Education For Families
What is a clinical trial?
Generally speaking, a clinical trial is very carefully controlled study of cancer treatment involving experimental types of therapies for use in humans. Therapies can mean new combinations of drugs, brand-new drugs, new devices, etc.
Why would you participate in a clinical trial?
While each person should understand and take into account the risks a clinical trial can pose, the positives of participating include being able to take a very active role in your own healthcare, use cutting-edge of treatments, and help contribute to medical research.
Who can be a part of a clinical trial?
In order to enroll into a clinical trial, research personnel will make sure you or your child meets what we call ‘inclusion’ and ‘exclusion’ criteria. This criterion allows us to very carefully control the individual patients and the entire trial (also called a ‘study’) ensuring optimal safety.
Who is in charge of a clinical trial?
Specially trained physicians, nurses, and research associates are responsible for the management and oversight of clinical trials. These professionals are governed by federal law, ethics committees, and some trials are also governed by ‘cooperative groups’ or ‘consortiums’. These organizations are designed so that many institutions can open the same trials at the same time. This allows physicians in charge of the trials to pool their data, resources and patients allowing us to come to faster conclusions about what causes and how to better treat childhood cancers. It also means that many specially trained individuals are constantly monitoring patients and trial data so we can quickly respond to any safety concerns that may arise and make sure everyone on the study is complying with ethical and logistical regulations.
Our program primarily works with the Children’s Oncology Group (or COG) and the Pediatric Oncology Experimental Therapeutics Investigators Consortium (or POETIC). Children’s Oncology group is made up of about 220 institutions and they conduct many childhood cancer trials every year.
POETIC is a select group of institutions through the US and Canada that have been given the opportunity to participate in what we call ‘early-phase’ clinical trials. Most of these trials use brand-new drugs and have to be monitored especially carefully. Being a part of POETIC is a unique opportunity and privilege. It has allowed our program to offer some treatments that otherwise would not be available to our patients.
Interested in finding out more about clinical trials?
Specific information regarding the risks, benefits, informed consent process and other clinical trials topics can be found at www.clinicaltrials.gov. Below you can also see what the Pediatric Brain Tumor Program at the University of Florida is currently offering for patients with brain and CNS tumors.
Children’s Oncology Group (COG):
- ACNS 0331: A Phase III Randomized Trial/A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy 18 Gy and Chemotherapy in Children with Newly Diagnosed Standard Risk Medulloblastoma
- ACNS 0334: A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children < 36 Months Old with Intensive Induction Chemotherapy with Methotrexate Followed by Consolidation with Stem Cell Rescue vs The Same Therapy Without Methotrexate
- ALTE 07C1: Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children with Cancers
Pediatric Oncology Experimental Therapeutics Investigators’ Consortium (POETIC):
- A Multi-Center Phase I Study of Intravenous Deforolimus Administered QDX5 Every Other Week in Pediatric Patients with Advanced Solid Tumors
- A Phase II Study of Safety and Efficacy of Nimotuzumab in Pediatric Patients with Recurrent Diffuse Intrinsic Pontine Glioma*
*This protocol will also be open on a compassionate-use basis for patients who do not meet eligibility criteria.
For more information about current trials and eligibility requirements please contact our office at 352-273-9072 or toll free at 800-749-7424 x 3-9072.
You can also reach our Clinical Research Data Manager Emily Owens-Pickle at emily.owens@peds.ufl.edu .
Department of Neurosurgery @ UF
*For patients over the age of 18 years of age please click on link below for additional clinical trials. http://www.neurosurgery.ufl.edu/research/clinical-trials.shtml
