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The Lombardi Comprehensive Cancer Center

The Lombardi Comprehensive Cancer Center is the only center based in the Washington, DC area that is designated by the National Cancer Institute as a comprehensive cancer center. Research performed at Lombardi offers access to transformative new clinical trial options.

Clinical Trials

Click here to find links to clinical trials currently recruiting participants at a MedStar Health location in Maryland or Washington, DC. These studies are organized by health condition and provide information that will help you better understand what the clinical trials are and the criteria for enrollment.

At Lombardi we are proud of our balanced, comprehensive research expertise. These research studies help to inform doctors and scientists about new and emerging cancer therapies, how they should be used, and which patients will benefit the most from these approaches. Clinical trials help researchers find new ways to treat or prevent cancer, and assist in making sure they are safe and effective. Almost every standard cancer treatment currently in use was first made available to patients who participated in clinical trials. Through these studies, Georgetown Lombardi is able to provide personalized medical treatment to each of its patients while upholding its motto, cura personalis (care for the whole person).

What is a clinical trial?

A clinical trial is a scientific study done in human volunteers to test the safety, value and the side effects of a procedure, medication, or device. Clinical cancer trials are conducted only after meeting the approval of the National Institutes of Health (NIH). All of the steps that will be followed in the trial are set out in the study protocol. The protocol is a detailed “recipe” for how the study will be done. A study may show that the tested treatment is better than, as good as, or no better than the standard treatment for the same condition. Without clinical trials there would be few, if any, medical advances- advances that help us to treat millions of people, and  will benefit future generations worldwide who have various illnesses.

Why do we need clinical trials?

A series of clinical trials for each possible treatment must be done before the Food and Drug Administration (FDA) will approve a drug, procedure or device. Many of the trials done at MedStar Health Research Institute are trials testing possible drugs or devices. A drug must be shown to be safe and useful for public use before the FDA can approve it. From the lab bench to the drug store, developing a new drug is a long and expensive process. It is estimated to take about 10 years and 800 million dollars to bring one new drug to market (R&D Directions, January 2002).

Who can participate in a clinical trial?

People with the condition being studied or healthy people can volunteer to take part in a clinical trial. Each study has specific entry requirements such as age or a medical condition necessary for participation. The doctor in charge of the study must review the volunteers’ medical history to determine if he/she is eligible to participate based on strict study conditions called entry criteria.

Who is in charge of a clinical trial?

A medical doctor is usually responsible for carrying out the study according to the study protocol. Before a clinical trial can begin to enroll volunteers an Institutional Review Board (IRB) must approve it. The IRB is a committee made of healthcare experts that review each study to protect patient rights and ensure the safety of research volunteers. The IRB also ensures the research is scientifically sound and is involved in the review of safety issues throughout the study.

What is informed consent?

One of the documents the IRB must review and approve is called an Informed Consent Form. This form is provided to volunteers who are interested in participating in a clinical trial program. The informed consent includes everything a volunteer needs to know about the study such as risk and potential benefits, so that he/she can make an informed decision as to whether or not to participate. The process allows volunteers to ask questions. Volunteers are encouraged to take their time in making a decision before signing the consent and joining the study. You and your family should feel completely comfortable with your decision to participate before you sign the consent.

What are the benefits to being in a clinical trial?

Once enrolled in a clinical trial, many volunteers find there are a number of potential benefits to participation. These can include:

  • The opportunity to become involved in the testing of a new drug that may have the potential to improve your condition.
  • Close contact with the study team for management of your disease.
  • Contributing to medical science, which may help others now and in the future.

However, volunteers understand that there may not be any benefit to participating in a study and there may be risks associated with that therapy.

Additional Clinical Trial Resources:


Immunotherapy is a type of targeted therapy that mimics or boosts the body’s natural defenses, a particular promising target for this new line of treatment. While we study a wide range of targeted therapies, we are particularly known for our immunotherapy clinical trials—in fact, patients travel to us from all over the country for them because of the limited opportunity elsewhere. Learn more about Immunotherapy

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National Cancer Institute (NCI) Designation

The National Cancer Institute designates Lombardi a comprehensive cancer center, one of just 47 nationwide, and representing just 2 percent of cancer centers. The criteria are rigorous, focused on a center’s ability to conduct meaningful research and incorporate promising results National Cancer Institute into clinical care. The designation means:

  • Greater access to grants
  • Ability to conduct more clinical trials, giving you access to tomorrow’s therapies today and providing options to patients who may have run out of them

Some of our clinical trials attract patients from around the country. Our researchers are solving the mysteries of cancer’s origins and progression, to improve detection and prevention efforts. They’re also refining current therapies and creating better ones.

Stan Sher’s Journey with Advanced Melanoma and Immunotherapy