Methods for evaluating biological response modifiers

Biological response modifiers (BRM) are a new approach of cancer treatment The guidelines for their evaluation are comparable to those used for evalua ting conventional anticancer treatments However it is more difficult to ass ess their efficacy and toxicity because of their own properties and of the characteristics of underlying diseases. The objectives of studying BRM effi cacy are the following: 1- to confirm the pharmacodynamic effect observed i n experimental models 2- to assess the benefit for the patient Phase IT stu dies can occasionally be performed in healthy volunteers. Efficacy criteria are objective response rate, progression free survival overall survival or , for hematopoietic growth factors, more specific criteria. In randomized p hase III studies patients in the control arm can be observed without treatm ent or receive a placebo or a standard treatment. Rr regards toxicity, side effects specifically related to the use of BRM are the synthesis of cytoki nes, the stimulation of immune system, the stimulation of tumor growth, the synthesis of anti-mouse of anti-BRM antobodies.