Clinical trials test new and potentially unproven therapies on humans. Are they really safe? Can they really provide me with another treatment option?
Almost all modern cancer treatments have become possible because of patients willing to be the first to try new, previously unheard of therapies. Clinical trials are conducted in different phases, all of which undergo review by independent scientific and ethical boards composed of both medical professionals and non-medical persons. This process ensures validity, safety and ethical conduct of the studies.
Phase I studies are designed to test a treatment or drug either for the first time in humans or in a way that has not been tested before. These studies help determine the safety of the therapy and are rarely offered as the first treatment option if a standard treatment already exists for the cancer. Phase II studies evaluate the effectiveness of a therapy, usually a treatment resulting from prior testing in humans. Phase III studies randomly assign willing trial participants to one of two or more treatments, in which the patient does not choose which treatment they will receive. These studies help to determine which active treatment works best.
The decision to participate in a clinical trial is personal. Patients must weigh many factors in this decision carefully. If you are considering participation in a clinical trial, don’t be afraid to ask your oncologist to address any concerns you may have, such as the risks or benefits of the trial.
Find more information on the clinical trials offered at Siteman Cancer Center here.
Immunotherapy has been in recent news as a revolutionary treatment for leukemia. What is it and can it treat my leukemia?
Although still in the early stages, clinical trials of chimeric antigen receptor (CAR) T cells to treat B-cell acute lymphoblastic leukemia (ALL) look very promising. CAR-T cell therapy is a novel cellular immunotherapy in which the patients own white blood cells are genetically modified to recognize and attack leukemic cells.
T cells are a type of immune cells that circulate throughout the bod, searching for abnormal cells, or cells expressing foreign proteins. Each T cell has a unique receptor that allows it to recognize a specific protein on the cell surface of target cells. For example, certain T cells carry receptors that recognize and kill cells expressing proteins related to the common cold virus. Through research, a new approach has been developed to modify T cells to recognize leukemia. Many patients who have received infusions of these engineered CAR-T cells have experienced rapid clearance of their leukemia.
Though results have been promising, this type of immunotherapy is currently only available through a clinical trial, as it is not yet FDA approved. Also, only patients with B-cell ALL or B-cell non-Hodgkin lymphoma or whose disease is relapsed or refractory to standard chemotherapy are eligible for this clinical trial. However, research is ongoing to expand CAR-T cell therapy to other types of cancers.
At Washington University and Siteman Cancer Center, many clinical trials using CAR-T cells or immunotherapy are in progress. Read about another exciting trial that uses immunotherapy to treat acute myeloid leukemia (AML) in this issue of SPORE In Touch.
For additional information, or to find out if you are eligible for one of these therapies, speak with your oncologist.