website, has a tremendous amount of knowledge about clinical trials, the different phases that they are in and where these facilities are at that are involved in these clinical trials.
Many of today’s standard mesothelioma treatment options such as chemotherapy and targeted radiation were first tested in clinical trials to demonstrate safety and effectiveness before becoming available to the public.
Reasons patients may sign up for clinical trials include:
- Being diagnosed with a hard-to-treat type of mesothelioma such as late-stage or sarcomatoid mesothelioma
- Failure to respond to chemotherapy and/or radiation
- Mesothelioma that has come back after being in full or partial remission (recurrence)
- A desire to help future mesothelioma victims
Participating in a clinical trial can be an attractive option for a wide range of mesothelioma patients, offering the opportunity to receive the most cutting-edge treatments based on the latest expert research.
Mesothelioma patients interested in participating in clinical trials should speak with their doctor to see if a trial is right for them.
- The clinicaltrials.gov database listed over 200 mesothelioma clinical studies across the United States in April 2020.
- The FDA has strict laws and requirements to protect participants in clinical trials. According to the National Cancer Institute, clinical trials are only performed after years of lab research supports a treatment’s safety in people.
- According to the National Cancer Institute, the number one target for cancer immunotherapy is a protein called WTI. In 2020, the first mesothelioma patient entered a clinical trial testing a cancer vaccine capable of targeting this protein.
- The NovoTTF-100L is the first FDA-approved treatment option for mesothelioma in 15 years.
Benefits of Mesothelioma Clinical Trials
Clinical trials are essential to the treatment of mesothelioma, which often does not respond well to standard cancer treatment options (surgery, chemotherapy, and radiation).
Benefits of Mesothelioma Clinical Trials for Patients
Many of the most effective treatments for mesothelioma can only be performed on a small fraction of patients who are diagnosed early in the disease’s progression.
This means that patients who are not responding to standard treatment or whose disease returns are often out of standard options, but they do have the option of clinical trials.
Clinical trials offer alternative treatment options to patients who:
- Do not see improvement from standard treatment
- Have a bad reaction to standard treatment methods
- Are not considered good candidates for standard treatment
- Have their mesothelioma return after treatment
By participating in clinical trials for mesothelioma, patients not only get care from top specialists using the most advanced treatments — they also benefit everyone seeking to fight mesothelioma and anyone who will become a victim of this deadly cancer in the future.
Benefits of Mesothelioma Clinical Trials for the Medical Community
Clinical trials have important benefits for the broad mesothelioma medical community.
Given that mesothelioma is a relatively rare form of cancer, clinical trials add new knowledge to the existing body of research. Clinical trials tell doctors about the unique behavior of mesothelioma, how to effectively treat it, and methods for preventing it from spreading and recurring.
Clinical trials answer important questions for the medical community. Their results lead to deeper investigations so doctors become better at managing and treating mesothelioma and extending patient survival.
Numerous people with mesothelioma are now living longer due to the scientific discoveries made by clinical trials. Reach out to Mesothelioma Hope to learn more about clinical trials near you.
Mesothelioma Prognosis After a Clinical Trial
A mesothelioma prognosis describes the way a mesothelioma patient’s cancer is expected to progress. The prognosis for mesothelioma is generally poor, with only around 10% of pleural mesothelioma patients surviving 5 years after diagnosis, according to the American Cancer Society (ACS).
However, treatments being tested through clinical trials may improve the prognosis of some mesothelioma patients.
ACS lists some promising new mesothelioma treatment options as:
- Immunotherapy: Immunotherapy helps the body’s own immune system find and destroy cancer cells more effectively. Clinical trials are currently testing new immunotherapy drugs and exploring how these drugs can be best combined with other treatments for mesothelioma.
- Targeted therapy: Targeted therapy hones in on the unique traits of cancer cells to kill the cancer while leaving healthy cells alone. Targeted therapy drugs that attack mesothelioma cells are coming into use and being actively studied.
- Gene therapy: Gene therapy attempts to add new genes to cancer cells so that they are easier to destroy. This is a newer treatment type for mesothelioma clinical trials.
- New approaches to standard treatment: Many clinical trials are focused on testing novel approaches to standard treatment for mesothelioma or improved technologies for delivering standard treatment, for example, a more accurate radiation therapy device or a certain combination of chemotherapy drugs.
It is important to remember, however, that clinical trials exist to test the effectiveness of a new treatment, so doctors cannot say how helpful a treatment will generally be for a patient. They are not necessarily helpful for every individual participant.
“We have a lot of hope for our clinical trials. We wouldn’t be doing them if we didn’t. But they take more time from patients and the benefit is uncertain, which is why we’re testing them.”
– Christine Alewine, MD, PhD, National Cancer Institute
Patients should consider multiple factors when considering how likely a clinical trial is to help them, such as how new the treatment approach is and what phase of the study the trial is in.
Clinical Trial Phases
Mesothelioma clinical trials study a wide range of topics and are split into phases to ensure optimal safety and benefits.
Clinical trial phases start with smaller study populations that eventually grow from stage to stage if the treatment method being researched shows positive effects.
Initial tests are conducted on animals or in vitro human cells to see if the proposed treatment is safe for humans.
Small studies (10-15 people) focus on how the treatment will affect the human body.
These studies focus on determining the most tolerated dosage, the safest way to administer the treatment, and any associated side effects. These elements are determined by dividing the study population into groups, each at an increased dose, to see how the treatment affects each.
When side effects in a group become significant, the dose is capped at the level used in the previous group. Phase I studies may contain patients with different cancer types.
Information gathered in Phase 1 is used to see if the treatment is effective in fighting mesothelioma. Phase 2 clinical trials study more similar populations, usually the same cancer type, often smaller than 100 people. The goal is effectiveness, not only tolerability.
The researched treatment is administered to two similarly selected groups of pages, one of which gets the new treatment and the other placebo of standard therapy.
Patients are often assigned randomly into a group and double-blinded, meaning that neither those who conduct the study nor the patient know which arm of the study they are in. This helps researchers understand if the proposed treatment is more effective than standard treatments.
The new mesothelioma treatment is submitted to the United States Food and Drug Administration (FDA) for an extensive review of all the associated research. A decision is made at the end of the review whether the treatment is safe and effective, and therefore, available to the public.
After the drug is approved, long-term aftermarket studies may be conducted. These trials explore the impacts of the new therapy in greater detail to better understand the associated benefits and risks.
Patients should educate themselves on the various types and phases of clinical trials before deciding to participate.
Types of Clinical Trials for Mesothelioma
There are many types of clinical trials and if patients meet the eligibility requirements, they may have an opportunity to participate and benefit from research in various aspects of mesothelioma prevention, treatment, and management.
Types of mesothelioma clinical research studies include:
- Prevention studies: Looks at ways of preventing mesothelioma from occurring or recurring.
- Screening studies: Looks at improving or developing new mesothelioma detection methods
- Diagnostic studies: Tests methods for earlier identification of mesothelioma in patients with symptoms
- Treatment studies: Tests new treatment options, including new combinations of drugs and new approaches to standard treatment (surgery, radiation, and chemotherapy)
- Quality of life studies: Explore ways to manage symptoms of mesothelioma and the side effects of treatment
Clinical trials may attempt to develop improved methods for detecting mesothelioma at an earlier stage to give patients the best possible prognosis.
Detecting mesothelioma early can be extremely challenging, meaning that developing improved screening methods is a high priority within the medical community.
Researchers are testing new ways to reduce incidents of mesothelioma or controlling mechanisms to prevent it from recurring (coming back after treatment).
Since mesothelioma generally develops over years of exposure to asbestos, prevention clinical trials focused on disease prevention usually involve participants who are in remission (when visible signs of mesothelioma are gone) and whose time-course is much shorter.
Medical researchers look for better ways to diagnose mesothelioma, as the rare disease can be difficult for even experienced mesothelioma doctors to distinguish from other forms of cancer.
As misdiagnosis leads to putting the patient on an ineffective treatment plan and a poor prognosis, many clinical trials are dedicated to improving mesothelioma diagnosis methods.
Given the relatively low survival rates of mesothelioma, the majority of clinical trials are committed to finding improved mesothelioma treatment methods to increase patient survival.
These clinical trials may test new drug combinations or procedures within standard treatment methods (chemotherapy, surgery, and radiation) or the effectiveness of alternative therapies.
If a patient’s mesothelioma has progressed to the point where surgery is not possible, doctors may prescribe other treatments to help manage mesothelioma symptoms and increase their quality of life.
Mesothelioma management clinical trials may focus on improving quality of life through:
- New diets that improve overall health and a patient’s ability to fight mesothelioma
- Social supports that make patients feel more connected and empowered
- Pain management methods that improve comfort in the final stages of life
All of these mesothelioma clinical trial types play an important role in helping mesothelioma victims live longer and better with their disease.
What to Expect During a Mesothelioma Clinical Trial
The idea of undergoing a clinical trial may intimidate some mesothelioma patients. However, patients can rest assured that clinical trials in the United States are performed under strict oversight and to the highest ethical standard to protect the safety of patients.
Clinical trials usually require additional treatments and checkups.
Mesothelioma clinical trials may require more frequent:
- Blood tests
- Imaging tests
- Checkups and close monitoring
- Medications and other treatment
Individuals considering participating in a clinical trial should speak to their doctor and loved ones to understand the details of what is involved in a particular trial, including treatment frequency, length of the trial, restrictions, and travel requirements.
Where Do Mesothelioma Clinical Trials Take Place?
In general, clinical trials take place in the same location where a patient would receive standard mesothelioma treatments. Many clinical trials for mesothelioma take place at top mesothelioma cancer centers.
Mesothelioma clinical trials may take place at:
- Cancer centers
- Doctors offices
However, the location of a mesothelioma clinical trial ultimately depends on the therapy or technique that the trial is testing, as well as the phase of the trial.
These studies can take place in a single location, with a small study population, or across numerous hospitals, involving thousands of mesothelioma patients throughout the country.
Clinical trials are usually conducted in larger city centers, so many patients may need to travel in order to participate.
Clinical Trial Costs
There is typically little to no cost to mesothelioma patients for experimental treatment. The government or the company testing the drug often takes care of expenses.
However, mesothelioma patients will still need to cover the costs of standard treatment. In addition, there may be extra costs associated with participating in a clinical trial.
Clinical trial costs may include:
- Doctor visits
- Hospital stays
- Lab tests
- Imaging tests (X-rays, etc.)
Depending on the study and the individual participating, some or even all of these costs may be covered.
Treatment expenses may be covered by:
- Certain companies sponsoring larger studies
- Certain government-sponsored programs
- Private health insurance
Several factors may affect a patient’s insurance coverage of a clinical trial and related expenses.
A mesothelioma clinical trial’s consent form should include information about potential costs to participants and what is covered by the sponsor of the clinical trial.
Patients can reach out to their doctor and cancer care team for help with the details of a particular trial and how to cover associated costs.
Some patients may be eligible to pursue a mesothelioma settlement or asbestos trust fund compensation to help pay for treatment costs.
Are Clinical Trials Safe?
Clinical trials are generally safe, but as with all treatments, medical specialists cannot guarantee that experimental treatments will not cause participants any harm.
Potential risks and downsides of mesothelioma clinical trials include:
- Side effects
- Treatment that does not improve a patient’s mesothelioma
- More required visits
- Additional expenses
- Loss of an opportunity to pursue other treatments
However, the federal government has several rules and regulations in place to protect participants from unreasonable risks and to make sure that patients are properly informed of the details of a clinical trial before signing up for one.
Some general protective measures U.S. clinical trials follow are:
- Only testing on patients after a treatment is proven safe in laboratory animals
- Requiring a consent form to ensure participants understand key facts about a study
- Requiring several phases of a clinical trial and close monitoring of patients before testing on larger populations
Top mesothelioma cancer centers and other top medical facilities often enforce their own measures on top of federal requirements to further protect participants.
Top medical research centers may take safety measures such as:
- Setting up review boards to review all research proposals
- Regular reviews of clinical trials throughout the research process
- Reviews from specialty committees and colleagues outside the institution
If a new mesothelioma treatment has made it to the clinical trial stage, it means that these therapies are considered reasonably safe and they may improve patient prognosis.
A good result from an experimental treatment is far from guaranteed, however, and patients should speak with their doctor about a particular clinical trial and its potential risks.
How to Find a Mesothelioma Clinical Trial
There are many resources available for finding suitable clinical trials for mesothelioma, but some of the first to turn to are mesothelioma doctors and other medical care team members.
These experienced professionals are often aware of the latest treatments in development for mesothelioma and can make recommendations.
Resources for finding new clinical trials for mesothelioma include:
- Mesothelioma doctors
- Other members of a patient’s medical care team
- The National Cancer Institute (NCI)
- Cancer center websites
Patients may wish to check multiple resources to consider as many options as possible.
For mesothelioma clinical trials found online, patients should check the requirements and current recruitment status (listed clinical trials may be closed to new participants) and then check with their doctor to see if they are able to participate.
Patients can learn more about clinical trials and other treatment options in our free Mesothelioma Justice Guide.
Active Clinical Trials for Mesothelioma
Several mesothelioma clinical trials are currently being conducted in the United States. NCI provides a list of clinical trials for mesothelioma that it supports. Clinicaltrials.gov provides a more extensive database of clinical trials within and outside of the United States.
How to Participate in a Mesothelioma Clinical Trial
Any mesothelioma patient looking to get involved in a clinical trial should work closely with their doctor to determine which trials may be most helpful for them and how to sign up for those trials.
To enroll in a mesothelioma clinical trial, patients may take the following steps:
- Find clinical trials: Patients can work with their doctors to find clinical trials for mesothelioma that they qualify for. Individuals may wish to reach out to another mesothelioma specialist, mesothelioma organizations, or websites to see if they are eligible for additional clinical trials.
- Review trial information: Patients should review clinical trial information with their doctors and families to determine what is best for them and their loved ones. Paying special attention to a clinical trial’s consent form should help the individual know what to expect in terms of treatment, costs, and more.
- Ask questions: Patients should ask their doctors any questions they have about the trials they are considering before making a final decision.
- Choose a trial: Once they are comfortable with their choice, mesothelioma patients can tell their medical team that they wish to enroll in a mesothelioma clinical trial. Their team will guide them through the process of applying.
Anyone interested in joining a clinical trial should speak with their doctor about the active clinical trials they may be eligible to join.
Common screening factors for mesothelioma clinical trials include:
- Stage of mesothelioma
- Type of mesothelioma
- Patient health and medical conditions
- Past treatment history
After determining which clinical trials for mesothelioma a patient is eligible for, it may still be difficult to know which clinical trial to enroll in. However, asking one’s doctor relevant questions is an important part of making a sound choice.
Questions to Ask Your Doctor About Clinical Trials
Mesothelioma doctors are a vital source not just for standard care, but for finding, selecting, and enrolling in mesothelioma clinical trials.
Questions to ask about clinical trials for mesothelioma:
- Do you know of any clinical trials I could join?
- What organization is behind this trial?
- What is the purpose of this trial?
- What tests and treatments does this study involve?
- What does the treatment do?
- Has this treatment been used on mesothelioma patients before?
- Will I know if I receive the new treatment or if I’m part of the control group?
- What are the benefits and the risks of participating in this trial?
- How might this study impact my daily life and current treatment plan?
- Where will I need to go to participate in this study?
- What will this study cost me? Are there any associated expenses I should be aware of, like travel costs?
- What long-term follow-up care does this clinical trial include?
Patients should take advantage of their doctor’s expertise and any and all questions they have regarding mesothelioma clinical trials. This includes clarification on any terms they may not know.
Join a Clinical Trial That’s Right for You
Each clinical trial has eligibility requirements that patients must meet before being accepted into a study.
Patients need to consult a mesothelioma specialist to discuss the risks and benefits of participating in mesothelioma clinical trials. Patients must also consider what trials they qualify for given their mesothelioma location, stage, and cell type.
If you are interested in participating in a mesothelioma clinical trial, contact the Mesothelioma Hope team today to get connected with a mesothelioma specialist who can recommend active clinical trials suitable for you.