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The Experimental Therapeutics Program (ETP) is part of the Center for Cancer and Blood Disorders (CCBD) at Children's Hospital Colorado. Our care team is committed to serving patients who have recurrent cancer, a disease that has not responded to typical chemotherapy treatments or a diagnosis that has no reasonable cure.
Our program offers children, adolescents and young adults access to phase I trials, many of which are first-in-pediatrics protocols available at a very limited number of institutions. Our specialty physicians and staff have worked with patients from more than 45 states and 23 foreign countries.
Our program is one of a few select centers in the United States and Canada that offer and support experimental therapies to patients with relapsed cancer or cancer that is resistant to treatment. We’re part of many major cooperative groups and National Cancer Institute-sponsored collaborations including:
Each team in the CCBD works with the Experimental Therapeutics Program team to ensure smooth and efficient transition of patient care that ensures expertise in the patient’s specific disease, whether they come from within our program or across the globe.
Our Experimental Therapeutics Program is staffed by:
Board-certified pediatric oncologists, specializing in phase I and phase II trials
Certified pediatric nurse practitioners and physician assistants
Experienced oncology research nurses
Data and regulatory specialists
A creative arts therapist, an addition to our team resulting from our nursing-led research that established the positive role art, music and movement therapy have on quality of life
Together with our pediatric colleagues from many specialties, we are one of 16 Pediatric Clinical Translational Research Centers (CTRA) in the country in the Colorado Clinical and Translational Sciences Institute (CCTSI) at the University of Colorado. We provide consultations about entry into early clinical trials of novel therapeutic strategies and agents.
An oncology clinical trial is a process used to test new methods to treat and prevent cancer. The new methods may include new approaches to surgery or radiation, new methods for gene or cellular therapy or new drugs and combinations of drugs. Patients who take part in a clinical trial have the chance to participate in newly identified therapies and may be the first to benefit from such treatment.
Understanding the phases of clinical trials
There are different phases to new therapy. Phase I and phase II trials are known as "early-stage trials."
Phase I trial
A phase I trial is the first use of a new method for treatment of a disease. In this phase, the doctors want to find out:
The ideal or maximum tolerated dose of the new treatment
Side effects of the new treatment
In whom the new treatment is most promising
The study doctor will closely follow the patient's care to evaluate side effects and make sure the new treatment is safe.
A phase I 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 II trial
A phase II 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 III trial
A phase III 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 III trial is much larger than phase I and II. For most phase III trials, researchers use randomization (like flipping a coin) to help decide what each patient should be given for treatment.
Subspecialty consultation/management is available 24 hours a day at Children's Colorado. We offer the following services to patients participating in the Experimental Therapeutics Program:
Liver, kidney, eye, head and neck, cardiac, bowel and bladder surgical procedures
Minimally invasive procedures, including thoracoscopy, laparoscopy and image-guided techniques
Neurosurgery, including stereotactic techniques
Orthopedic surgery, with a focus on limb preservation if possible