The Experimental Therapeutics Program (ETP) is part of the Cancer and Blood Disorders at Children's Hospital Colorado. The ETP is committed to serving those patients with recurrent illness, those whose disease has not responded to traditional treatment and those with a diagnosis that has no reasonable cure.
The medical staff of ETP 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 ETP program is one of 10 centers in the United States and Canada that offer certain experimental therapies to patients with relapsed or refractory disease. Our ETP physicians and personnel have worked with patients from more than 23 states and many foreign countries.
About our clinical services and programs
The 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
- Investigational pharmacists
- Data and regulatory specialists
- We are a founding member of the Pediatric Oncology Experimental Therapeutics Investigators’ Consortium (POETIC), an international association dedicated to the advancement of promising therapies for the treatment of cancer in children, adolescents and young adults.
- We are one of 16 Pediatric Clinical Translational Research Centers in the country.
We provide consultations about entry into early clinical trials of novel therapeutic strategies and agents.
- Our program engages in continuous review for medical and ethical integrity in study conduct by the Scientific Review Committee of the University of Colorado Cancer Center and the Colorado Multiple Institutional Review Board, as well as the National Cancer Institute and the US Food and Drug Administration.
What is a clinical trial?
An oncology clinical trial is a process used to test new methods to treat and prevent cancer. The new methods may be things like new approaches to surgery or radiation, or new methods for gene therapy or new drugs and combinations of drugs. Patients who take part in a clinical trial have the chance to participate in front-line therapies and may be 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. The study doctors want to find out the maximum tolerated dose of the new treatment, its side effects, and in whom it 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 take part, and extra blood is drawn 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 to a specific type of cancer. It also has a small number of patients who take part in the 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 the Phase I and II. Most Phase III trials use randomization (like flipping a coin) to help decide what each patient should be given for treatment.
Specialized surgical services
Subspecialty consultation/management is available 24 hours per day at Children's Hospital Colorado. We offer the following surgical services to patients participating in the Experimental Therapeutics Program:
- Liver, kidney, eye, head and neck, cardiac, bowel, bladder, etc.
- Minimally invasive procedures (thorascopy/laparoscopy; image-guided techniques)
- Neurosurgery; stereotactic techniques
- Orthopedic surgery, with a focus on limb preservation if possible
- Radiation therapy
- Special resection techniques
- Venous access
Get answers to frequently asked questions about clinical trials.