Clinical Trials: What Every Cancer Patient Should Know

Clinical Trials: What Every Cancer Patient Should KnowTrials offer patients a chance to benefit from the latest treatments

If you or a loved one is diagnosed with cancer, you’ll want to seek the highest possible level of care—and clinical trials can be a critical aspect of that care. “Clinical trials offer tomorrow’s treatments today,” says Howard S. Hochster, MD, FACP, Director, Oncology Research for RWJBarnabas Health, and Associate Director, Clinical Research and Director, GI Oncology for Rutgers Cancer Institute.

“As the state’s only NCI-Designated Comprehensive Cancer Center, Rutgers Cancer Institute of New Jersey and RWJBarnabas Health provide patients access to a wide range of clinical trials, many of which are not available elsewhere. We do this at Rutgers Cancer Institute in New Brunswick and across the state at RWJBarnabas Health hospitals.” What should patients know about clinical trials? Dr. Hochster explains:

What happens in a clinical trial?

Clinical trials are research studies that evaluate new treatment options for diseases and help doctors learn which treatments are most effective. Generally, clinical trials evaluate the safety and effectiveness of new drugs, use current drugs in a new manner or combine drugs to evaluate their effectiveness. Every clinical trial must be approved by regulatory authorities to be sure the scientific evidence merits this kind of investigation and that it’s ethically sound.

Clinical trials are undertaken only when we have evidence that the new approach is likely to be better than the standard treatment. Patients should speak with their physicians about the risks and benefits, including possible side effects, of the treatment being studied. During a trial, patients will have many staff members paying attention to them—physicians and research staff including nurses, data managers and others—whose job is to make sure they get the treatment exactly as written in the protocol.

Who’s eligible for a clinical trial?

Every patient who has a cancer diagnosis should ask whether a clinical trial might be right for him or her, and should consider a clinical trial at every step of the cancer journey. Sometimes a trial isn’t appropriate at the beginning, but may be later on. Requirements for participation vary. Criteria may include age, gender, type and stage of cancer, other existing medical conditions and treatment history. Before patients can participate in a clinical trial, they must sign an informed consent document, which explains all aspects of the trial as well as alternative treatment options.

What are some examples of cancer research taking place in clinical trials?

For years, everyone with certain cancer diagnoses received the same type of treatment for their cancers, but not everyone reacted the same way. Now we’re able to use clinical trials to make progress in precision medicine, where we can specifically target, on a molecular level, the gene mutations or changes that make an individual’s normal cells turn into cancer cells. Another exciting area now is immunotherapy—using a person’s own immune system to fight cancer. We’ve learned that cancer cells have ways to mask themselves from the immune system.

Today, we’ve seen many breakthroughs in drugs that restore the body’s ability to fight off cancer cells. CAR T-cell therapy is another promising area of research. It involves obtaining immune cells from a patient, reengineering them in a lab to make them as effective at fighting cancer as possible, then reinjecting them into the patient’s body. This results in a “ living” therapy with ongoing benefit. Currently, Robert Wood Johnson University Hospital in New Brunswick, in conjunction with Rutgers Cancer Institute, is one of only two certified programs in the state to offer this form of immunotherapy.

A clinical trial for COVID-19 treatment

Rutgers Cancer Institute is spearheading a statewide clinical trial for the drug hydroxychloroquine as a potential treatment for COVID-19 patients. Though the trial is not limited to cancer patients, Rutgers Cancer Institute is well positioned to lead such a study because of its extensive experience with clinical trials as the state’s only NCI-Designated Comprehensive Cancer Center. Hydroxychloroquine, while a subject of much public discussion, has not yet been tested in a large, controlled clinical trial to determine its effectiveness.

“Until we get the results of a clinical trial, we just don’t know if there’s any role for hydroxychloroquine in treatment for COVID-19,” says Rutgers Cancer Institute Director Steven K. Libutti, MD, who is also Senior Vice President, Oncology Services, RWJBarnabas Health, and Vice Chancellor, Cancer Programs, Rutgers Biomedical and Health Sciences.

“Both the initial hype about the benefits of hydroxychloroquine and the stigma that followed were inappropriate. With this trial, we’ll have well-analyzed data from a well-conducted study in order to make a recommendation about that agent’s use.”

Three pathways

The study consists of three “arms.” One will test hydroxychloroquine in conjunction with the antibiotic azithromycin; one will test hydroxychloroquine alone; and one will provide supportive care for six days, followed by a course of hydroxychloroquine. Patients’ blood will be tested for levels of the SARS CoV-2 virus prior to treatment and at regular intervals thereafter. The study is open to people who are age 18 or over, have been diagnosed with COVID-19 and meet other eligibility requirements.

In addition to Rutgers Cancer Institute in New Brunswick, the trial is being offered at Robert Wood Johnson University Hospital in New Brunswick; Monmouth Medical Center in Long Branch; Saint Barnabas Medical Center in Livingston; Morristown Medical Center; Overlook Medical Center in Summit; and University Hospital in Newark. For information on how to take part in the trial, call Rutgers Cancer Institute’s Office of Human Research Services at 732.235.7356 or email statewide_research@cinj.rutgers.edu.

To learn more about clinical trials, visit www.cinj.org/clinical-trials. To speak with a clinical trial navigator to explore your options, call the Oncology Access Center at 844.CANCERNJ.