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Pathways to Discovery: Summer 2011

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Conversation, Targeted Approach May Increase Clinical Trial Enrollment

We have to be innovative and balance science and practicality.
Walter Stadler, MD

When the National Cancer Act was signed 40 years ago, scientists had just a basic understanding of the origins and progression of cancer. Today, through the use of new tools and technologies, massive computing power, and insights from other fields, we know that cancer is a complex set of diseases that can be controlled in many different ways. We also know that advances against cancer depend on science of many kinds.

Clinical trials are part of the process of developing new treatments. The University of Chicago has the largest cancer clinical trials program in Illinois, leads several national clinical trials study groups, and is one of only a handful of hospitals in the country that provides all three phases of clinical trials through programs funded by the National Cancer Institute.

Yet, barriers remain to expeditiously develop and implement treatment protocols so that new therapies can become standard practice. Some of those barriers include decreased funding, increased regulatory burdens, and difficulty accruing patients.

“I think we have to be innovative and balance science and practicality,” said Walter M. Stadler, MD, Fred C. Buffett Professor of Medicine and Surgery and director of the UCCCC’s Phase II Clinical Trials Network. “I think this is solvable.”

Dr. Stadler welcomed more than 50 researchers and clinical data managers from six states to a Phase II Clinical Trials Symposium held at UChicago’s Knapp Center for Biomedical Discovery in April. Phase II trials pick up where Phase I trials leave off in testing the safety of a drug or procedure. The difference is that Phase II trials are open to a larger group of patients, tend to focus on a particular type of cancer, and begin to evaluate how well a new drug or procedure works.

New Therapies
Having frank conversations with patients may be a key to improving patient accrual. A 2003 study in the Journal of Clinical Oncology found that only 3% to 5% of adult cancer patients enroll in clinical trials, even though many indicate an interest in doing so if asked.

“Talk with your patients,” said Victoria Villaflor, MD, assistant professor of medicine. “I try to explain to my patients that trials will help them to help the future of their disease. I also explain that personalized therapies for some cancers are currently available because of clinical trials.”

Richard Schilsky, MD, professor of medicine and co-deputy director of the UCCCC, said that molecular medicine will likely increase clinical trial enrollment and decrease the time needed to complete the studies. “The use of biomarkers to identify patients likely to respond to the treatment being tested offers the potential for higher effect sizes in clinical trials,” Dr. Schilsky wrote in a commentary in the March 23, 2011, issue of Science Translational Medicine.

Progress in the Treatment of Pancreatic Cancer
Throughout the daylong symposium, speakers discussed progress in open clinical trials and hypotheses for new clinical trials. Among those presenting was Hedy Lee Kindler, MD, associate professor of medicine, who discussed progress in treatment for pancreatic cancer—a cancer that has a 5-year survival rate of only 6%, according to the American Cancer Society.

“This cancer has the worst survival of any solid tumor,” said Dr. Kindler. “These dismal statistics reflect not only the early distant spread of pancreatic cancer, but also the inadequacy of current therapies.”

She explained that it has been difficult to develop drugs to effectively treat pancreatic cancer because it is a highly lethal disease that is usually detected late, is very resistant to most agents, and has poorly understood biology.

“We are now testing two new novel targets—Hedgehog signaling and notch signaling—in Phase II consortium trials,” she said. Inhibiting hedgehog signaling appears to enhance delivery of chemotherapy, while inhibiting notch signaling may decrease tumor growth.

Dr. Kindler said she is hopeful that enough patients will enroll in these studies so that new therapies can be developed.

CLOCK Program
In addition to leading national clinical trials and mentoring dozens of researchers, the UCCCC is helping to speed the clinical trials process through its new CLOCK program. CLOCK stands for Clinical Trial Operational Efficiency via Computer-aided Knowledge. The program defines and standardizes the process across multiple treatment sites, utilizes project management and measurement tools, and develops analytical reports and action triggers that will help optimize the process.

Currently, the UCCCC has more than 350 open cancer clinical trials.