STAT3 DECOY in Head and Neck Cancer

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh

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