Article previously published in the Cutaneous Lymphoma Foundation's Forum Fall 2011 newsletter.
Clinical trials can offer a promising treatment option for people living with cutaneous lymphoma, especially when a patient finds their disease is unresponsive to therapies that are currently approved by the Food and Drug Administration (FDA).
Clinical trials are research studies that investigate new or experimental treatments in patients living with a specific disease.
Clinical trials are important because they contribute to the overall knowledge and progress in understanding diseases such as cutaneous lymphoma, and they also play an instrumental role in the development and FDA approval of new therapies. Very importantly, a patient who participates in a clinical trial may personally benefit from an investigational treatment they are receiving as part of a clinical trial – they may experience a complete response, see improvement in their quality of life or find relief from symptoms. To continue expanding the treatment landscape for cutaneous lymphoma and potentially make a difference in the lives of patients, it’s imperative that individuals living with cutaneous lymphoma consider participating in clinical trials.
There are different types of clinical trials, including treatment trials that test experimental therapies or combinations of drugs; prevention trials that look for better ways to prevent disease and/or disease reoccurrence; diagnostic trials that identify better tests for diagnosing a disease; screening trials that work to detect disease; and quality of life trials that aim to improve comfort for individuals with a chronic illness. All clinical trials follow a defined protocol and are divided into phases:
- Phase I involves administering a drug to a small group of subjects that are initially tested to determine the best method for administering a drug and the safest dose.
- Phase II works with a slightly larger group of patients to test the efficacy or effectiveness of the drug.
- Phase III is an even larger group that usually involves comparing the new treatment to a traditional or current standard treatment.
If the results from phase III are favorable for the new drug, the results of the trial may be presented to the FDA for approval of the treatment; and
- Phase IV, or post marketing studies, assess information such as the drug’s risks, benefits and optimal use.
Larisa Geskin, MD, Director, Cutaneous Oncology, Columbia University Medical Center (At time of publication: Associate Professor of Dermatology, University of Pittsburgh)
Stuart Lessin, MD, Medical Directory, KGL Skin Study Center
Pierluigi Porcu, MD, Director, Hematologic Malignancies and Hematopoietic Stem Cell Transplantation Division, Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital (At time of publication: Associate Professor of Internal Medicine, Division of Hematology-Oncology, Ohio State University Comprehensive Cancer Center)
Marianne Tawa, RN, MSN, ANP, Nurse Practitioner, Dermatology and Cutaneous Oncology, Dana Farber Cancer Institute
If you are interested in participating in a clinical trial, the decision is one that can be made with your physician and the help of a support network. Since your doctor knows your health history, he or she can assist you in locating a trial and answer any questions you may have.
A few questions to ask your doctor or team might include:
- What are the potential benefits and risks of the study?
- What side effects may occur?
- May I continue with my current treatment regimen for CTCL?
- In what ways will I be limited in my daily life as a result of the study?
- If I withdraw, will it affect my normal care?
In addition to asking your doctor, online resources such as www.ClinicalTrials.gov, www.nci.gov and the Cutaneous Lymphoma Foundation’s website can help you find current cutaneous lymphoma clinical trials. These sites provide information about both federally and privately supported clinical trials available in your area and they also include contacts and methods to request more information on a specific study.
Once you and your doctor have identified a cutaneous lymphoma trial that’s right for you, the trial’s team of doctors and nurses will explain the study protocol, and you will learn about trial details through an “informed consent” document prior to enrolling. The informed consent process outlines the trial’s purpose, duration, required procedures, key contacts and risks as well as potential benefits. If you agree to join the trial, you will be asked to review and sign the informed consent document. Additionally, many trials require a medical screening beforehand to ensure that you meet the study’s health requirements and that the trial is safe for you.
Over the course of the trial, you will be working closely with the trial’s team of doctors, nurses and researchers. You will probably be seeing them more often than usual. Do not hesitate to ask them any questions you may have or raise concerns. Additionally, you may wish to bring a friend or relative with you for support. It is also important to ask what parts of the study will be covered by insurance, and what parts will be covered by the study or trial.
Like any study, clinical trials do pose potential risks, which should be discussed in detail with your physician. However, the potential benefits can be long-lasting and life-changing.
Clinical trials empower patients to play an active role in their own care and open them up to access new treatments before they are widely available.
During the course of the trial, patients will often receive care at leading health care facilities and be under the supervision of expert physicians within the cutaneous lymphoma field.
Ultimately, participation in clinical trials helps all cutaneous lymphoma patients by contributing and potentially furthering medical research.
Marianne C. Tawa, RN, MSN, ANP, Nurse Practitioner Dermatology & Cutaneous Oncology, Dana Farber Cancer Institute