Clinical Trials at the Children's Center for Cancer and Blood Diseases

Many treatments used today are the results of clinical trials conducted in the past.

A clinical trial is a research study conducted in human beings. Clinical trials are conducted with the ultimate goal of finding treatments that are more effective in a particular disease. Each clinical trial has different goals. Some of these goals include improving survival rates; study a new drug or a reduction in side effects and long-term effects of treatment. Not every clinical trial is appropriate for every patient. Your doctor will advise you of any appropriate clinical trials available for your child. In order to qualify for a clinical trial, your child will need to meet certain requirements, which are listed in each clinical trial.

Types of clinical trials

Three different phases of medical studies called clinical trials are usually used to evaluate new treatments for childhood cancers, as well as other diseases. Each phase has a different goal.

• Phase I studies are the most basic of clinical trials. Here, drugs are tested to evaluate the dosages of the treatment, and how often the treatment can be administered (maximum tolerated dosages, MTD). As it is unknown whether the treatment will be effective against a particular disease, people with a variety of diseases are enrolled. Drugs are given at gradually increasing dosages until there are unacceptable side effects (dose-limited toxicities, DLT).
• Phase II studies use the results from Phase I studies regarding MTD and DLT. The treatment is targeted at the population of patients that responded most favorably in Phase I trials, because it is believed to hold promise for that particular group of patients.
• Phase III studies are those that most children will participate on when newly diagnosed. These studies will test the standard treatment (current best) against promising alternatives that may lead to increase cure rates or decrease side effects or long-term effects of treatment.

Benefits of Participation

You may be asking "How does my child benefit from taking part in a clinical trial"?

In a clinical trial, your child receives the most up-to-date treatment. Just as your child benefits from what has been learned from past clinical trials, children with cancer in the future will be helped by what is learned from clinical trials today.