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.
D001688:Biological Products / Q000627:therapeutic use*; D002266:Carboxymethylcellulose Sodium / Q000627:therapeutic use / Q000031:analogs & derivatives; D004341:Drug Evaluation; D006801:Humans; D007370:Interferon Type I / Q000627:therapeutic use; D007371:Interferon-gamma / Q000627:therapeutic use; D009369:Neoplasms / Q000188:drug therapy / Q000628:therapy*; D011070:Poly I-C / Q000627:therapeutic use; D011107:Polylysine / Q000627:therapeutic use / Q000031:analogs & derivatives; D013947:Thymosin / Q000627:therapeutic use
D001688:Biological Products; D007370:Interferon Type I; D011107:Polylysine; D013947:Thymosin; C019531:poly ICLC; D007371:Interferon-gamma; D002266:Carboxymethylcellulose Sodium; D011070:Poly I-C