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 0 studies for mesothelioma often use only a few small doses of the new drug in each patient. Researchers test whether the drug reaches the tumors, how the drug behaves in the body and how the cancer cells respond. Due to the very low doses of drug in phase 0 studies, there is low risk to mesothelioma patients compared to other phases. However, there's likewise virtually no potential benefit to a patient enrolled in a phase 0 study. With the requirement of having extra biopsies, scans and blood samples taken, enrolling in a phase 0 study is not usually worth a patient's time and effort.
Then why conduct phase 0 studies at all? Phase 0 studies help researchers determine whether drugs will do what they're expected to do in a human body based on studies in the laboratory. Testing conservatively this way with phase 0 studies will usually bring any potential problems to light quickly. Phase 0 studies aren't included in clinical trials for every drug and when they are used, they're very small, usually with less than 20 subjects.
Phase I Clinical Trials for Mesothelioma
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.
Phase II Clinical Trials for Mesothelioma
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.
The third and final part of this clinical trials overview blog series will focus on phases III and IV clinical trials.