Newly-diagnosed patients with malignant mesothelioma are forced to face a harsh reality early on in their cancer journey – there is no universally effective treatment for this aggressive cancer.
In fact, as a highly resistant malignancy, mesothelioma is often unresponsive to even the “gold standard” treatment combination of pemetrexed (Alimta) and cisplatin.
But that does not mean that mesothelioma patients do not have options. Clinical trials, the tools scientists use to test promising new mesothelioma treatments, are a good alternative for many patients.
Clinical Trials of New Mesothelioma Treatments
Although there can be a stigma around drug testing on human subjects, the FDA’s rules governing clinical trials today are strict. No drug can be used on a human subject until it has been extensively tested for safety and efficacy, both in the laboratory and in animal subjects.
Patients who participate in a Phase I clinical trial may be among the first to receive a promising new mesothelioma treatment. During Phase I, researchers are looking to determine
- The appropriate dose
- The appropriate treatment schedule
- Whether there are side effects
- How effective the treatment is
Phase I trials are focused on safety, rather than survival. They usually last less than a year and include just a few dozen volunteers.
By the time a potential new mesothelioma treatment has been approved for a Phase II clinical trial, it has been demonstrated to be effective in human patients and the safest effective dose has been established.
Phase II clinical trials for mesothelioma go a step further to show how safe a treatment is and how well it works. They may include groups of patients, each of whom receive different doses of the new treatment. Some participants may receive the standard treatment while others receive both the standard and the new treatment.
Phase II trials typically last for around two years and include up to about 100 mesothelioma patients.
Phase III Mesothelioma Trials Compare New with Old
Phase III clinical trials allow doctors to compare a new mesothelioma treatment that has worked well for Phase II participants against standard mesothelioma therapy.
The goal is to determine if the new treatment is either more effective or produces fewer side effects than the standard treatment. If it does, that new drug may replace the standard of care for mesothelioma. This happened with the drug Alimta in 2004.
To date, Alimta (pemetrexed) remains the only drug specifically approved for the treatment of pleural mesothelioma. However, several new immunotherapy drugs, including pembrolizumab, durvalumab, and tremelimumab, have shown promise in the treatment of mesothelioma in recent years.
Some mesothelioma patients who participated in clinical trials of these drugs have seen marked shrinkage of their mesothelioma tumors and other indications of disease reversal. Trials of these drugs are ongoing.
With a clinical trial, study participants receive the drug at no cost. The trial may also cover other expenses such as travel and tests to monitor the treatment’s effectiveness. Mesothelioma patients can be involved in a clinical trial at any one of the three phases.
Getting Connected to a Mesothelioma Clinical Trials
Because there is risk inherent in using an unproven therapy, the decision whether or not to enroll in a mesothelioma clinical trial is highly personal. Mesothelioma patients should work with their physician and weigh the pros and cons of clinical trial participation.
For a searchable list of current open clinical trials for people with malignant mesothelioma, visit ClinicalTrials.gov.