Assessment of biological responses: what to measure and when.
During the past several years, increasing attention has been devoted to the use of biological response modifiers (BRMs) for the treatment of cancer. Phase I trials of BRMs must be designed to provide information not only regarding toxic effects, pharmacokinetics, and antitumor activities, but also on the many immunomodulatory effects. Biological monitoring must be carefully planned to enable meaningful conclusions to be drawn as to the optimal dose, schedule, and route of administration. Important considerations include selection of assays for the various biological effects, timing of testing following BRM administration, and methods for data interpretations.
D000818:Animals; D001688:Biological Products / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000592:standards*; D003115:Colony-Stimulating Factors / Q000276:immunology; D004306:Dose-Response Relationship, Immunologic; D006801:Humans; D007121:Immunocompetence / Q000187:drug effects; D007158:Immunologic Techniques; D007167:Immunotherapy; D051379:Mice; D009369:Neoplasms / Q000276:immunology / Q000628:therapy*; D012107:Research Design / Q000592:standards
D001688:Biological Products; D003115:Colony-Stimulating Factors