Clinical trials are critical for advancing treatments and finding a cure.
Clinical trials each have their own specific set of criteria for eligibility.
Some patients who participated in clinical trials saw greatly improved life expectancies.
Clinical trials aren't a good fit for everyone, so be sure to discuss with your doctor.
Due to the rising number of cases of mesothelioma, the disease has attracted more attention in recent years. More research dollars are being spent to find new drugs and procedures in an attempt to halt the disease or treat its symptoms. These studies have already shown promise in advancing the standard treatment for mesothelioma, which has remained the same for many years.
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. 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.
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. Before the FDA even considers use in humans, the drugs are usually tested on animals to be sure their use carries no serious consequences.
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 trial 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 in question before it is released to the general public. Some drugs will never be approved while others that show great promise may be rushed through the system in hopes of saving more lives.
Patients may benefit greatly from participation in clinical trials but there are risks involved and there is the chance that mesothelioma victims will see no change at all in their condition, even during or after the clinical trial. Anyone thinking of enrolling in these research studies should understand the risks and potential outcome before agreeing to participate and should talk frankly with their doctor about what may be involved. Explore potential side effects (if available), determine the length of the study, and read any written literature carefully before signing any legal or medical papers associated with the trial.
In addition to the treatment and possible side effects, patients should also consider some of the more practical expectations of joining the research study, like the location and if they will have to travel to the cancer center and if health insurance will cover additional costs. Many clinical trials are sponsored by the cancer centers themselves or medical organizations like the National Institutes of Health, which would cover most costs of the new treatment, but patients should be sure to have these details squared away before signing paperwork.
Clinical Trial Eligibility
When considering joining a clinical trial, patients need to keep in mind that they will need to fit the eligibility requirements, as well. Depending on the study, investigators may limit participants based on a number of factors.
- 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.
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:
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 200-300 patients.
Phase III Trials
If a drug has successfully passed through Phases I and II, it is swiftly approaching approval. 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 group can include up to about 3,000 participants, allowing researchers to form a larger database about the new drug. Soon, when the drug is approved, this information will be released to the medical community and general public.
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.
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 Research and 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. Mesothelioma warrior Mavis Nye, for example, was facing more advanced disease and stopped responding to chemotherapy when she was accepted into an immunotherapy clinical trial. After facing a prognosis of just a few months, Nye has been in remission for over a year thanks to the experimental treatment.
Even clinical trials working to improve more 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 continuing tweaking the dosage and combination 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.