STAT3 DECOY in Head and Neck Cancer

Plain-language summary

This study evaluated a treatment called STAT 3 DECOY in patients with head and neck squamous cell carcinoma that could be removed by surgery. It was open to adults aged 18 and older with a histologically confirmed diagnosis. Sponsored by the University of Pittsburgh, the study was conducted in Early Phase 1 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Early Phase 1

Status

Completed

Sponsor

University of Pittsburgh

Intervention

STAT 3 DECOY

Start date

8/1/2008

Estimated completion

8/1/2011

Countries

United States

Related genes

Locations

• Pittsburgh, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine 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