Clinical trials are developed in a series of steps, called phases. Clinical trials have three phases:
Phase III Trials
Phase III trials are typically the initial trials offered to newly diagnosed patients. They usually involve a relatively large number of patients and are most commonly conducted at many different hospitals and clinics around the country.
In this phase, the new treatment is often compared to a standard treatment. Your child may be randomly assigned to either the new treatment or the current standard treatment. Doctors monitor to see if the new treatment is better than the standard treatment.
You and your child will know which type of treatment your child is given.
Phase II Trials
Phase II trials are typically offered to patients with a disease that has returned, failed to respond or that has a very poor response to initial treatment.
Phase II trials usually seek to determine how effective the optimal dose of a new drug is against a variety of tumors. These trials usually involve between 30 and 100 patients. Doctors can learn more about the effectiveness, side effects and safety of the particular treatment.
Phase I Trials
Phase I trials represent the cutting edge of innovative cancer treatment and are usually intended for patients with a disease that has returned or failed to respond and for which there is no other known effective treatment.
Phase I trials seek to determine the maximum dose of a drug that can be safely tolerated by patients and how the body breaks down a new drug.
Clinical response is not the main focus of a Phase I trial and less than 10 percent of patients are expected to respond in a Phase I trial. Phase I trials usually involve 10 to 30 patients who are placed in groups of three and closely monitored for side effects.
If your child is part of a Phase I trial, he probably has not responded to standard treatments. The benefit is that your child may be among the first to receive a new treatment.