The best medical care is evidence-based—supported by volumes of data from carefully conducted clinical trials that started in a laboratory and held promise throughout testing in pre-clinical models, progressing ultimately in patient care facilities across the world.
Formal training in designing and implementing clinical trials, however, is not part of the medical training model.
For UC Cancer Institute-affiliated oncologists Jess Guarnaschelli, MD, and Nagla Karim, MD, PhD, having that type of experience wasn’t an option—they considered it mandatory in achieving a shared goal of becoming a true "clinician-scientist,” practicing medicine while spending part of their time designing and conducting clinical trials.
Guarnaschelli and Karim will get that training by participating in the 2012 Methods in Clinical Cancer Research Workshop, a highly selective training program sponsored by the American Society of Clinical Oncology (ASCO) and American Association for Cancer Research (AACR).
The conference takes place in Vail, Colo., July 28 through Aug. 3. Less than 100 trainees are accepted into the program nationwide.
A sort of cancer clinical trials "boot camp,” this intensive workshop provides clinical fellows and junior clinical cancer researchers with knowledge in the fundamentals of effective clinical trial design for therapeutic cancer treatments.
The workshop is designed to give step-by-step coaching on every aspect of protocol development—from introduction to data collection methods—with the benefit of expert critiques and corrections along the way to ensure attendees leave with a clinical trial protocol that is more likely to receive positive feedback from the Institutional Review Board.
"Giving talented and energetic young clinicians the tools they need to do conduct meaningful clinical research studies—mentorship, formal training in clinical trial design and institutional support infrastructure—is vital for maintaining momentum on research concepts that could positively impact patient care,” says Franklin Smith, MD, professor of medicine and Pediatrics at the UC College of Medicine and clinical director for the UC Cancer Institute. Smith was a one of several faculty mentors for Guarnaschelli and Karim and has served as part of the teaching faculty for the ASCO/AACR clinical trials workshop for two years.
Protecting Against Radiation-Induced Hearing Loss
Radiation treatment can treat and control tumors of the brain, head and neck, prolonging a person's life and sometimes completely eradicating disease. Extending life is of paramount importance, but so is preserving quality of life.
Despite advances in radiation physics and techniques, 20 to 50 percent of acoustic neuroma patients experience radiation-induced hearing loss. These non-cancerous growths arise from the eighth cranial nerve.
"Radiation-induced hearing loss significantly affects my patients’ quality of life,” says Guarnaschelli. "For patients with acoustic neuromas, we aim for long-term control of their disease, but must also consider how radiation sequelae impact their professional, social, and family lives." Guarnaschelli decided to research how radiation-induced hearing loss could be mitigated.
Efforts have been made to reduce the effects of radiation on the inner ear structures, says Guarnaschelli, but few studies have looked at radio-protective drugs specifically for the inner ear.
Guarnaschelli has developed an initial phase-2 study to investigate whether amifostine—
the only FDA-approved radio-protective drug—could preserve hearing in patients undergoing multi-session radiosurgery for acoustic schwannomas. Studies have shown that when amifostine is administered before chemotherapy or radiation, it provides broad-spectrum cytoprotection of hematologic, renal, neural and mucosal tissues without reducing the anti-tumor effect.
Upon completion of the ASCO/AACR workshop, Guarnaschelli says she hopes to have skills to be an independent clinical investigator: "The course brings together top-notch clinical researchers, biostatisticians and patient advocates. The schedule is full with didactic lectures and small group sessions. I understand the pace may be fast and the learning curve is steep."
New Treatment Options for Non-Small Cell Lung Cancer
Specializing in lung cancer at a major academic medical center, Nagla Karim, MD, PhD, sees many patients with adenocarcinoma non-small cell lung cancers, a cancer that begins in cells that line the lungs and that have gland-like (secretory) properties.
Current treatment for the disease consists of combination of platinum-based chemotherapy—but patient response to therapy is inconsistent. Using the drug pemetrexed in combination with cisplatin or carboplatin gave an improved outcome in patients with advanced adenocarcinoma of the lung, but some patients remain resistant or progress on this therapy. Despite advanced in therapy with the introduction of new therapies, the prognosis remains daunting with a 5 percent five-year survival in advanced lung cancer.
Previous laboratory studies have shown that over-expression of a certain cellular biomarker—known as steroid receptor coactivator-3 (SRC-3)—may play a role in the development and progression of many cancers, including non-small cell lung cancer.
Karim believes combining cytotoxic chemotherapy with a SRC-3 signaling pathway inhibiting drug could potentially improve the treatment of non-small cell lung cancer. Through the ASCO/AACR workshop, she will finalize design work on phase-1/2 study for patients to compare the effectiveness of established treatment lines for advanced lung cancer with standard therapy plus a SRC-inhibiting drug.
"What is exciting about this workshop is that we will have immediate access to all the experts we need to polish our idea. There will be several people with expertise in all aspects of clinical trials right there to put the protocol in place,” says Karim. "Having this intensive, one-week training experience will be very productive.
"I expect to have an investigator-initiated trial ready to implement when I get back. But I also expect to learn the techniques for developing these protocols so that it will take less time and help move important ideas into clinical trials.”
About the UC Cancer Institute and Cincinnati Cancer Center
TheUC Cancer Institute(UCCI) organizes all adult cancer patient care, research and education missions within the UC College of Medicine and throughout UC Health patient care settings. UCCI is part of the Cincinnati Cancer Center (CCC), a joint cancer program involving the UC College of Medicine, Cincinnati Children’s Hospital Medical Center and UC Health. The CCC collaborative initiative brings together interdisciplinary research teams of caring scientists and health professionals to research and develop new cures, while providing a continuum of care for children, adults and families with cancer.