Phase 0 mesothelioma clinical trials are designed to determine if and how a new mesothelioma drug might work in a human. Mesothelioma patients are currently not eligible to enroll in phase 0 studies, but they may be in the near future.
Phase I studies are typically the first time a new drug will be tested in people. Treatments for patients involved in phase I studies are aggressive, as the goal of the study is to determine the highest dose that can be tolerated without causing serious side effects. It is not technically a goal of a phase I study to determine how well the new drug works against the cancer. Phase I clinical trials for mesothelioma are usually a high safety risk to patients and offer a low chance of helping patients. If the drug is found to be reasonably safe in phase I studies, it will advance to phase II studies.
Between 25 and 100 patients might be enrolled in a phase II study, which is a larger group than that in phase I. The goal of the phase II study is to determine if the drug is effective in fighting the cancer. Researchers look for benefits patients may be experiencing such as increased comfort and quality of life, living longer than expected, shrinking the tumors or preventing the growth of the tumors. If enough people benefit from the treatment, and the side effects aren’t too bad, the treatment is allowed to go on to a phase III clinical trial.