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STAT3 DECOY in Head and Neck Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00696176
First received: June 10, 2008
Last updated: September 5, 2012
Last verified: September 2012
History of Changes
  Purpose

The primary goal of this study is to evaluate the safety of a transcription factor decoy targeting Signal Transducer and Activator of Transcription 3(STAT3) in patients with head and neck cancer. The rationale for targeting STAT3 using this approach is to decrease STAT3-mediated gene regulation. The study has the following scientific objectives:

  1. To assess the safety of a single dose of intratumoral STAT3 decoy.
  2. To estimate the effect of STAT3 decoy therapy on STAT3 activation levels, STAT3-mediated gene expression, and apoptosis in treated tumors.

Condition Intervention Phase
Head and Neck Cancer
 Drug: STAT 3 DECOY
 Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Preliminary Assessment of the Safety and Biological Activity of Intratumoral STAT3 DECOY in Surgically Resectable Head and Neck Squamous Cell Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Evaluate the safety of a single injection. [ Time Frame: pre and post surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate the biological activity by observing the consequences of STAT3 decoy administration on STAT3 activation and target gene expression in the tumor. [ Time Frame: pre and post surgery ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: August 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
STAT 3 decoy administration
 Drug: STAT 3 DECOY
single administration to a head and neck tumor
Other Name: STAT 3 DECOY

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696176

Locations
United States, Pennsylvania
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Jennifer Grandis, MD University of Pittsburgh
  More Information

No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00696176     History of Changes
Other Study ID Numbers: 07-022
Study First Received: June 10, 2008
Last Updated: September 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
STAT 3 DECOY

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on May 16, 2013