Mesothelioma Clinical Trials

Clinical trials for mesothelioma patients primarily focus on pleural and peritoneal mesothelioma, the two most common forms of the cancer. Because a definitive cure has not been established, these clinical trials typically evaluate experimental treatment methods involving chemotherapy drugs, surgery techniques and other emergent procedures. Overall, mesothelioma clinical trials offer a way to test up-and-coming treatments and medications that have not yet been approved for safe and effective use.

Mesothelioma patients often elect to participate in clinical trials to take advantage of cutting-edge treatments such as immunotherapy or gene therapy. Participating in clinical trials does come with some element of risk depending upon the structure of the trial. Discussing this option with your doctor is important to understand all the risks and potential benefits of participating in a clinical trial.

Clinical Trial Phases

Three primary phases help to classify the stages of clinical trials. These separate phases determine when a particular treatment is tested for safety, effectiveness and whether or not it is better than a current approach.

Phase I

Drug's safety & dosage determined

Phase II

Drug effectiveness fortreating target illness determined

Phase III

Drug effectiveness compared against existing treatments

Phase I

trials test a small group of people (typically between 20 and 80 patients) to analyze the safety, correct dosage and side effects of a treatment.

Phase II

trials test a larger group of people (typically between 100 and 300 patients) to analyze the effectiveness of a treatment and further evaluate its overall safety.

Phase III

trials test large groups of people (typically between 1,000 and 3,000 patients) to confirm the effectiveness and side effects of a treatment. The treatment is also compared to current treatment approaches.

If a treatment passes through all three phases, it will likely receive approval by the national regulatory authority (U.S. Food and Drug Administration) for public use. A Phase IV trial may be conducted as a post-approval study to gather any additional information. It is important to note that due to the rarity of mesothelioma cancer, the number of participants at each phase may be much smaller. This is especially true for Phase III trials.

Qualifications for a Mesothelioma Clinical Trial

Each clinical trial has guidelines that determine the eligibility of participants. Doctors and researchers often refer to these guidelines as inclusion and exclusion criteria. Inclusion criteria are the factors that allow a patient to participate. Exclusion criteria are the factors that prevent a patient from entering a clinical trial.

Similar to other trials, the inclusion and exclusion criteria for mesothelioma clinical trials are based on the following:

Age of participant
Gender of participant
Overall physical health of participant
Type and stage of the cancer
Participant’s treatment history

While some clinical trials require mesothelioma patients who have not benefitted from other treatments, others request patients who have not been treated at all. The presence of other medical conditions can also be a part of the inclusion or exclusion criteria.

Recently Completed Clinical Trial

In a recently completed Phase II mesothelioma clinical trial, titled “Phase II Trial of Neoadjuvant Alimta Plus Cisplatin Followed by Surgery and Radiation in the Treatment of Pleural Mesothelioma,” researchers evaluated the multimodality approach of chemotherapy, surgery and radiation therapy. The trial was conducted between 2005 and 2011 and involved 54 patients.

Of the 54 patients enrolled, 22 completed the trial. The 32 patients who did not complete the trial either experienced an adverse event (1), death (11), lack of efficacy (16), protocol violation (2), physician decision (1) or withdrew from the trial (1). The participants received the chemotherapy drugs pemetrexed (Alimta) and cisplatin for three 21-day cycles followed by surgery (extrapleural pneumonectomy) and radiation therapy. The average time to disease progression after treatment was 14.4 months. The average overall survival was 15.5 months.

These results present a slight extension of life expectancy, which averages around one year for mesothelioma patients, but can range from four to 18 months depending upon the stage at diagnosis.

Clinical Trial Resources

Mesothelioma patients looking for more information on clinical trials can now browse the following pages that list recruiting, not recruiting and completed trials. Understanding the qualifications and treatments of these trials can be difficult for those not familiar with medical terms.

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