Clinical Trials

Clinical trials are studies to find new treatments and diagnostic tools or improve current methods. They may offer the best hope for extending survival for some mesothelioma patients.

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Key Points

1
Clinical trials are critical for advancing treatments and finding a cure.
2
Clinical trials each have their own specific set of criteria for eligibility.
3
Some patients who participated in clinical trials saw greatly improved life expectancies.
4
Clinical trials aren't a good fit for everyone, so be sure to discuss with your doctor.

Each year, research scientists dedicated to finding a cure and more successful mesothelioma treatment options come up with new possibilities for addressing the disease and they need the help of volunteers to test their finds. These studies have already shown promise in advancing the standard treatment for mesothelioma, which has remained the same for many years. For some patients whose cancer doesn’t respond well to traditional treatments like standard chemotherapy, these mesothelioma research studies may offer the best opportunity for extended survival.

Current Mesothelioma Clinical Trials

Because of malignant mesothelioma’s rarity, the number of mesothelioma patients participating in clinical trials is small. For a list of clinical trials supported by the National Cancer Institute (NCI), click here. Or, use the tool below to find clinical trials within your area. Be sure to consult with your doctor about whether a clinical trial for mesothelioma treatment is right for you and to find out if you qualify.

The Clinical Trial Process

Once the drug is approved for clinical trials involving humans, study directors begin a search for patients who are willing to volunteer to test the new drug. By conducting clinical trials, doctors or researchers hope to discern proper dosages, potential side effects and effectiveness of the drug before it is released to the general public. Sometimes, the process that takes a new drug from infancy to approval by the Food and Drug Administration (FDA) can be quite a long one. Some drugs will never be approved, while others that show great promise may be rushed through the system in hopes of saving more lives.

For some patients, finding a clinical trial to join in the face of a dire prognosis can feel like finding a gold mine. For others, it can be a more difficult decision to make. There are many things to keep in mind when considering joining a clinical trial.

Clinical Trial Eligibility

When considering joining a clinical trial, patients need to keep in mind that they will need to fit the eligibility requirements. Depending on the study, investigators may limit participants based on a number of factors.

Eligibility Criteria

Type of cancer (malignant pleural mesothelioma, peritoneal mesothelioma, pericardial mesothelioma)
Stage of cancer
Cancer treatment history (ie. if a patient has already undergone surgery, chemotherapy or radiation therapy)
Patient’s age, gender and overall health

These are just a few typical requirements mesothelioma trials tend to keep in mind when choosing participants, but keep in mind there may be additional criteria new patients will have to meet.

Understanding Side Effects of New Treatments

When considering joining a trial, the most important part of the process is the patient’s informed consent. Patients will receive a consent form prior to the trial’s start, which will include information from the master protocol, the detailed plan for how the clinical trial will be conducted and its intended purpose. Additionally, the informed consent form will detail the possible risks and benefits the participants should expect.

In some cases, patients may experience less side effects than they would undergoing more conventional treatments. But some may face more or worse side effects than they otherwise would. While the researchers will lay out some of the potential side effects in the informed consent process, they will not always be aware of all the potential risks ahead of time. Since each cancer case is unique, it can also be difficult to determine just how an individual will react to a certain cancer drug.

Patients should note that informed consent doesn’t end at the start of the trial. Throughout the process, patients may need to sign updated consent forms as new side effects or potential risks may arise. Without giving consent to any new dangers, patients will not be able to continue in the trial. But it should also be noted that patients are free to leave a clinical trial at any time before or during the study for any reason.

Costs of Additional Tests and Procedures

When considering joining a clinical trial, another important aspect to consider is the cost of participation. Typically, patients have to undergo more tests and scans to understand how their body is reacting to this new treatment. This could entail more doctor’s visits, and in some cases may even require periods of hospitalization.

Most health insurance plans will not cover the additional care required from a clinical trial. Health insurance will cover routine patient care costs, like treatment for side effects and imaging work, in certain situations.

Factors Determining Clinical Trial Coverage by Health Insurance

The patient is eligible for the particular clinical trial;
The trial is federally approved and funded;
Researchers have submitted an application for FDA approval of the drug; and
The trial only involves in-network hospitals and doctors.

Any research associated costs, like extra doctor’s visits or lab work, will often not be covered by insurance because it goes beyond the scope of standard treatment costs. In some cases, however, these additional costs may be funded by the sponsor of the trial.

Patients should also consider any secondary costs, like travel and lodging for the clinical trial if it’s located far from home.

Clinical Trial Guidelines and Phases

Understanding the hierarchy or phases of clinical trials may help you make an informed decision when considering joining a clinical trial. Currently, the FDA guidelines for clinical trials are as follows:

Clinical Trial Phases

Phase I Trials

Phase I clinical trials are generally quite small since researchers do not yet know the exact affect a drug may have on the human population. They usually involve approximately 20 to 50 patients from a very select group. Goals of this phase include the evaluation of the safety of the drug, dosage range, and potential side effects.

Phase II Trials

Once the Phase I trial has significantly established the safety of the new drug, it’s time to test it on a larger group of patients. This phase determines how effective the drug is against a particular disease or group of diseases. Safety continues to be evaluated. Phase II study groups normally involve around 200 to 300 patients.

Phase III Trials

Phase III clinical trials usually compare the new drug to an established drug that has proven to be effective in the treatment of a particular disease or group of diseases. Once again, effectiveness and side effects will be monitored. A Phase III study can include up to about 3,000 participants, allowing researchers to form a larger database.

Phase IV Trials

These trials are post-marketing tests done after the drug is approved to determine how it might work against other diseases and how to best use the drug. Phase IV clinical trials also ensure the drug continues to work as expected and there are no adverse effects moving forward.

Clinical trials test more than just new drugs. Each day, strides are being made in other areas that might benefit mesothelioma patients, such as new curative and palliative procedures, screening and diagnostic techniques, and prevention methods. These must be tested as well before they can be used by the human population.

The Potential of Mesothelioma Clinical Trials

Over the years, mesothelioma specialists and researchers have discovered many promising new treatments, like immunotherapy, and new diagnostic methods that have the potential to greatly improve prognosis for some patients.

Immunotherapy drugs like Keytruda (pembrolizumab) and Opdivo (nivolumab), for instance, are a promising emerging treatment that work by activating an immune response in the body to better attack the tumor cells. Some of these clinical trials testing these drugs alone and in combination with other treatments have been able to extend survival for mesothelioma cancer patients even years beyond their best prognosis.

Even clinical trials working to improve standard treatments have given patients hope. Alimta (pemetrexed) is the only FDA approved chemotherapy treatment for mesothelioma and has been the standard of care for years. Researchers have worked on tweaking the dosage and combinations of the treatment, with one clinical trial extending life expectancy from 12 months to 16 months. Though it may not seem like a long time period, it is a considerable success considering how difficult mesothelioma can be to treat.

Clinical trials can provide even late-stage patients hope, and should be considered by eligible patients when determining the best treatment plan for improving prognosis.

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