) This project, now in its 37th year is this Institution's major vehicle for translating Sloan-Kettering Institute developed chemicals and biologicals into clinical studies. The program has three major themes: (1) Novel strategies and new drug development, (2) Targeted therapies that include biological (vaccines, antibodies) and histone deacetylase (HDAC), inhibitors, and (3) Development of end points and prognostic correlation models for response and outcome. To accomplish these goals, we have organized the program in accord with the manner in which new treatments progress from the laboratory to the clinic, i.e., via Phase I studies (Project 0143), to phase II studies in both hematologic (Project 0150) and solid tumor malignancies (Project 0154). These projects are supported by three cores: An Biostatistics Core, that provides biostatistical input into protocol design and outcome analysis, and a Pharmacology Core, that generates assays for new drug trials, and pharmacokinetic measurement. Progress toward the goals of this program, namely improved cancer treatments, is facilitated by the interaction between laboratory and clinical investigators, thus providing feedback and biologic correlates, as well as with other investigators in the departments of Surgery and Radiotherapy.
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