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Phase I/II Clinical Trial Will Assess Lung Cancer Vaccine

A phase I/II clinical trial being conducted at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland, will evaluate the side effects and optimal dose of an experimental lung cancer vaccine. The study will enroll patients with advanced recurrent or refractory non–small cell lung cancer.

Lung cancer remains the leading cause of cancer deaths in the United . Non–small cell lung cancer (NSCLC) accounts for approximately 75–80% of all lung cancers.

Advanced NSCLC refers to cancer that has spread from the lung to distant sites in the body. In order to improve survival and quality of life in patients with advanced NSCLC, researchers continue to explore new therapeutic approaches.

The current study will evaluate the use of an experimental lung cancer vaccine. The vaccine is intended to stimulate a patient’s immune system to attack tumor cells. If the vaccine is successful, it could cause cancer to shrink or to stabilize.

The study will enroll 52 patients with advanced NSCLC. Specific eligibility criteria are provided at the Web sites listed below.

The primary objectives of the study are to evaluate the safety of the vaccine and to determine the maximum tolerated dose. The researchers will also evaluate tumor and immunological response to the vaccine.

The study is being conducted at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland. The title of the study is “A Phase I/II Study of an Antitumor Vaccination Using α (1,3) Galactosyltransferase Expressing Allogeneic Tumor Cells in Patients With Refractory or Recurrent Non–Small Cell Lung Cancer (NCI-04-C-0049).”

Patients with lung cancer may wish to talk with their doctor about the risks and benefits of participating in this or other clinical trials.

For more information about this study, visit the following Web sites:

http://www.cancer.gov/search/ViewClinic ... 04-C-0049; http://bethesdatrials.cancer.gov/lung_c ... ci04c0049/.

To learn about other cancer clinical trials, visit www.cancer.gov or www.cancerconsultants.com.

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