Many patients with mesothelioma and their loved ones look to clinical trials to find new and better treatment options while they live with a disease without a cure.
Clinical trials are carefully designed and controlled studies that include humans in the quest to determine whether a treatment or protocol is safe and effective. Most people understand that clinical trials are used to determine if a new drug or medicine is safe and effective, but clinical trials are used for other reasons as well.
When surgeons want to test a new surgical technique or procedure, they do a clinical trial. New treatment protocols (such as whether a combination of chemotherapy drugs
followed by radiation therapy is safe and effective) are tested by a clinical trial. Medical equipment is also tested in clinical trials before being approved.
However, some misconceptions remain about clinical trials, and there are plenty of questions that patients may have, including:
- What are clinical trials all about?
- What do the different phases of clinical trials mean?
- Am I eligible for a clinical trial?
- How do I find clinical trials?
- What do I need to consider when deciding to participate in a clinical trial?
Types and Phases of Clinical Trials
There are many types of clinical trials. When a trial tests whether a particular treatment is safe and more effective than the current standard of care, it is called a treatment clinical trial. If the study is looking at which factors reduce the risk of getting a disease, it is called a prevention clinical trial.
There are screening trials and diagnostic trials aimed at improving the way diseases are detected. Finally, some trials look at ways to better manage symptoms
such as pain, nausea or neuropathy; those trials are called supportive care trials or palliative care trials.
In clinical trials, there are five phases. A Phase 0 clinical trial is the first time that humans are involved in the investigation. Prior to Phase 0, research is carried out on animals or in live tissue samples in a lab. Phase 0 trials usually involve just a few patients who are given micro doses of a particular drug to see if there are adverse reactions. Usually patients in a Phase 0 trial have no treatment options left.
In Phase I trials, there are more subjects — up to about 80 — and the goal is to determine the maximum dose that can be given safely to humans. Researchers also gather data about side effects in Phase I trials.
There are quite a few more subjects — up to a few hundred — in Phase II trials, and the focus remains on investigating the dosing and safety of the drug. If a drug shows promise in its effectiveness, then it will progress to Phase III trial.
A few thousand subjects across multiple locations are involved in Phase III trials. At this point, patients are randomly grouped into a control group or an experimental group. The control group receives the current standard treatment for a particular illness. The experimental group receives the new drug that has shown promise in the previous phases of the clinical trial.
Some treatments undergo Phase IV clinical trials, which are usually carried out after the FDA has approved the treatment and may be sponsored by pharmaceutical companies.
Eligibility for and Participation in Clinical Trials
To maintain the integrity of the study, clinical trials have strict eligibility criteria. A checklist is available online to help determine if you are eligible for a particular clinical trial. Completing the Cancer Details Checklist will help you gather all the information you need to determine your eligibility for a particular clinical trial.
The National Cancer Institute funds many clinical trials for promising new cancer treatments, and it also manages a comprehensive database of all clinical trials in cancer care. You can search for clinical trials
for which you may be eligible, using the information from your completed Cancer Details Checklist.
Once you find a clinical trial that you may want to participate in, there are many questions to ask and things to consider. Good questions to ask your physician or clinical research oncology nurse are:
- What are the benefits of this trial?
- What are the risks?
- Can I stop the trial once I start?
- Who pays for my participation in the trial?
Informed consent is a process that outlines in detail the risks/benefits and particulars of the study. Because informed consent documents can be dozens of pages long and hard to understand, make a note of all of your questions and concerns and ask your physician before you sign the form.
Once your questions have been answered about a clinical trial, it is then time to consider your options, which usually include the current standard of care treatment
vs. participating in a clinical trial. Some mesothelioma patients report that it can be a stressful choice to make, especially when loved ones weigh in with their own opinions and can add further stress.
It is important to have a full understanding of the details of participating in a clinical trial. From there, it is vital to focus on what you, the patient, really want and what you can live with in terms of the choice you make.
The Future of Treatment
Clinical trials are the future of better treatment for mesothelioma, and it is helpful to remember that all of the drugs that have been approved by the FDA have undergone clinical trials. New clinical trials are opening up all the time, so remember to search often for clinical trials during your mesothelioma treatment.
Ask your oncologist about clinical trials, but be prepared to do your own research. Be empowered to ask lots of questions so that you feel comfortable with whatever treatment decision you make.
Questions and Answers from the January Online Support Group
Patients and caregivers asked a number of questions during the recent online support group. Here, we include answers to some of them.
This material was shared in the Jan. 8, 2014, mesothelioma online support group.
Don’t miss the next online support group!
Q: How many mesothelioma clinical trials are there, and how successful are they?
A: The number of mesothelioma clinical trials
has steadily increased over the years, and a few dozen are taking place throughout the United States. Even more trials are underway internationally. Though none of the trials has discovered a cure for mesothelioma, they are making improvements to the effectiveness of mesothelioma treatments.
Q: What detection tools are used to monitor the growth of a mesothelioma tumor?
A: The two most common tools used to detect and monitor mesothelioma tumors are PET and CAT scans
Q: I was told that the chemotherapy drug that worked for me previously won’t work now that I’ve had a recurrence. Is this normal?
A: Yes, this is common. Though one chemotherapy
drug may have an impact initially, it is common for the drug to not work as well if the cancer comes back.
Q: Is it common for mesothelioma patients to need oxygen tanks?
A: Yes, many mesothelioma patients will use oxygen tanks
when breathing becomes difficult. Portable and lightweight tanks are available that make mobility and traveling easier.
Q: I read about a new drug being developed by Novartis that may target mesothelioma cells and not harm healthy cells. Will this drug be available
A: The drug, panobinostat
, is a chemotherapy agent currently in initial phases of laboratory development and has not been tested in animals or mesothelioma patients. Initial results suggest the drug might improve the effects of the chemotherapy drug cisplatin. Further testing in animals is planned to learn more about the drug’s potential.