The Center for Cancer and Blood Disorders

When a child is faced with a cancer or blood disorder diagnosis, they need to have access to the most current and effective treatment options possible. In the realm of cancer treatment, that means having access to a wide array of clinical trials.

Research shows that children who participate in clinical trials have better survival rates than those who do not. That’s why our team offers access to more than 300 clinical trials and maintains relationships with top cancer experts and organizations throughout the world.

Here, we’re not just offering the latest treatments, we are at the forefront to the next generation of cures.

What is an oncology clinical trial?

A clinical trial is a process used to test new methods to treat and prevent disease.

The goal of cancer and blood disorder trials is to find new methods to treat or learn about a condition. The new methods may include:

• Looking at a patient’s tumors to learn more about the disease
• Providing new or different approaches to surgery or radiation
• Applying new methods for modifying genes or a person’s own cells through cellular therapy
• Offering new drugs and/or combinations of drugs
• Improving outcomes for the tumor or blood disorder

At Children’s Colorado, we always offer patients the best and most current treatment available, which often includes the opportunity to participate in a clinical trial. In some cases, these patients may be the first to benefit from such treatment.

What are the different phases of clinical trials for cancer?

There are different phases of testing and evaluating new or different therapy. Phase one and phase two trials are known as "early phase trials." Phase three and four trials are usually considered “later phase trials.”

Phase one trial

A phase one trial is the first use of a new method for the treatment of a disease. In this phase, the doctors want to find out:

• The ideal or maximum tolerated dose of the new treatment – how much a patient needs to take to have an effect without too many side effects
• Side effects of the new treatment
• In which patients the new treatment is most promising

The study doctor and team will closely follow the patient's care to evaluate side effects and make sure the new treatment is safe.

A phase one trial has a small number of patients who participate. Doctors may use extra tests or extra blood draws to look at how the new treatment works in the body, how the body responds to the treatment and which patients may benefit most.

Phase two trial

A phase two trial will evaluate the new treatment for a type of cancer or disease that has a specific gene abnormality or biologic marker in common.

• A small number of patients take part in this type of trial.
• The study doctors closely follow the patient's care to assess possible side effects and make sure the new treatment is safe.

Phase three trial

A phase three trial compares the new treatment to the current standard of care treatment for a certain type of cancer. It is usually considered "later phase."

The number of patients who take part in a phase three trial is much larger than phase one and two trials. In these trials, the new treatment has already shown some promise during the early phase trials, and the doctors want to see if it is better than the current standard treatment.

Sometimes these studies test whether less therapy is better or if a completely different therapy is better. For most phase three trials, researchers use randomization (like flipping a coin) to help decide which treatment each patient will be given.

Phase four trial

Phase four trials study the side effects caused by a new treatment over time after it has been approved and is on the market. These trials study side effects and effectiveness of the treatment over a long period of time and can include thousands of patients.

Clinical trial contact information

Our clinical trial options frequently vary over time. For information about trials that might be available, please visit clinicaltrials.gov, https://researchstudies.cuanschutz.edu/ or email us at ETP@childrenscolorado.org or call 720-777-5877