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Mesothelioma Clinical Trials

Finding new and effective treatments for pleural mesothelioma can be a long and tedious process because of the scientific precision required to produce a safe treatment. After drugs or therapies are tested in a lab and deemed appropriate for further testing, they are then offered to patients by means of a clinical trial. At this point, patients with mesothelioma become part of the mix because researchers are now convinced that the treatment can truly assist those with the disease.

Clinical trials not only benefit the drug manufacturer or those who have a vested interested in the development of a new medication or treatment, but also the patient who is involved in the trial. While participating in a clinical trial may seem intimidating at first, many patients who participate see positive results and are pleased that they were able to assist in getting a beneficial drug or treatment to the market where it can help other pleural mesothelioma patients.

Pleural Mesothelioma Clinical Trial Phases

The U.S. Food and Drug Administration requires that testing for all new medical treatments or drugs be carried out through three phases of clinical trials before they can be approved for use by the general public.

• Phase I - This phase of a clinical trial focuses on determining correct dosage and relative safety of the drug or treatment in question and employs just a small number of participants. At this point, a drug has already been tested on animals in the laboratory and the researchers are now interested in how humans will react to the drug and what kind of side effects it may cause. Generally, the first participants in a Phase I trial are given a very low dose of medicine to minimize the risk of adverse side effects. Once the low dosage is deemed safe, a later group of patients in the same trial will then be given a larger dosage of the drug.
• Phase II - This longer phase is tested against the particular illness for which it is intended and involves more participants than Phase I. Trial subjects will be given the highest dose that has previously been determined as safe for the patients. During the trial, patients will be carefully monitored and their doctor (or other medical professionals) will study the drug’s or treatment’s effect on the cancer. The patient’s overall health will also be monitored to determine any adverse side effects.
• Phase III - When a drug or treatment for pleural mesothelioma reaches Phase III, it is tested against already existing treatments for pleural mesothelioma. Researchers want to determine, for example, if Drug Y works better than Drug Z in treating the disease. This phase includes the largest number of participants, often times several hundred. Patients in a Phase III trial are commonly divided into two groups, the control group and the experimental group. The control group receives the already approved drug while the experimental group receives the new treatment. These are generally “blind” studies, which means that the patient (and sometimes the doctor) will not know if he or she is receiving the standard or the new treatment.

Throughout all phases of the clinical trial, pleural mesothelioma patients will be carefully monitored by their doctor.  Researchers are required to stop the trial if any of the participants suffers from severe side effects and the study may also be stopped if one group experiences dramatic improvement as compared to the other.

Who Can Participate?

Participation in a pleural mesothelioma clinical trial is voluntary and only a doctor or other medical professional can determine whether or not a particular patient is qualified for the trial. There are always strict guidelines that must be met and not all pleural mesothelioma patients will qualify for all pleural mesothelioma trials.
Patients who participate in clinical trials must be willing to surrender control of their treatment. That means, for example, that in a Phase III blind study, the patient must understand that he/she may receive the old drug, not the new one that offers a more promising prognosis.
It’s important to note that all trials are closely watched to insure the best possible results and that patients will be well-informed of the risks and benefits of the trial before they decide to sign on the dotted line. Once the patient is satisfied that they understand the terms of participation, they will be asked to sign a consent form but may withdraw from the trial at any point if something is making them uncomfortable. Their doctor will supervise the withdrawal.

Ask Questions

The American Cancer Society advises pleural mesothelioma and other cancer patients to ask plenty of questions before they choose to participate in a clinical trial. All the facts and figures should be clear before the patient makes the final decision. You’ll want to know:

• When the trial begins and ends
• How often you’ll need to visit the doctor or hospital during the trial
• The potential side effects of the drug/treatment
• Whether or not it is a blind study
• If you will be expected to undergo additional tests or procedures before, during, or after the trial
• Whether the study will have a bearing on your prognosis
• Whether or not there are better options for your treatment

Many pleural mesothelioma patients who participate in clinical trials note a feeling of satisfaction for their hand in testing new and novel drugs and treatments for their disease. While some will walk away with the same prognosis as before their participation in the trial, others will benefit greatly. Those willing to take the chance often note that they would do it again if, at the least, it will help others in the same predicament.

For additional information about ongoing pleural mesothelioma clinical trials and other treatment options available to pleural mesothelioma patients, please call 1-800-381-1772 to speak with a Patient Advocate or fill out the form on this page to receive an informative packet in the mail.

Sources:

1. http://clinicaltrials.gov/ct2/info/understand
2. http://clinicaltrials.gov/ct2/info/about