Cancer

Phase III studies compare the new treatment to a standard (current, state-of-the-art) treatment. At the beginning of the study, doctors don't know if the new treatment is better than the standard treatment. Phase III trials typically enroll hundreds to thousands of patients, and are carried out in treatment centers nationwide. If a drug successfully completes the Phase III level of testing, the pharmaceutical company that makes it can apply for FDA approval for this use.

Phase II studies investigate whether the new treatment works for a specific type of cancer. They also continue to evaluate the safety of the treatment. It is important to realize that it is not yet known whether the treatment will be effective against your cancer. Phase II studies generally enroll no more than 100 people.

Phase I Studies primarily evaluate:

• How much of a new drug can be given safely
  
• How often the drug needs to be given
  
• What the side effects of the new drug are
  

• Medications used in pediatric cancer clinical trials have usually been tested in adult trials before they are used in children. However, because you/your child might be one of the first pediatric patients in the world to receive the new drug, the side effects in children may not be known.
  
• Although this drug has shown promise in the laboratory, in animals, or adults, it is not known if it will work against your cancer.