Biologic and Technical Considerations for the Design of Screening Procedures for the Assessment of Biological Response Modifiers

Abstract

In this chapter we present the rationale for the design of a meaningful test system for determining the potential value of biological response modifying agents for the treatment of cancer in general, and metastasis in particular. For the last two centuries, numerous efforts have focused on treating neoplastic diseases by the manipulation of the host with agents which we now classify as biological response modifiers (BRMs). An implicit assumption in these studies has been the belief that clinical cancer is the consequence of altered homeostasis, in which host responses to an oncogenic challenge are diminished or absent. Thus, it was reasoned that the successful awakening or boosting of a host’s response to neoplasia should lead to tumor regression. However, clinical immunotherapeutic trials with a variety of agents have yielded discouraging results that are greatly inferior to those obtained in various animal models.