Background. Molecular or gene therapy involves the introduction of gen
etic material (DNA) into host cells to induce the expression of the th
erapeutic product of that gene. This ability to transfer genetic mater
ial provides a novel approach for the investigation and potential trea
tment of a variety of both inherited and acquired diseases. Methods. T
his review summarizes the principles of molecular therapy and potentia
l strategies for its use in the treatment of solid malignancies. Some
molecular therapy strategies permanently integrate the gene into the t
argeted cells, whereas others induce only transient expression of a th
erapeutic gene product. Initial clinical studies in gene therapy are b
eing closely regulated for public safety by both the National Institut
es of Health Recombinant DNA Advisory Committee and the U.S. Food and
Drug Administration. Conclusions. These studies will provide insight i
nto further applications of gene therapy and novel molecular intervent
ions that may alter our management of solid malignancies; they may als
o reveal mechanisms for preventing or reversing the carcinogenic proce
ss. (C) 1995 John Wiley & Sons, Inc.