Phase I trials of biological response modifiers.

An analysis of recently conducted phase I trials of biological response modifiers (BRM), performed mainly under the sponsorship of the BRM Program of the National Cancer Institute, has led to the development of a format for performing such trials with these agents in the future. The evolution of this format and its use in ongoing phase I trials of recombinant beta and gamma interferons is discussed. An evaluation of the method will be undertaken at the conclusion of these studies.