NOVEL THERAPEUTICS

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The Novel Therapeutics Committee of the North Central Cancer Treatment Group is a new committee designed to facilitate and coordinate the introduction of novel therapeutic approaches and predictors of response and toxicity into disease site programs of the NCCTG. The charge of the committee is to promote the development of novel therapeutic studies into the research programs of the NCCTG through interaction with the Mayo Clinic Cancer Center programs and programs at other organizations. The specific goals of the committee are: 1. To advice and facilitate development of selected phase Ib/II clinical trials. These trials could include combinations of novel agents with standard drugs or combinations of approved drugs. 2. To develop selected pharmacokinetic drug studies, such as population- based pharmacokinetics, testing of limited sampling models, drug disposition in organ dysfunction, and drug pharmacokinetics/pharmacodynamics in the elderly in collaboration with the disease site committees of the NCCTG. 3. To evaluate novel markers of response and toxicity that have been identified in research programs of the Mayo Clinic Cancer Center and other organizations. Such markers would be selected in discussions with the Laboratory Science Committee and specific disease site chairs. The significance of the work proposed is that the studies will build a logical progression from the laboratory through phase I into phase II evaluation. The phase II evaluation is critical to the confirmation of the mechanisms which have been delineated in the preclinical models using biomarkers that have been identified as potentially feasible to apply in broader clinical testing during phase I testing. Previous work that has already been undertaken and proposed projects are detailed in the report that follows.