Workshop Summary: Clinical Evaluation of Immunomodulating Agents in Cancer with Emphasis on New Approaches

Abstract

Clinical evaluation of immunomodulating agents is a new approach which should be considered separate from that associated with chemotherapeutic agents. A few very important points must be made concerting these new agents modulating the immune response in order to avoid mismanagement and fatal errors associated with their use To begin with, the agents should be chemically well defined compounds. Mixtures of complex molecules (for example BCG and Corynebacterium parvum) should be avoided. Chemically characterized drugs are a prerequisite for an accurate pharmacological profile concerning its metabolism in the body, the blood and urine. In our opinion, this approach is essential to be able to establish a correlation between drug blood levels and its effects on the immune response. The immunological target will also have to be identified in both animal models and in vitro in order to apply the best adapted and, the most significant in vivo tests to the human situation. It is essential to identify not only the immunological target cells, but also the target function(s). Criticism concerning the results presented for many immunomodulating agents has centered around the fact that no placebo was used. It is an accepted fact that the placebo effect can profoundly modify immune response in 30 to 40% of patients. We believe that this sort of control is essential to the evaluation of new immunomodulating agents. The last point which we wish to underline concerns the evaluation of side-effects vis a vis not only the immunological system but also different organ systems and their functions.