Clinical trials are what make progress possible. They fuel the engine of hope. By participating in a mesothelioma clinical trial, you give yourself a chance to receive the best treatment available. You also help future patients by providing valuable information and feedback.
Mesothelioma Clinical Trial Facts:
Clinical trials are a safe, structured way to test experimental treatments.
Many mesothelioma trials are of drugs already approved for other cancers.
Dozens of clinical trials are actively recruiting mesothelioma patients.
Each clinical trial has different criteria for who is eligible to enroll.
What Is a Clinical Trial?
Clinical trials are research studies that involve people. A clinical trial is a controlled way to test whether a new therapy approach is safe, effective and better than existing therapies. When scientists suspect a new therapy will help patients live longer and better lives, clinical trials give them a way to prove it.
These trials are sponsored by government agencies, cancer centers, pharmaceutical companies or a partnership of several organizations. Regardless of sponsorship, every clinical trial is subject to strict regulations and industry guidelines. These guidelines protect patients and ensure high-quality research data.
A clinical trial can last for weeks, months or years, depending on the trial’s goal, the number of patients involved and the results. Most drugs have to pass through multiple phases of trials before being approved by the FDA.
Claire Verschraegen M.D. Director of Hematology/Oncology, University of Vermont Medical Center
“When we talk about being in a clinical trial, the first reaction sometimes from a patient is, ‘You want me to be a guinea pig?’ And I say no, I want you to be a hero. A hero is someone who puts his life out there to help others, someone who really gives of himself. If we keep using the same treatments, we’ll never find a better one.”
Why Should I Participate?
There is no cure for mesothelioma. Doctors are researching new therapies to improve survival rates and quality of life.
A clinical trial may result in an incremental improvement in patient outcomes. Or it may return a negative result that convinces doctors to try different ideas. Sometimes a trial leads to a breakthrough that changes the way doctors approach cancer treatment.
For example, successful trials of immunotherapy are driving one of the biggest shifts in cancer treatment in decades. The U.S. Food and Drug Administration (FDA) has not yet approved immunotherapy for mesothelioma patients. But, many of the latest drugs are being offered to mesothelioma patients through clinical trials.
The stories of participants with mesothelioma attest to the life-changing potential of clinical trials. These stories also reveal the obstacles some patients face.
How Do I Enroll in a Clinical Trial?
The U.S. National Institutes of Health (NIH) maintains a database of past and present clinical trials. A mesothelioma specialist at a cancer center can also help you access new treatments. Talk to your doctor about whether a clinical trial is right for you.
A comprehensive listing of clinical trials for mesothelioma can be found at Clinicaltrials.gov.
Every clinical trial has specific criteria for who is eligible to participate. Some trials are only for patients who have not been treated before. Other trials are exclusively for patients who did not respond well to standard treatments.
Mesothelioma Biopsy Factors
- Age and gender of patient
- Overall health of patient
- Type and stage of mesothelioma
- Patient’s past treatment history
- Underlying medical conditions
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Clinical Trials Recruiting Mesothelioma Patients
Mesothelioma is a rare disease. Around 2,000 to 3,000 patients are diagnosed annually in the United States. It is important for as many mesothelioma patients as possible to participate in clinical trials. Dozens of trials are recruiting mesothelioma patients. A few of the most notable ones are reviewed below.
Keytruda and CRS-207
In the summer of 2017, six cancer centers began recruiting patients for a phase II clinical trial involving a combination of two immunotherapy drugs: Pembrolizumab and CRS-207. Both drugs have already shown promising results individually in previous clinical trials.
Pembrolizumab, marketed as Keytruda, is a well-known immunotherapy agent. It is already approved by the FDA to treat several types of cancer. CRS-207 uses genetically engineered Listeria bacteria to trigger an immune response.
To qualify for this trial, patients must already have received chemotherapy. The trial is expected to run through 2019.
Raffit Hassan, M.D. Senior investigator at the NCI
“Participation of patients with mesothelioma in clinical trials is essential if we are going to make progress and develop novel therapies.”
Nivolumab and Ipilimumab
On the heels of a promising 2016 clinical trial in France, 17 cancer centers around the world are now conducting a phase III clinical trial. The trial is testing whether an immunotherapy drug combination produces better results than standard chemotherapy for inoperable pleural mesothelioma.
The drugs nivolumab (Opdivo) and ipilimumab (Yervoy) have already impressed researchers as second-line and third-line treatment options. Now hundreds of patients will have a chance to receive the immunotherapy regimen as a first-line treatment.
Newly diagnosed patients with inoperable disease are encouraged to participate in the trial. It is expected to last until 2021.
In 2017, a dozen cancer centers across the country began participating in a phase II clinical trial. The trial involves durvalumab, a promising immunotherapy drug. It is already FDA-approved for the treatment of bladder cancer and lauded for its effectiveness in lung cancer clinical trials.
Durvalumab activates an immune system response against tumor cells. It targets cells that overexpress the PD-L1 protein. This protein is common in several cancers.
This is the first time researchers are testing a combination of durvalumab and standard chemotherapy as a first-line treatment for inoperable mesothelioma. To qualify for this trial, patients must not have received any other type of treatment.
Following positive clinical trial results presented in 2016, several cancer centers are now testing the immunotherapy drug anetumab ravtansine as part of a first-line mesothelioma treatment regimen.
Anetumab ravtansine targets mesothelin. Mesothelin is a tumor surface protein found in 85-90 percent of mesothelioma cancer patients. The new phase I trial will combine the novel drug with cisplatin and pemetrexed. These are the most common chemotherapy drugs used for mesothelioma.
The trial is expected to last a year.
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What Risks Are Involved?
Clinical trials always come with certain risks. The experimental treatment may not be as effective as anticipated. You could experience unexpected side effects that harm your health.
To make the process as safe as possible for patients, the FDA structures clinical trials into four phases.
A phase I trial involves the smallest number of people, perhaps only a few dozen participants. It focuses on making sure the experimental therapy is safe. The goals are to analyze side effects, examine how the drug or procedure is processed by the body, and determine safe dosage levels.
A phase II trial takes a closer look at how effective the new treatment is, while still calibrating the safety levels of the therapy. The trial population may include up to a few hundred patients.
A phase III trial involves the largest number of people, sometimes thousands of patients. It measures the effectiveness of the new treatment versus the standard treatment approach. It also is used to finalize dosage amounts and document side effects.
After a drug clears the first three phases of clinical trials, a drug developer can file an application to market the new drug. Even after the FDA has approved a new therapy, further phase IV trials may be required. This phase ensures effectiveness after approval for commercial use for specific indications.
Could I Get a Placebo?
Placebos are not common in cancer clinical trials. Not all clinical trial participants actually receive the new treatments being tested, but all cancer patients participating in a clinical trial do receive excellent medical care. You will not miss out on high-quality medical care by participating in a clinical trial.
Many medical experiments divide participants into a test group and a control group. The test group receives the experimental treatment, while the control group does not.
In a clinical trial involving healthy patients, the control group might receive a fake version of the treatment, which is called a placebo.
In a trial for cancer patients, however, the control group will receive the standard cancer treatment appropriate for them.
Researchers are never allowed to intentionally withhold necessary medical care.
Who Pays for Clinical Trials?
Patients cover standard-of-care expenses. Government agencies or pharmaceutical companies typically absorb the majority of the costs involving the experimental drug.
Government and Industry Funding
The 2017 budget for the NCI was about $5.3 billion, with many millions of dollars set aside for clinical trials of cancer treatments. In recent years, private industry funding has begun to dwarf direct government investment. Hospitals, universities and other research organizations also play a major role.
In the summer of 2017, there were 80 mesothelioma-related clinical trials listed on the NIH database. They can be divided into four categories based on funding source on the website.
Private donations may also help cover the cost of a mesothelioma clinical trial. For example, the University of Hawaii Cancer Center received a $3.58 million gift from an anonymous donor for mesothelioma research in 2011.
Costs for clinical trial participants may include transportation, doctor visits, hospital stays, laboratory tests, X-rays and scans.
Many of these expenses are often covered by health insurance, depending on the patient’s policy. Some states have laws or special agreements that require health insurance companies to pay for routine care received in a clinical trial. For patients over the age of 65, Medicare covers routine costs related to all government-sponsored phase II and III clinical trials.
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Be sure to speak with the sponsor of the clinical trial to understand what costs they cover. Consult with your health insurance company to determine what they will cover.
Factors that determine if insurance companies will pay for clinical trial costs include:
- The phase of the trial
- The duration of the study
- The risks involved with the trial
In many cases, transportation costs present a large obstacle. You may have to travel to a cancer center in another state and arrange for room and board while you are there. Cancer centers and charitable organizations offer grants to help with these expenses.
Questions to Ask Your Doctor
Prior to enrolling, it is important for a mesothelioma patient to fully understand the details and purpose of the trial.
For example, patients should ask the trial sponsors about the specific goal of the clinical trial. Also ask about other treatment options available, costs and possible side effects.
View & Print These Questions to Ask About Clinical Trials
We’ve created a handy list of questions you can print and take with you. Getting answers to these concerns will help you decide if you should participate in a clinical trial.
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Last Modified September 25, 2018
5 Cited Article Sources
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Retrieved from: https://clinicaltrials.gov/ct2/about-studies/learn
Harvard Health Publishing. (2017, May). The power of the placebo effect.
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Martin, L. et al. (2017). How much do clinical trials cost?
Retrieved from: https://www.nature.com/articles/nrd.2017.70
National Institutes of Health. (2017, May). Clinical Trials: Benefits, Risks, and Safety.
Retrieved from: https://www.nia.nih.gov/health/clinical-trials-benefits-risks-and-safety
- National Institutes of Health. (n.d.). Finding a Clinical Trial. Retrieved from: https://www.nih.gov/health-information/nih-clinical-research-trials-you/finding-clinical-trial