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As part of the extraordinary gift from the Skip Viragh Foundation, the Johns Hopkins Kimmel Cancer Center has established an investigators program that provides funding for faculty to use toward developing newer, more effective treatments for patients suffering from tpancreas cancer.
“The National Institutes of Health (NIH), right now, is averse to funding projects that may have scientific rationale but not a lot of clinical data,” explains Daniel Laheru, M.D., associate professor of oncology. This initiative offers much needed funding for preliminary research so that scientists can better compete for federal funding down the road with data in hand.
Laheru says the monies will be used to fund from one to three investigators per year at an amount equivalent to an NIH grant.
Medical oncologist Dung Le, M.D., is examining how pancreas cancer vaccines, combined with other agents, can elicit tumor-specific immune responses. Pancreas cancer cells secrete a substance that prevents the body’s normal immune response. Le’s work attempts to interrupt that signaling pathway, either by inhibiting negative signals that cancer cells use to turn off the immune system, or by accelerating the positive signals produced by immune system T-cells.
One study under way is the treatment of pancreas cancer patients using an immunotherapy approach. Le is working with Daniel Laheru, M.D., and Elizabeth Jaffee, M.D., to translate cancer vaccine therapies that have been developed in the laboratory into clinical trials. In another study, she currently is directing a Phase II clinical trial to evaluate the effectiveness of ipilimumab (an antibody that blocks negative signals to T-cells) in patients with metastatic pancreas cancer. She is testing the efficacy of ipilimumab alone and in combination with a pancreas cancer vaccine.
Additional studies are examining the combination of vaccine platforms with immune checkpoint inhibitors such as anti-PD-1 and CTLA-4 inhibitors, as well as other inhibitory molecules in the tumor like indoleamine 2,3-dioxygenase.
“Her research has enormous implications in immunotherapy, but because much of this work is still new, the NIH would likely not fund this project until more data was generated,” Laheru says. “We believe that funding high-level science that can lead to new advances in how we manage patients with pancreas cancer is one of the key missions of the program.”
De-stressing the Clinical Trials Process
As part of the Skip Viragh Foundation’s gift to the Johns Hopkins Kimmel Cancer Center, clinical staff are able to pursue advanced degrees on topics related to improving patient cancer. A new grant allows veteran oncology research nurse practitioner Barbara Biedrzycki to lead studies that focus on patient-oriented issues such as quality of life, informed consent, and participation in clinical trials.
Biedrzycki will spend 2010 completing her Ph.D., doctoral dissertation on patient decision-making and outcomes in clinical trials. She notes there is little in the medical literature on the decision-making process of patients regarding clinical trials. Her research is intended to fill the gap.
Caring for Patients
Biedrzycki is part of a clinical team with strong nursing experience. During 2009, she served as the multidisciplinary clinic coordinator for newly diagnosed patients. Before stepping into that role, she cared for patients enrolled in clinical trials for pancreas and other GI cancers. Biedrzycki believes that “we are called to fulfill a unique responsibility”. She explains that clinicians who care for people with cancer are entrusted with patients’ needs at a time when they are most vulnerable:
“Our care involves not only healing their physical ailments, but also helping them to adjust to a life living with cancer. Patients are faced with so many new challenges and decisions when diagnosed with cancer,” she says.
Because the participation rate of adults in cancer clinical trials has remained low for more than two decades, Biedrzycki is looking at factors influence patients’ decision-making processes and then developing plans for future clinical trials that increase patient satisfaction.
As part of her study, Biedrzycki reached out to patients who completed an initial consultation at Johns Hopkins, or, who had just been offered the opportunity to participate in a clinical trial.
Biedrzycki then sent a survey to a subgroup of patients with advanced stage pancreatic or colorectal cancer. The survey asks for information about quality of life, symptom distress, decision-making preferences, and level of hope. In addition, she is conduction patient intervieiws designed to capture the thoughts and feelings of patients that are new to the clinical trials process or still deciding whether or not they want to participate in one.
Biedrzycki expressed gratitude and admiration for the patients who have responded so far. She noted how dedicated people were, and how patients with even advanced pancreatic cancer would take the time and energy to complete the survey.
One patient, who brought it back and forth on three visits to Johns Hopkins Hospital, felt it was “so important to get this finished, to let you know how I feel”. Another patient observed that the survey “really made me think about spirituality and hope. It helped me to open up and talk with my family.”
After the survey portion of her study is complete, Biedrzycki will analyze the results and then make recommendations on how to improve the clinical trials process.