"Therapeutic Vaccine Clinical trial Available at Unn. K

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"Therapeutic Vaccine" Could Improve Quality of Life for People with Lung Cancer

Media Contact: Hollye Staley, (859) 323-6363

LEXINGTON, Ky. (Aug. 16, 2006) − For the past four years, researchers at the University of Kentucky have been working on a "therapeutic vaccine" to prevent lung cancer from recurring in people who have already had traditional treatments such as surgery and chemotherapy. Their goal is to reduce the chance of the cancer coming back – something that happens in 30 to 50 percent of lung cancer patients.

Even with the advancements in lung cancer treatment over the past 30 years, the outcome of the disease sadly remains the same. In Kentucky, more than 3,000 people die of lung cancer each year, and at a much higher rate than any other state.

"For a state that has such a devastating problem, having the opportunity to do this research here is really important," said Dr. Edward A. Hirschowitz, the project's principal investigator.

The vaccine is now in its second phase of study and is enrolling participants in Kentucky. Lung cancer patients meeting the study's criteria are now eligible to participate at the Commonwealth Cancer Center location in Danville and at Owensboro Medical HealthCare System's Mitchell Memorial Cancer Center in Owensboro. Dr. Dattatraya Prajapati and Dr. Thomas Baeker are the leading investigators in Owensboro and Danville, respectively. Study participants can be from anywhere in Kentucky as long as they are able to make eight trips over a year to receive the vaccine and follow-up care.

"These sites were chosen because we are interested in community-based research and they are a part of the Kentucky Clinical Trials Network," Hirschowitz said. The network is part of the Kentucky Lung Cancer Research Program, and is a collaboration between the University of Kentucky and the University of Louisville.

Kris Damron, program manager for the Kentucky Clinical Trials Network, said these sites were selected based on their previous experience in conducting clinical research complying with federal guidelines applicable to investigational new drugs, such as the lung cancer vaccine. Both sites are strongly committed to providing the best clinical care to their patients.

"All members of the Kentucky Clinical Trials Network are working to provide Kentuckians the opportunity to receive innovative cancer care through participation in clinical trials," Damron said. "The network applies scrupulous quality assurance and ethical research principles to further the improvement of cancer therapies."

For this part of the study, the researchers hope to treat about 12 patients with stage I or stage II non-small cell lung cancer, and expect to have results six months after the first vaccine is given. Each patient will receive two injections of the vaccine. The first injection will be given at least four weeks after surgery, and the second injection will be given four weeks later. The hope is that the vaccine will trigger the person's immune system to recognize and destroy any cancer cells that may not have been removed from previous surgery and chemotherapy treatments.

"Because additional medical therapies are not generally recommended until recurrences are seen, we are using the window between traditional medical or surgical therapy and recurrence to enhance the immune response to any remaining cancer," Hirschowitz said. At this point in the project, Hirschowitz and his research partner John Yannelli know they may not be looking at a cure, but at the potential to prolong health.

"In this pilot study we are specifically looking at whether this vaccine is biologically active and can induce an immune response against cancer cells," Hirschowitz said. "If it performs as we anticipate, we will be conducting a larger randomized trial to determine whether the vaccine can impact a person's survival."

Hirschowitz anticipates that the larger phase III clinical trial could start as soon as next spring. It will take about three to five years to study all the information gathered from this phase, he said. The ultimate goal is to get a vaccine that can be given in any doctor's office that can improve a person's survival of lung caner.

Hirschowitz, an associate professor of medicine, and Yannelli, an associate professor in the Department of Microbiology, both in the UK College of Medicine, hope their research will positively affect the prognosis of lung cancer patients in the future.

"Kentucky has such a devastating problem, developing vaccines research here is really important," Hirschowitz said. "A seemingly endless stream of lung cancer patients seen in our clinics continually reinforces the importance of this research.

Anyone interested in participating in the clinical trial should contact Celia Love with the UK Markey Cancer Center at (859) 323-1671.