March 1, 2014 | by Kim Proescholdt
Research studies known as clinical trials have led to countless advances in the diagnosis, treatment and prevention of cancer. These studies test the effectiveness of new medical approaches that can lead to fewer treatment-related side effects and, in some cases, improved outcomes for patients with certain cancers.
But many patients know little about clinical trials, much less what’s involved to participate. Here, Leslie Popplewell, associate professor in the Department of Hematology & Hematopoietic Cell Transplantation at City of Hope, explains how clinical trials work and how patients and their families can make informed decisions about participating in trials.
What are clinical trials, and why are they important?
Clinical trials are a way of delivering a promising new drug or combination of drugs to patients. Trials typically have a strict set of guidelines on which patients can be treated (“are eligible”), and they're carefully controlled so that the results can be recorded and the outcomes reported in a scientific way.
Usually clinical trials are designed to test new drugs, or drugs that have been in use for a while, but are now used in a different setting or patient population than previously. A clinical trial may also offer a new drug combination that hasn’t been used before.
As physicians, we need to be able to tell people what they can expect in terms of their disease response to this regimen. Clinical trials give us that data, while making new treatments available to patients.
Are there different types of clinical trials?
There are three different levels, or phases, of clinical trials. Phase I trials test new drugs that look promising in the laboratory but may not have been tested extensively in patients before. Phase I trials take groups of patients through treatment. Patients who enter the trial at later dates often receive higher doses of the new drug. The process is continued until the maximum dose is determined.
In phase II trials, a single dose in a defined patient population gives us information about the overall efficacy of the drug in a specific patient population.
In phase III trials, we’re looking at what’s the outcome in a head-to-head comparison of an old method versus a new method of treatment.
Who should consider enrolling in a clinical trial, and why?
Even though there have been many advances in the treatment of cancer, there is much more work to do. When patients come to City of Hope, we need to understand and define their treatment goals, discuss what can be expected from conventional treatment and then, if something new is proposed, discuss what the added risks and benefits may be from enrolling in a clinical trial. The status quo is not good enough.
City of Hope has a portfolio of trials available for almost anyone. There are studies for patients who have newly diagnosed disease, those who have unfortunately relapsed after prior treatments, and then there are trials for those patients who have exhausted more conventional treatment regimens. Anything we can do to try and improve the outcome for any patient that comes to us is worth the effort.
What are some innovative clinical trials available at City of Hope?
Some of the exciting trials open now and/or opening in the next few months are trials including a treatment called “adoptive immunotherapy.” Adoptive immunotherapy involves taking cells from patients and inserting genetic information into those cells to produce “anti-cancer” activity. We’re adapting this kind of therapy for patients with lymphoma and have been doing so for over 10 years now. However, recently this approach has been adapted for patients with multiple myeloma. There are also new trials opening up for leukemias and even solid tumors, such as ovarian cancer.
What inspires you to do the work you do?
When I first became a doctor, I was immediately drawn to cancer therapy. I enjoy the interaction between the patient and physician, and that feeling of being part of team. As a physician, you have to have that five- to 10-year goal in mind when you talk with a patient because you know you’re going to be together for a long time. I also enjoy collaborating with my colleagues in surgery, radiation and medical oncology to design successful treatment regimens. We have cure in mind when we treat patients, even those with relapsed disease. We all want the best outcomes and that inspires me daily to do the best I can.
What advice do you have for patients interested in enrolling in a clinical trial?
My first bit of advice to patients is to be open to the idea of participating in a clinical trial. The importance of having two-way communication with your physician is vital, because you as the patient need to know and understand the risks and benefits of enrolling in a trial.
Ask lots of questions. Know the goals of the trial. Ask how the trial treatment differs from what conventional therapy would be available. The consent process for a clinical trial requires a serious dialogue, and that consent process doesn’t end with “signing on the dotted line.” The right goal is to have the best possible outcome for that patient.
For more information and a full listing of clinical trials available at City of Hope, visit clinicaltrials.coh.org.