STAT3 DECOY in Head and Neck Cancer
Completed · Early Phase 1
Conditions studied: Head and Neck Cancer
In brief
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.
Key facts
- Study ID
- NCT00696176
- Run by
- University of Pittsburgh
- People needed
- 32
- Starts
- 2008-08-01
- Expected to finish
- 2011-08-01
- Last updated by the study team
- 2015-07-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University of Pittsburgh Cancer Institute — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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