Status:
COMPLETED
STAT3 DECOY in Head and Neck Cancer
Lead Sponsor:
University of Pittsburgh
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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 ...
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, an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00696176
Start Date
August 1 2008
End Date
August 1 2011
Last Update
July 23 2015
Active Locations (1)
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1
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232