Clinical trials are the lifeblood of progress against cancer. Virtually all the advancements made in treating cancers are a result of clinical trials. A clinical trial is a research study designed to test whether a new approach to treating a cancer works better than the current standard therapy. There are all kinds of ways to do clinical trials. Some test new agents, or approaches to doing surgery or radiation therapy. Others test new combinations of drugs or therapies, or new ways of delivering the treatment, while still others focus on improving quality of life by reducing the side effects of treatment.
Leukemias and lymphomas have been one area in which clinical trials have had a huge impact. Childhood acute lymphatic leukemia (ALL), Hodgkin disease, and chronic myelocytic leukemia (CML) have all become diseases that can either be cured in many cases or controlled for long periods of time as a result of clinical trials. There has also been significant progress in treating other types of leukemia and lymphoma as well. There is still a great deal of work to be done, however. Some forms of blood cancer remain difficult to treat and the treatments themselves can cause both short and long term problems for patients.
Every patient with a leukemia and lymphoma should be aware of clinical trials and be treated in a cancer center that can either offer an appropriate trial of refer you to one if the need arises. Not every patient will enter a clinical trials, but it is still very important to know that there is research underway and to be able to get access to trials that are underway.
One of the myths about clinical trials is that they are only for patients who have exhausted all other forms of therapy. The truth is that there are trials for every stage and type of cancer. The goal is always to improve the outcomes of treatment while reducing the side effects.
Clinical trials are generally done in three phases.
Phase I: These trials are for new drugs or agents which researchers believe may be effective in treating cancers. The first step is to determine if the drug is safe and what side effects it has at what doses. Phase I trials are sometimes done for a range of cancers, rather than a specific cancer type. Patients on phase I trials frequently have advanced cancers that have not responded to other forms of treatment.
Phase II: If a new drug or treatment approach seems promising, the next step is test it in groups of patients with a specific cancer or stage of cancer. The goals for Phase II trials are often to measure whether the new approach improves survival compared to the standard therapy. Phase II trials also look very carefully at the side effects of the new treatment.
Phase III: Phase trials are large studies which generally randomize patients into two or more types of treatment. One group will get the new approach while the other receives the standard treatment. The results are carefully compared to determine if there is a real advantage to the new treatment. All clinical trials have very specific goals or end points that they must meet in order to be considered successful.
If a clinical trial demonstrates that a new therapy is safe and effective, the Food and Drug Administration will approve that drug or approach for a specific cancer or even a specific stage or subtype of cancer. All patients who enter clinical trials go through a process of informed consent in which they are told of all the possible benefits and potential side effects of the treatment. Clinical trials patients receive state of the art care during and after their trial.
Patients participate in clinical trials for many reasons. For some patients, a clinical trial offers the best hope for improved survival or quality of life. For others, participating in a clinical trial is a way of helping to make progress in treating cancer.
Leukemias and lymphomas are a very diverse group of cancers. There are many different types and each one has a number of subtypes, all of which have different treatment approaches and prognoses. There are many trials underway to improve the treatment of blood cancers. Much of this research focuses on finding new agents to treat these cancers, especially drugs that target a specific characteristic of the cancer cells. There is also a great emphasis on finding better ways to treat blood cancers that have either not responded to current therapies or recur after treatment. Finally, the treatments for blood cancers, even when they are very effective, frequently cause both short and long term side effects. Researchers are very interested in finding new treatments that are at least equally effective but result in fewer problems.
The best source of information about clinical trials should be your doctor or treatment team. Blood cancers are complex diseases and should be treated in centers which have experience and expertise in treating these cancers. Part of the expertise is being able to offer or refer a patient to a clinical trial when it is appropriate.
Patients can find information about clinical trials from a number of on-line sources. The Leukemia and Lymphoma Society, Trialcheck.org, cancer.gov all have search engines for specific clinical trials, as well as more general information about current research. NCCN.com offers guidelines for treatment for many types of cancer in patient friendly language. Cancer.net and Oncolink.com have extensive information about specific cancer types and their treatment, as well as ongoing research.
It can be very hard for a patient to locate an appropriate clinical trial. Trials have many requirements for participation based on the exact type of cancer, its stage, previous treatment and the overall health of the patient. Getting good information is very important, but finding the right clinical trial for a blood cancer means working with your doctors and taking a proactive role in doing research on your own as well. New clinical trials are created all the time. Following are organizations that offer free databases of cancer clinical trials, You can also check the websites of individual medical/cancer centers in your local area, drug manufacturing companies, and patient advocacy organizations including the Lymphoma Research Foundation and the Leukemia and Lymphoma Society.
National Cancer Institute (NCI) Clinical Trials: The NCI, part of the National Institutes of Health, is the federal agency that provides funding for most U.S. cancer clinical trials. This comprehensive site provides information on both open and closed cancer clinical trials that are funded by the government, as well as many sponsored by pharmaceutical companies, medical centers, and some international organizations. Visit Website
The National Institutes of Health (NIH): This clinical trials site is sponsored by the National Library of Medicine and the National Institutes of Health includes hundreds of lymphoma trials sponsored by the NCI, health institutions and the pharmaceutical industry, with links to published medical literature. Under the resources section of this site are links for information on clinical trials, how to participate in a study, a glossary of clinical trial terms, and links for other resources. Visit Website
CenterWatch: This is a publishing and information services company that offers a list of institutional review board (IRB)-approved clinical trials. Visit Website
EmergingMed Navigator: EmergingMed offers a phone and Internet-based service that identifies clinical trial options which match a patient's specific diagnosis, stage and treatment history. Clinical trial specialists provide telephone support upon request to help connect eligible patients with IRB-approved study sites that are enrolling new participants. Visit Website
TrialCheck: TrialCheck is an online search engine where people can find tailored information about cancer clinical trials that are enrolling patients at hospitals, cancer centers, and oncology practices in the U.S. and internationally. Visit website
WHO International Clinical Trials Registry Platform Search Portal: The World Health Organization (WHO) coordinates health matters within the United Nations. This database allows people to search clinical trial registration information from many countries' registries. Visit Website
Additional Web sites that offer partial listings of lymphoma trials:
www.cancertrialshelp.org: Sponsored by the Coalition of National Cancer Cooperative Groups, the Coalition's Web site provides information on the clinical trial process, informed consent, insurance coverage, and questions to ask your doctor. This site also offers a link to the TrialCheck matching service, which allows patients to search for trials based on specific questions on their condition and save the results.
