Head and Neck Cancer Clinical Trial
Official title:
Preliminary Assessment of the Safety and Biological Activity of Intratumoral STAT3 DECOY in Surgically Resectable Head and Neck Squamous Cell Carcinoma
Verified date | September 2012 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | August 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the safety of a single injection. | pre and post surgery | Yes | |
Secondary | Evaluate the biological activity by observing the consequences of STAT3 decoy administration on STAT3 activation and target gene expression in the tumor. | pre and post surgery | No |
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