Preliminary Assessment of the Safety and Biological Activity of Intratumoral STAT3 DECOY in Surgically Resectable Head and Neck Squamous Cell Carcinoma
The decision to proceed with an exploratory IND study to be conducted in a phase 0 setting
was based upon the expectation that the trial will involve very limited human exposure to
the STAT3 decoy, and as administered, will have no therapeutic or diagnostic intent. Rather,
the trial is designed to determine if intratumoral administration of the STAT3 decoy in
human head and neck tumors inhibits STAT3 target gene expression. Given the cumulative
evidence supporting STAT3 as a therapeutic target in cancer, and the absence of any clinical
trial to date using a STAT3 inhibitor, it was felt that there would be utility in a proof of
principal study to determine if the STAT3 decoy inhibits the expression of STAT3 target
genes in human head and neck cancers. To support the proposed study design, the Grandis lab
carried out a kinetic study in a xenograft model of SCCHN. Preliminary results demonstrated
that administration of the STAT3 decoy, but not the mutant control decoy, decreased
expression of STAT3 target genes (Bcl-xL and/or Cyclin D1) at time points ranging from 1 to
6 hours.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Evaluate the safety of a single injection.
pre and post surgery
Yes
Jennifer Grandis, MD
Principal Investigator
University of Pittsburgh
United States: Food and Drug Administration
07-022
NCT00696176
August 2008
August 2011
Name | Location |
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University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |