A retroviral vector containing the wild-type p53 gene under control of
a p-actin promoter was produced to mediate transfer of wild-type p53
into human non-small cell lung cancers by direct injection. Nine patie
nts whose conventional treatments failed were entered into the study.
No clinically significant vector-related toxic effects were noted up t
o five months after treatment. In situ hybridization and DNA polymeras
e chain reaction showed vector-p53 sequences in posttreatment biopsies
. Apoptosis (programmed cell death) was more frequent in posttreatment
biopsies than in pretreatment biopsies. Tumor regression was noted in
three patients, and tumor growth stabilized in three other patients.