In patients with stage IV disease that has failed to respond to treatment, the average survival is seven to nine months. As a result, the patients immune system is now able to recognize and attack the melanoma. These trials are open at multiple centers across the United States. Dacarbazine is the only chemotherapeutic agent currently approved by the FDA for the treatment of metastatic melanoma. To obtain this approval, a sponsor must complete a clinical trial that demonstrates safety, efficacy, and potency of the pharmaceutical product.
Clinical trials are the means by which experimental drugs or treatments are tested in humans.
Clinical trials are normally done in three phases. Phase II trials may involve anywhere from 20 to 100 patients. If the treatment works well enough in phase II trials, it is then tested in a phase III trial. It is the result of these large phase III trials that are required by the FDA for drug approval.