Mesothelioma Cancer Clinical Trials
Since there is no cure for mesothelioma, medical organizations constantly sponsor numerous clinical trials to test experimental drugs, surgical procedures, chemotherapy, and other unproven potential treatments. Pleural and peritoneal cancer are the two most common forms of mesothelioma, making them the focus of many clinical trials. Before the U.S. Food and Drug Administration approves a treatment for mesothelioma and any other type of disease, it must pass through three clinical trial stages.
Trial Phases
Clinical trials have three phases. Phase I analyzes how safe a treatment is, what side effects it may have, and how much of the drug or other treatment should be administered. There are usually a small number of people involved in these preliminary tests, ranging anywhere from 20 to 80. Phase II attempts to analyze how effective a treatment is, and continues to ascertain its safety. This phase involves significantly more patients, usually recruiting anywhere from 100 to 300.
The final phase aims to validate how effective a treatment is, and precisely what side effects it may have. Additionally, the treatment is compared to others occurring at the time. Phase III trials involve the largest number of people, usually recruiting anywhere from 1,000 to 3,000. In some instances, a Phase IV trial may help collect more data, but this occurs only after the treatment has been approved by the U.S. Food and Drug Administration. Since mesothelioma is a relatively rare disease, there may not be enough patients to achieve the usual testing quotas.
Trial Statuses
Trials may be actively recruiting patients, closed to new patients but still in progress, or completed.
Qualifications
Every clinical trial has different eligibility guidelines. Factors that allow someone to participate in a clinical trial are called inclusion criteria, while exclusion criteria are exactly the opposite--circumstances that prevent a person from taking part. A person's physical health, gender, age, type of cancer, stage of cancer, and treatment history can all play a role in whether he is eligible for a mesothelioma clinical trial. For instance, if a person has other medical conditions, he may be more or less likely to be included. The same methodology applies to people who have been treated for mesothelioma before; depending on the type of treatment and effect it had, they may be more or less eligible for a specific clinical trial.
Recent Clinical Mesothelioma Trials
The National Cancer Institute is doing Phase II testing on the safety and efficacy of a drug called IMC-A12, an antibody that attempts to block cell receptors that respond to a protein which helps cancer cells proliferate. Patients with pleural and/or peritoneal mesothelioma that has not responded to chemotherapy are eligible.
The University Health Network of Toronto is doing Phase II testing on the effects of a drug called Pemetrexed/Alimta paired with Cisplatin before surgical mesothelioma removal, and combined with radiation therapy afterward. Patients with mesothelioma and pleural mesothelioma are eligible.
The Southwest Oncology Group is undertaking Phase I and II testing on the side effects and best dose of a drug called cediranib maleate paired with cisplatin and pemetrexed disodium. Patients with malignant pleural mesothelioma are eligible.
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