New Vaccine for Advanced Non-Small Cell Lung Cancer
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.
Principal Investigator
 |
Dr. John C. Morris Principal Investigator |
Dr. John C. Morris, NCI Center for Cancer Research.
Why This Trial Is 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 system of NSCLC patients to attack their tumors. The vaccine consists of killed human NSCLC cells that have been genetically altered to express a non-human 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 stablization."
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.
Study Site and Contact Information
The study is taking place at the NIH Clinical Center in Bethesda, Maryland. For more information, contact the NCI Clinical Studies Support Center at 1-888-NCI-1937. The toll-free call is confidential.
Published Results
Morris JC, Janik JE, Vahanian N, et al.: A phase I study of antitumor vaccination using genetically modified tumor cells expressing (1,3) galactosyltransferase in patients with refractory or recurrent non-small cell lung cancer (NSCLC): preliminary results. [Abstract] American Society of Gene Therapy: 8th Annual Meeting, 1-5 June, 2005, St. Louis, MO. A-1133, 2005.
Morris JC, Vahanian N, Janik JE, et al.: Phase I study of an antitumor vaccination using a(1,3) galactosyltransferase expressing allogeneic tumor cells in patients (Pts) with refractory or recurrent non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 23 (Suppl 16): A-2586, 187s, 2005.
