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Mayo Clinic chosen to coordinate cancer prevention clinical trials

Thursday, April 01, 2004

Mayo Clinic is one of six cancer research centers in the United States chosen by the National Cancer Institute (NCI) to participate in a new initiative to test the effectiveness of experimental medications and nutritional compounds for prevention of cancer.

The initiative represents a new approach by NCI's Division of Cancer Prevention to combat cancer. Each of the six cancer centers will design and lead clinical trials, coordinating its own network of health-care institutions to conduct the trials. The NCI has awarded more than $42 million in contracts to this six-member group. Mayo Clinic's contract amounts to $9.3 million.

Dr. Edith Perez, an oncologist at Mayo Clinic in Jacksonville, is one of the program directors for the consortium and a member of the steering committee that will select which proposals submitted for study are worthy to take to clinical trial. "The NCI and all of us at Mayo feel cancer has to be tackled in three ways," she says. "We need to understand the biology of cancer. We need to treat patients who are already diagnosed with the disease, and we need to figure out ways to alleviate the burden of cancer through prevention."

Dr. Paul Limburg, a gastroenterologist at Mayo Clinic in Rochester, Minn., specializes in cancer prevention. Limburg is the principal investigator for the Mayo Clinic clinical trials network. He says there are plans to conduct early phase clinical trials for up to seven types of cancer ¾ colorectal, breast, esophageal, liver, blood system, urinary tract and lung ¾ over the next three to five years. "Our goal will be to find out whether the new agents tested can interrupt the process of cancer by stopping abnormal cells from becoming malignant."

Perez says one of the challenges in designing prevention trials is selecting agents that potentially decrease the risk of cancer that are non-toxic. This is important because they will be given to large numbers of healthy people over a long period of time. "In treatment protocols we know if something works in a year or two years," she says. "With prevention strategies, it may take years to get the results."

Dr. Timothy Woodward, a gastroenterologist at Mayo Clinic in Jacksonville specializing in gastrointestinal malignancies, is a co-investigator for planned colorectal trials. He says the strength of this NCI initiative is its scale. "There've been innumerable single-center trials giving us data to select which agents to look at in the first place," he says. "The problem in single-center trials is their size. You can't accumulate numbers like you do in a multi-center trial, and you might have a skewed population that isn't representative of the country in general."

Mayo Clinic will coordinate the cancer prevention clinical trials at 27 health-care institutions located throughout the United States and Canada. Approximately 100 patients will participate in each cancer prevention trial.

In addition to Mayo Clinic, NCI-designated cancer centers in Arizona, California, Illinois, Texas and Wisconsin are designing and coordinating cancer prevention trials.

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