STAT3 DECOY in Head and Neck Cancer
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ClinicalTrials.gov Identifier: NCT00696176 |
Recruitment Status :
Completed
First Posted : June 12, 2008
Last Update Posted : July 23, 2015
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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:
- To assess the safety of a single dose of intratumoral STAT3 decoy.
- To estimate the effect of STAT3 decoy therapy on STAT3 activation levels, STAT3-mediated gene expression, and apoptosis in treated tumors.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Head and Neck Cancer | Drug: STAT 3 DECOY | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Preliminary Assessment of the Safety and Biological Activity of Intratumoral STAT3 DECOY in Surgically Resectable Head and Neck Squamous Cell Carcinoma |
Study Start Date : | August 2008 |
Actual Primary Completion Date : | August 2011 |
Actual Study Completion Date : | August 2011 |
Arm | Intervention/treatment |
---|---|
Experimental: A
STAT 3 decoy administration
|
Drug: STAT 3 DECOY
single administration to a head and neck tumor |
- Evaluate the safety of a single injection. [ Time Frame: pre and post surgery ]
- Evaluate the biological activity by observing the consequences of STAT3 decoy administration on STAT3 activation and target gene expression in the tumor. [ Time Frame: pre and post surgery ]
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696176
United States, Pennsylvania | |
University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15232 |
Principal Investigator: | Jennifer Grandis, MD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00696176 |
Other Study ID Numbers: |
07-022 |
First Posted: | June 12, 2008 Key Record Dates |
Last Update Posted: | July 23, 2015 |
Last Verified: | September 2012 |
STAT 3 DECOY |
Head and Neck Neoplasms Neoplasms by Site Neoplasms |