Trial Information

Molecular, Genetic, and Biochemical Effects Of Novel Therapies In Buccal Mucosal Cells

A significant problem in drug development of novel small molecules is the lack of available
tissues (surrogate tissues) that allow for the assessment of the molecular and biochemical
effects of (targeted-therapies) drug action. The information obtained from surrogate
tissues might help us validate previous preclinical studies with those agents and also dose
them in a more rational way. Oral keratinocytes, which are accessible by non-invasive
means, might be useful to assess drug action. The proposed study seeks to investigate the
genetic, molecular, and biochemical effects of novel agents in oral buccal mucosal cells.
Patients already enrolled in Phase I and II clinical trials for neoplastic diseases at the
Clinical Center will undergo oral cytobrushing before and during therapy to determine the
molecular and biochemical effects of novel agents in the oral mucosa cells. Similar studies
will be performed in peripheral blood mononuclear cells. In order to validate to compare
and compare the oral cytobrush methodology, some of these subjects will undergo oral punch
biopsy studies. Some of these subjects will also undergo tumor biopsy, if accessible or
available.