Every day, researchers and pharmaceutical companies are striving to develop better treatments and medications for a range of medical conditions—and mesothelioma is no exception.
Before a new drug or procedure can be approved by the U.S. Food and Drug Administration (FDA) and introduced to the general patient population, a clinical trial must be conducted to test it. These trials, which are often the last stage of an extensive research process, are only done when a treatment shows true promise for improved care.
“With mesothelioma, there are numerous factors involved with treatment, and it can be difficult to know what works and what doesn’t,” says Dr. Tom Treasure, thoracic surgeon and researcher at the University College London. “We need multicenter clinical trials that are impartially conducted, monitored and analyzed.”
Clinical Trial Basics
Nearly all clinical trials involve 3 phases of research and testing. The phases help to show if a treatment’s early promise can be maintained over time, while also assisting researchers in spotting side effects and determining medication levels.
Here is a basic overview of the 3 phases:
- Phase 1: This is when a treatment goes from being tested on animals or in a laboratory setting to being conducted on people. The purpose is to determine how much of the medication can be given safely, or whether multiple treatments can be combined together.
- Phase 2: Once a treatment has been tested for safety, patients are observed over time to see how well the treatment works. During this phase, for example, tumor growth or long-term side effects may be noted.
- Phase 3: The last stage of clinical trials, this phase requires large numbers of patients so that treatments can be compared with more data. For instance, including thousands of people instead of hundreds might show certain treatments work better for men than women. Or it may be revealed that treatment effectiveness is improved with different types of medications.
No matter what the clinical trial phase, a participant can always opt to leave the trial at any time. The trials are based on volunteer participation, and a certain number of “drop-outs” are expected due to unforeseen side effects or other circumstances.
Every trial has its risks. After all, these are unproven treatments, and a goal of any trial is to determine whether a treatment has negative side effects. But people often choose to participate for both their own health and the potential impact on others.
“When I signed up, I realized that the treatment might not work for me personally, but that it was important, because what if my participation helps someone in the future?” says Elizabeth Stevenson, who is in a phase 1 cancer trial involving a test of new medication combinations. “Without research, we’ll never get closer to better treatments, and someday, an actual cure for cancer. I feel like I’m doing my part to help.”
Participating in Clinical Trials
According to the National Cancer Institute, malignant mesothelioma is a disease caused by asbestos in which cancer cells can appear in the thin layer of tissue covering the lungs or the tissue lining the abdomen. The condition can also affect the heart, though this is rarer.
Treatment for mesothelioma is individualized and may involve surgery, radiation, chemotherapy and/or other medication. But if those treatments aren’t successful, or the results aren’t as positive as you hoped, you might want to consider a clinical trial to see if a newer therapy works better.
To participate in a trial, the first step is to talk with your physician or oncologist about what trials might be available and whether you may be an appropriate candidate. Many trials have very specific restrictions, which means that your willingness alone isn’t enough to be included.
For example, a clinical trial testing new drug therapies may not be open to mesothelioma patients who are currently on other medications or have already had a treatment like radiation or chemotherapy.
It’s also important to do research on your own, advises Dr. Treasure. “Sometimes, surgeons in particular are resistant to putting their treatments to the test for a variety of reasons, including professional pride and resistance to change,” he says. “But trials are necessary with a disease as variable as mesothelioma, given the number of many possible but untested treatments.”
Finding Clinical Trials
A good first step in finding clinical trials is to check out ClinicalTrials.gov, which provides a registry of federally and privately sponsored clinical trials, both in the U.S. and 173 other countries. Developed by the National Institutes of Health and the FDA, the site collects details on each trial, including how many participants are included, where research is conducted, and contact information for lead researchers.
A recent search with “mesothelioma” as a keyword brought up 271 studies, with 98 of those now doing active recruiting or future recruiting for participants. Each trial listing has criteria that can help you decide whether you might qualify. For example, some trials are looking for patients whose mesothelioma is at a certain stage or who have just been diagnosed, rather than experiencing a recurrence.
The site also features an extensive amount of information about participating in clinical trials, including important questions to ask during the recruitment process. It’s important to be as informed as possible about what’s being studied, what treatments you’ll be receiving, potential side effects, the timeframe of the study and other factors.
Also, check with your health insurance provider to make sure you won’t incur any non-covered costs as a result of participating in a study. Some clinical trials provide treatments without charge to patients, but others don’t. In general, get as much information as you can before the trial begins.
A Changing Landscape
Even if you or your oncologist can’t find a clinical trial that would be right for your situation, you may still be able to participate in the future.
Liz Darlison, a nurse consultant for Mesothelioma UK, says that even though her organization updates ongoing mesothelioma trials and publishes a quarterly report, it’s still sometimes difficult to track all the trials in progress.
“The trials landscape is changing almost faster than we can keep pace,” she says, adding that phase 1 studies — which tend to target particular cancer cell mutations — are the most numerous. She believes those are also the kind of trials that might be best for mesothelioma patients overall.
“There are so few standard options in terms of treatment for mesothelioma, so phase 1 studies offer a genuine option for patients,” says Darlison.
If you or a loved one is suffering from mesothelioma and want to find out more about clinical trials, talk to your doctor or visit ClinicalTrials.gov for research updates and other information.