Most patients who are ultimately diagnosed with mesothelioma do not expect to be cured and to go into remission, which is possible with many other types of cancers. Rather, in many mesothelioma patients, treatments are used to extend the cancer patient’s life and to ease the symptoms associated with malignant mesothelioma.
Many malignant mesothelioma patients will try to participate in clinical trials that are testing new drugs or treatment methods for pleural or peritoneal mesothelioma, especially when traditional treatments that are available have not worked or have not been successful. Sometimes clinical trials can help mesothelioma patients to live longer lives, or to lessen the symptoms associated with their cancer. In other cases, a clinical trial might not result in the benefits that the cancer patient was hoping for. In yet other cases still, a malignant mesothelioma patient might be too sick to participate in any clinical trials due to their performance status, leading the researchers of the clinical study to determine that it is not safe for the patient to participate in the clinical trial of a new drug or treatment. Or, under other circumstances, a mesothelioma patient might not be able to enroll in a clinical trial due to the fact that the study has already been filled, or because the patient has one or more exclusion criteria or does not have the requisite inclusion criteria to be part of the study. Under these types of circumstances, as well as in other situations, a mesothelioma patient may turn to experimental or investigational treatments for mesothelioma. Some experimental or investigational therapies are a final chance to survive for more time, while others may be designed to ease symptoms.
Trying Experimental Drugs through Expanded Access or Compassionate Us
In order to learn more about possible experimental or investigational treatments for mesothelioma that you may be eligible to try, it is important to understand first how you could be able to gain access to these treatments or to these medicines. Typically, Phase I trials of clinical trials—which are the first phase in a clinical trial—are performed on healthy volunteers or participants in order to assess safety. Then, once a particular treatment or medicine has been shown to be safe enough based on participant experiences in Phase I, the treatment or drug can move to Phase II, and later to Phase III, in which patients who have mesothelioma or other types of cancer can be eligible to take these experimental or investigational drugs. However, as you may know, in order to participate in a clinical trial, you will need to meet certain inclusion criteria and will need to show that you do not have specific exclusion criteria. You will also need to be able to pass certain tests or to undergo procedures or scans to prove that you are healthy enough, despite your mesothelioma, to participate in the clinical trial. Much too often, mesothelioma patients are ineligible for certain clinical trials because they are too sick to take part safely in the study.
For individuals who cannot participate in clinical trials but still want to be able to have access to experimental or investigational treatments, the most common way to access these treatments is through expanded access or compassionate use. In effect, as the American Cancer Society explains, once a drug or treatment has progressed sufficiently through the phases of a clinical trial but has not yet received FDA approval, it may be possible for certain patients who have no other options to receive these drugs or treatments outside the setting of a clinical trial. In most situations, compassionate use or expanded access requests are complicated, so it is important to seek help both from your health care team and from an attorney with legal experience advocating for patients who need help gaining access to experimental drugs.
Patients may be able to obtain certain experimental treatments when they are terminally ill through The Right to Try Act from 2018, which is a federal law that allows certain terminally ill patients to obtain certain medications or treatments when they have exhausted every other approved option to extend their life or to ease symptoms associated with mesothelioma or another condition.
In sum, there are three ways in which a mesothelioma patient may be able to gain access to experimental or investigational therapies or treatments:
- 1) Participation in a clinical trial;
- 2) Through expanded access or compassionate use programs; or
- 3) Through The Right to Try Act.
Types of Experimental or Investigational Treatments for Mesothelioma
Now that you have some more information about how people typically obtain access to experimental or investigational medicines or treatments for malignant mesothelioma when they have been unable to participate in a clinical trial, you should learn more about the types of experimental or investigational treatments that may be available. Since clinical trials are constantly taking place, and new clinical trials are being initiated, the list of any experimental or investigational treatments for mesothelioma listed here might already have received FDA approval by the time you begin seeking treatment. In addition, the list presented here might not include new and recent experimental and investigational treatments that have newly become available through expanded access or compassionate use. Accordingly, it is critical to speak with your health care team about your options for treatment, including ways in which you can find out about new experimental drugs and the types of investigational treatments that could be relevant to you and your health.
In the early 2000s, there were several key types of experimental or investigational treatments that included (and may still include):
- Monoclonal antibodies (MoAbs), are molecules that are created in a laboratory so that they will bind to antigens, which are specific protein structures, on the surface of malignant mesothelioma cells. The way in which these therapies work is to block further growth of the mesothelioma cells and the tumor. These therapies can also enlist the body’s immune system, training it to attack malignant mesothelioma cells. Sometimes monoclonal antibodies are used individually, but they are more commonly used in connection with other treatments or drugs designed to fight malignant mesothelioma. Some MoAbs rely on mesothelin, which is a specific kind of protein that exists on epithelial mesothelioma cells and is connected with malignant mesothelioma diagnoses. If you look at the list of current clinical trials for malignant mesothelioma approved or supported by the National Cancer Institute, you will see a number of clinical trials that involve mesothelin.
- Gene therapy is a kind of treatment through which researchers alter your body’s genes so that they can better fight malignant mesothelioma. Gene therapies are used for a wide range of health conditions, including malignant mesothelioma and other types of cancers, as well as other diseases. Gene therapy ultimately may be able to shrink a malignant mesothelioma tumor by tricking malignant mesothelioma cells to die and by improving the body’s ability to fight off those cancer cells and prevent them from reproducing further. Accordingly, gene therapies can, in some cases, reduce the size of an existing cancer in addition to preventing the growth or proliferation of new cancer cells. According to the S. Food and Drug Administration (FDA), gene therapy can be understood quite simply as a “technique that modifies a person’s genes to treat or cure disease.” There are different types of gene therapies, which can include plasmid DNA, viral vectors, bacterial vectors, human gene editing technology, and patient-driven cellular gene therapy products.
- Experimental surgical therapies can range widely from surgical procedures that involve chemotherapy and heat to those that involve the removal of large sections of the area where the mesothelioma is present. Many experimental surgical procedures can be risky, and it is important to talk with a doctor before making the decision to undergo experimental surgical therapy.
Some more commonly cited types of experimental or investigational treatments for malignant mesothelioma used recently include but are not limited to the following:
- Immunotherapies that use the patient’s immune system to fight the mesothelioma, which may include Car T-Cell therapy or checkpoint inhibitors (and many types of immunotherapies have received FDA approval for treating malignant mesothelioma, so you may not need to seek approval for an experimental treatment depending upon your situation);
- Photodynamic therapy that relies on light to kill malignant mesothelioma cells;
- Multimodal therapy is a term that refers to the combination of two or more experimental treatments or therapies to fight malignant mesothelioma, including the SMART Protocol (which includes surgery and radiation), as well as surgical procedures combined with chemotherapy;
- Tumor treating fields (also known as TTFields), rely on electrical currents to stop or slow down the growth of malignant mesothelioma cells;
- Epigenetic therapy, which is in the area of gene therapy and changes the way in which cells currently use their existing DNA;
- Cryotherapy, uses cold gas or fluid to freeze and kill malignant mesothelioma cells; and
- Experimental chemotherapy, such as pressurized intraperitoneal aerosol chemotherapy or sticky chemotherapy.
To determine your eligibility for an experimental drug or treatment, or to seek advice about obtaining one of these drugs or therapies, you should have a discussion with your health care provider.