This study will evaluate the effect of a specially tailored vaccine to treat patients with non-small cell lung cancer. About 50 to 60 percent of patients with this type of cancer have a defective gene called p53, which produces a protein that protects their tumor from attack by the immune system. The vaccine is designed to stimulate the immune system to recognize the tumor cells and kill them.
The faulty p53 gene can cause various types of abnormalities that result in runaway growth of cancer cells. Each patient's vaccine will be custom matched to their specific p53 abnormality. After completing standard treatment--which may include chemotherapy, radiation and surgery--patients will be infused with the vaccine once a week for five weeks. Patients whose tumors respond to the treatment may receive additional vaccinations at two-month intervals for as long as they continue to benefit. In a previous small study, five out of five patients showed an immune response to p53 peptide vaccination.
Candidates for the study will be screened with a medical history, blood and urine tests and imaging studies (X rays and CT scans). A tumor sample will also be taken to see if it has a p53 abnormality suitable for this study. Study patients will undergo apheresis-a procedure to collect white blood cells needed to make their vaccine. In apheresis, blood is drawn through a needle in one arm, similar to donating blood. The blood goes through a machine that separates out some of the white cells, and the rest of the blood is returned, usually through a needle in the other arm. Patients will also have additional physical exams, blood tests, and imaging studies during the course of the study to evaluate the effects of treatment.
http://www.clinicaltrials.gov/ct/gui/sh ... 2F?order=3