Medical researchers are constantly seeking a cure for mesothelioma and more innovative, effective treatments. To do this, they conduct clinical trials where patients undergo experimental procedures or try new drugs, and the researchers then analyze the results. The benefit of participating in mesothelioma clinical trials is that patients often get access to advanced treatments or designer drugs. Some of these treatments may even be very promising as a cure for mesothelioma or can significantly prolong survival rates.

However, there are also many risks associated with clinical trials – particularly because the safety or side effects of the treatment may be largely unknown. In addition, some of the trials us a control group that gets a placebo. In that case the patient is receiving no treatment for the duration of the clinical trial. It is very important that patients fully discuss all the benefits and downsides of participating in a clinical trial before they sign up.

Phases of Clinical Trials

Before any treatment gets approved by the FDA, it must go through several phases of clinical trials to prove its effectiveness and safety.  Knowing what phase a mesothelioma clinical trial is in will give you some idea of the treatment’s potential and risks.

• Phase I: During Phase I clinical trials, a new treatment is tested among a small group of patients.  There are usually just about 20-80 patients in a Phase I clinical trial.  Before a treatment can reach Phase I, it must be thoroughly tested in a lab setting and on animals.  However, there is no guarantee that the treatment will be safe in people.  The goal of a Phase I mesothelioma clinical trial is to determine the safe dosage and administration of a treatment.
• Phase II: Whereas Phase I clinical trials for mesothelioma focus on safety, Phase II clinical trials focus on efficacy.  Participants will have their condition monitored very carefully for how it reacts to the treatment.  They will also be monitored for side effects.  Phase II clinical trials are larger with about 100-300 participants.
• Phase III: When a treatment shows promise in Phase II, it can be taken to Phase III clinical trials.  The goal of Phase III clinical trials is to confirm treatment efficacy and side effects.  Phase III clinical trials will consist of many participants – several thousand in some cases.  In Phase III clinical trials, the treatment in question will also be compared to other treatments currently available.

If a treatment makes it through all three phases of clinical trials, it will likely be approved by the FDA.  In some cases, a treatment may have a Phase IV clinical trial where more information is gathered about the treatment after approval. The FDA regulates all clinical trials  Note that the clinical trials for mesothelioma often have fewer participants than other types of clinical trials because the disease is so rare.

A good example of a treatment procedure that has been in tested in clinical trials is the use of pemetrexed in combination with cisplatin. This now approved treatment procedure showed superior survival  rates during the phase III trials. Other treatment modalities tested in trials that have increased mesothelioma survival rates include using novel forms of radiation therapy with surgical cytoreduction and high does intensity modulated radiotherapy combined with extrapleural pneumonectomy. Clinical trials are testing a number of experimental treatments in the area of gene therapy.¹

Who is Eligible for Mesothelioma Clinical Trials?

Each clinical trial for mesothelioma has its own specific eligibility requirements.  Eligibility factors may consist of age, gender, type of mesothelioma, stage of mesothelioma, and whether or not the patient has already received treatments.  Almost all clinical trials for mesothelioma are for pleura or peritoneal mesothelioma because other forms of the disease are very rare.

In the past, mesothelioma tumors and malignant pleural effusion were not always studied separately from the study of other tumors. This slowed down the development of treatments that could effectively help mesothelioma victims and partially explains why survival rates have not greatly improved over the past few decades. Now there are ongoing clinical trials that focus solely on mesothelioma treatments and that is bound to accelerate the discovery of new and successful treatments for this terrible disease. The more researchers expanding tissue banks and publishing clinical trial results, the sooner mesothelioma patients will get relief.²

The National Cancer Institute offers a search feature for clinical trials on its website. You can request the list by entering mesothelioma as the condition and your zip code. This search will net you the closest clinical trial being conducted. Clinical trials play a critical role in the development of successful cancer treatments. You can contribute to the effort through participation.

References

¹ Sterman, D. H. and Albelda, S. M. (2005), Advances in the diagnosis, evaluation, and management of malignant pleural mesothelioma. Respirology, 10: 266–283. doi: 10.1111/j.1440-1843.2005.00714.x

² Stathopoulos, G. T. (2011), Translational advances in pleural malignancies. Respirology, 16: 53–63. doi: 10.1111/j.1440-1843.2010.01890.x

³  Search for Clinical Trials. Retrieved from the National Cancer Institute at: http://www.cancer.gov/clinicaltrials/search