STAT3 DECOY in Head and Neck Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2008 |
| End Date: | August 2011 |
Preliminary Assessment of the Safety and Biological Activity of Intratumoral STAT3 DECOY in Surgically Resectable Head and Neck Squamous Cell Carcinoma
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.
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.
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, and as administered, will have no therapeutic or diagnostic intent. Rather,
the trial is designed to determine if intratumoral administration of the STAT3 decoy in
human head and neck tumors inhibits STAT3 target gene expression. Given the cumulative
evidence supporting STAT3 as a therapeutic target in cancer, and the absence of any clinical
trial to date using a STAT3 inhibitor, it was felt that there would be utility in a proof of
principal study to determine if the STAT3 decoy inhibits the expression of STAT3 target
genes in human head and neck cancers. To support the proposed study design, the Grandis lab
carried out a kinetic study in a xenograft model of SCCHN. Preliminary results demonstrated
that administration of the STAT3 decoy, but not the mutant control decoy, decreased
expression of STAT3 target genes (Bcl-xL and/or Cyclin D1) at time points ranging from 1 to
6 hours.
was based upon the expectation that the trial will involve very limited human exposure to
the STAT3 decoy, and as administered, will have no therapeutic or diagnostic intent. Rather,
the trial is designed to determine if intratumoral administration of the STAT3 decoy in
human head and neck tumors inhibits STAT3 target gene expression. Given the cumulative
evidence supporting STAT3 as a therapeutic target in cancer, and the absence of any clinical
trial to date using a STAT3 inhibitor, it was felt that there would be utility in a proof of
principal study to determine if the STAT3 decoy inhibits the expression of STAT3 target
genes in human head and neck cancers. To support the proposed study design, the Grandis lab
carried out a kinetic study in a xenograft model of SCCHN. Preliminary results demonstrated
that administration of the STAT3 decoy, but not the mutant control decoy, decreased
expression of STAT3 target genes (Bcl-xL and/or Cyclin D1) at time points ranging from 1 to
6 hours.
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
We found this trial at
1
site
5150 Centre Ave
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
(412) 647-2811
University of Pittsburgh Cancer Institute Founded in 1985, the University of Pittsburgh Cancer Institute (UPCI)...
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