Having demonstrated the feasibility of the capillary tumor clonogenic cell assay in Phase I, the initial effort of the Phase II contract will be the optimization and evaluation of this system, the application of this assay to the study of the growth kinetics of colonies grown in the capillary tubes, the feasibility of a radioisotope endpoint for this system, and the determination of the stability of selected anti-cancer drugs - under the assay conditions - in this system. This having been accomplished, in collaboration with consultants, this system will be used in a prospective clinical correlation of patients' response to chemotherapy and the in vitro sensitivity of their tumors as determine by this assay. Patients entered into this study will be followed for a period of two years - by the consultants - in order to evaluate the predictability of this assay with the selection of the anti-neoplastic agent and patient response. Finally, the application of this assay as a tool for the screening of potential new anti-neoplastic agents will be studied.
