Name of the Trial
Phase I/II Study of Antitumor Vaccination Using alpha-1,3-Galactosyltransferase-Expressing Allogeneic Tumor Cells (HyperAcute Lung Cancer Vaccine) in Patients with Advanced, Refractory, or Recurrent Non-Small-Cell Lung Cancer (NCI-04-C0049). See the protocol summary at http://cancer.gov/clinicaltrials/NCI-04-C-0049.

Principal Investigator
Dr. John C. Morris, NCI Center for Cancer Research

Why Is This Trial Important?
Lung cancer is the leading cause of cancer-related death in the United States, with more than 163,000 people expected to die from the disease in 2005.

Lung cancer is most often diagnosed at advanced stages when it is difficult to treat. About 80 percent of non-small-cell lung cancer (NSCLC) cases are detected when they have progressed to stages III or IV, and life expectancy ranges from 6 to 12 months.

Researchers are testing a vaccine intended to stimulate the immune systems of NSCLC patients to attack their tumors. The vaccine consists of killed human NSCLC cells that have been genetically altered to express a nonhuman carbohydrate on their surface. This carbohydrate, known as alpha-Gal, is present in lower animals, but not in humans. Alpha-Gal is a powerful antigen that causes a rapid, hyperacute antibody response whenever foreign tissues bearing it are introduced into the human body. The response is powerful enough to destroy transplanted cells and tissues within hours.

Athough cells making up naturally occuring NSCLC tumors in patients do not express alpha-Gal, they share other cell-surface molecules with the genetically altered NSCLC cells introduced by the vaccine. The researchers hope those similarities will allow the antibodies and immune cells targeting alpha-Gal to redirect their attack and destroy patients' own tumor cells.

"Until this trial, this type of vaccine had never been tested in patients," said Dr. Morris. "If it works, it may lead to tumor shrinkage or disease stabilization."

Who Can Join This Trial?
The researchers will recruit 52 patients aged 18 and over who have been diagnosed with advanced NSCLC. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/NCI-04-C-0049.

Where Is This Trial Taking Place?
The study is taking place at the National Institutes of Health Clinical Center in Bethesda, Md.

Contact Information
For more information, contact the NCI Clinical Studies Support Center at 1-888-NCI-1937. The toll-free call is confidential.