STAT3 DECOY in Head and Neck Cancer - Full Text View

Sponsored by:	University of Pittsburgh
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00696176

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:

To assess the safety of a single dose of intratumoral STAT3 decoy.
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

MedlinePlus related topics: Cancer Head and Neck Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Active Control, Single Group Assignment, Safety Study
Official Title:	Preliminary Assessment of the Safety and Biological Activity of Intratumoral STAT3 DECOY in Surgically Resectable Head and Neck Squamous Cell Carcinoma

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 ]

Estimated Enrollment:	15
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental STAT 3 decoy administration	Drug: STAT 3 DECOY single administration to a head and neck tumor

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

Responsible Party:	Head and Neck Cancer Program - Department of Otolaryngology ( Jennifer Grandis )
Study ID Numbers:	UPCI 07-022
Study First Received:	June 10, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00696176
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:

STAT 3 DECOY

Study placed in the following topic categories:

Epidermoid carcinoma
Squamous cell carcinoma
Head and Neck Neoplasms

Carcinoma, squamous cell
Carcinoma, Squamous Cell
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009