Phase 0-1 Clinical Trials

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The collaboration between the DTB and DCTD has been responsible for the development of several new pharmacodynamic assays, including an ultrasensitive immunofluorescence assay for gamma H2AX (DNA double strand break detector) in tumor tissue biopsies, and ELISAs for topoisomerase I and poly ADP-ribose polymerase (PARP), as well as assays for other DNA damage markers (pNBS1), all of the isoforms of MEK, ERK, and AKT, DNMTs, as well as a series of immuno-PD markers. These assays have been essential for first in human clinical trials of novel non-camptothecin topoismerase I inhibitors, DNMT1 inibitors, and immunotherapy combinations that have been activated in the NIH Clinical Center. In addition, collaborations with the Pediatric Oncology Branch have facilitated the development of new agents used for rare tumors. Additional collaborations have developed around our use of the NCI 60 for systems pharmacology.