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Illustration of lungsClinical Trials: Lung Cancer

by Jeff Worley

The headlines blared WE'RE NUMBER 1! The news being trumpeted wasn't in the sports section. This wasn't about Kentucky basketball. It was about the latest lung-cancer rates in the United States, and the bad—but not surprising—news was that Kentucky's 1999 lung cancer numbers led the nation among men and women.

"Kentucky stands out not only as the number one state, but it's been that way for a long time," says Timothy Mullett, a lung surgeon and director of the University of Kentucky's Multidisciplinary Lung Cancer Program. This year it's estimated that 3,100 Kentuckians will die of lung cancer. "There's about 50 percent more lung cancer in Kentucky than the national average," says Alfred Cohen, director of UK's Markey Cancer Center. "That's catastrophic."

The disease kills 75 to 80 percent of those it infects. According to the American Cancer Society, this year more people will die from lung cancer than from breast, prostate and colorectal cancers combined.

Two UK researchers are working to reverse these stats with a novel vaccine they created to reduce the risk of lung cancer recurrence. John Yannelli, an associate professor of medicine, and Edward Hirschowitz, an assistant professor of medicine, are heading up a two-year clinical trial that will involve up to 30 patients diagnosed with non-small lung cancer who have already undergone surgery, radiation or chemotherapy. Non-small lung cancer is moderately fast-growing and best treated by surgical resection, and according to Hirschowitz, accounts for 75 percent of all diagnosed lung cancers. The trial is being funded by the Kentucky Lung Cancer Tobacco Settlement Fund and the Cancer Treatment Research Foundation, a national philanthropic agency based in Chicago.

"Although the vaccine will not prevent lung cancer in those who have never had it, we're hoping that it can prevent the disease from returning and help maintain remission periods after treatment," Hirschowitz says, as reported in the Lexington Herald-Leader last June, adding that even after lung cancer surgery that is deemed "successful," patients have a 15 to 50 percent chance of recurrence. "Because additional medical therapies are not generally recommended until recurrences are seen, we are using the window between medical and surgical therapy and recurrence to enhance the body's immune response to residual cancer."

Hirschowitz and Yannelli, with the aid of what Yannelli calls a "very talented and indispensable" support staff, make this vaccine in an eight-step process. First, through a procedure called leukapheresis, the patient's dendritic cells—the most potent immune-inducing cells in the body—are taken. Technicians duplicate them in the lab and mix them with cancer proteins derived from lung cancer cells. Once the dendritic cells ingest the lung cancer proteins, they are retrained to direct the immune system to target and kill cancer cells.

Photo of John Yannelli and Edward HirschowitzJohn Yannelli (foreground) and Edward Hirschowitz have created a novel vaccine to reduce the risk of lung cancer recurrence. Kentucky's 1999 lung cancer rates were the highest in the nation among men and women.

"This process takes seven days," Yannelli explains. "We've grown the number of cells up to very large numbers: at seven days we harvest a hundred million dendritic cells." The researchers put the cells, which are now in full combat gear, in an injectable saline solution, the vaccine.

"The beauty of this vaccine," Yannelli says, "is that it stimulates cells to attack only tumor cells. It does not attack normal tissue as past treatments have. These cells that we create are very, very smart."

Each patient receives two three-milliliter injections of the dendritic cells, one month apart. The researchers think that when the cells are delivered to the patient, they will travel to the lymph nodes and stimulate the immune system to seek and destroy cancer cells. "We don't know everything about the immune system, but we're taking advantage of what we do understand, letting the biology take care of business in reacting to an infection or other foreign proteins," Hirschowitz says.

There have been no major side effects from the injection so far in the trial, Yannelli says, only local reactions such as a small welt similar to what any of us might see after an allergy shot.

"We're doing something during a time when nothing else is offered," Hirschowitz says. "You can either sit on the couch waiting for your cancer to grow, or you can try something."

"Lung cancer is particularly aggressive," adds Yannelli. "We expect a recurrence—if there is one—to happen within three years. If someone doesn't have a recurrence in five years, they're cured. My fondest hope is to see my patients back in the clinic in five years and say—as they leave the room—'See you at the UK game.'"

For information on how to participate in this clinical trial, call the Pulmonary Research Office at 859/257-9575.

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