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Preliminary Assessment of the Safety and Biological Activity of Intratumoral STAT3 DECOY in Surgically Resectable Head and Neck Squamous Cell Carcinoma

Phase 0
18 Years
Not Enrolling
Head and Neck Cancer

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Trial Information

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.

Inclusion Criteria:

- Histologically confirmed diagnosis of head and neck squamous cell carcinoma(primary
or recurrent) amenable to surgical resection.

- ECOG performance status of 0, 1, or 2.

- Adequate organ function

- Age greater than or equal to 18 years

- Written informed consent.

- Patients with second primary lesions will be eligible for this trial.

- Negative pregnancy test, nonlactating, and using effective means of contraception if
childbearing potential.

Exclusion Criteria:

- Subjects who fail to meet the above criteria.

- Subjects who are pregnant.

- Subjects with an ECOG performance status >2.

- Subjects with tumors that are too small to biopsy prior to resection and reserve a
portion of the resected specimen for research purposes.

- Subjects who receive neoadjuvant radiotherapy and/or chemotherapy within four week
prior to enrollment

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Evaluate the safety of a single injection.

Outcome Time Frame:

pre and post surgery

Safety Issue:


Principal Investigator

Jennifer Grandis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Food and Drug Administration

Study ID:




Start Date:

August 2008

Completion Date:

August 2011

Related Keywords:

  • Head and Neck Cancer
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213