- If there is a chance that the patient would benefit from being treated by a test drug
- If no other therapy is available that would be of greater benefit to the patient
- If there is an open trial available that matches the patient’s disease and overall condition
- If a patient is healthy enough and physically able to participate in a study
- If the patient is able to come to the facility on a regular basis, sometimes up to four or five days a week for several weeks
Anita Marie Whiteway was running out of options when she came to Yale Medicine doctors in 2013 to participate in a research study for a then experimental lung cancer drug. Today, although she still undergoes regular immunotherapy treatments, she has had no evidence of lung cancer for two years. “I just wish more people were as fortunate as I am,” says Whiteway, 74, a retired librarian from Enfield.
Hers is the kind of success that patients hope for when they participate in Phase I clinical cancer trials—the first step in the testing of a new drug. These volunteers have run out of effective conventional treatment choices. They hope for near-miracles for themselves and want to help improve the health outcomes for other patients. Whiteway is cared for at the recently opened Phase I clinical trials infusion center at Smilow Cancer Hospital at Yale New Haven. She and other patients who are in Phase I cancer trials go to the center, which is located on the first floor of 55 Park Street, for their treatments. Drugs that pass rigorous testing and review in these clinical trials may eventually gain Food and Drug Administration (FDA) approval to help cancer patients for generations to come.
“Every patient here volunteers to be the subject of a clinical experiment, and they sometimes give the most precious last days of their lives helping science and potentially helping other patients,” says Patricia LoRusso, DO, a Yale Medicine medical oncologist, who is the director of the Phase I Clinical Trial Infusion Center. She is also the associate director of innovative medicine at Yale Cancer Center. “The patient is the hero."
Volunteering in this way is a gift to other patients that Whiteway feels proud to have given. “I feel so fortunate that those of us who are in the trial can help other people in the future,” she says.
The new, welcoming facility is significantly larger than the space previously used on the eighth floor of the building and is dedicated to just Phase I cancer trials. In designing the new space, close attention was given to the comfort of the people receiving treatment. There are private treatment areas with heated massage chairs for patients receiving cancer care. The larger space also gives researchers the capacity to expand the number of clinical trials conducted, potentially treating even more patients with various types of cancer. Currently, Yale Medicine doctors and Smilow Cancer Hospital have about 37 Phase I clinical trials open to new patients.
“This new center represents the integration between science and clinical research where cutting-edge research meets outstanding clinical care, offering patients new hope and new treatments that would otherwise not be available to them,” says Rogerio Lilenbaum, MD, chief medical officer at Smilow Cancer Hospital. Patients travel from across the country and the world to take part in these trials.
Who can participate in cancer clinical trials?
Not every patient is a candidate to participate in clinical trials, and there are a variety of considerations, including a patient's overall health and the availability of an open cancer clinical trial for which a patient is eligible. A patient’s journey through experimental cancer treatment
Whiteway recalls that since she was a non-smoker, she never expected to get lung cancer. She had been healthy all of her life. “I figured I wasn’t going to die from anything other than just old age, and then I went and got cancer,” she says. After diagnosis, she had surgery to remove part of her left lung at a Hartford-area hospital. A CT scan in 2012 revealed her cancer had returned, so she underwent 12 weeks of radiation followed by several months of chemotherapy.
“My progress was all over the place,” she recalls. “The doctor suggested I go to Yale and take part in a clinical trial.” She was accepted into a trial to investigate the effectiveness of pembrolizumab, a drug for non-small cell lung cancer, the type of cancer she has. In fact, she got the last spot in that study. Pembrolizumab works by triggering the patient’s own immune system to target the disease. It was granted FDA approval in October 2015 under the brand name Keytruda, and it’s currently used for lung cancer patients like Whiteway.
Her doctor is Joseph Paul Eder, MD, a Yale Medicine oncologist. He describes the immunotherapy treatment she received as “revolutionary.” With this treatment, the patient’s own immune system is triggered to fight off the disease, he says. The drug has less severe side effects than those associated with traditional chemotherapy treatment such as nausea, pain and mouth sores.
Today, Whiteway is able to live a normal life doing what she loves, which includes tending her gardens, caring for her husband and keeping her large home in tip-top shape.
Above all, she feels optimistic about her future. “I always said I’m going to live to 86,” says Whiteway with a chuckle, and she’s more determined than ever to get there.