STAT3 DECOY in Head and Neck Cancer

NCT00696176 | Completed Early Phase 1 DMC

• 1 other identifier: 07-022
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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 rationale for targeting STAT3 using this approach is to decrease STAT3-mediated gene regulation. The study has the following scientific objectives:

1. 1.To assess the safety of a single dose of intratumoral STAT3 decoy.
2. 2.To estimate the effect of STAT3 decoy therapy on STAT3 activation levels, STAT3-mediated gene expression, and apoptosis in treated tumors.

Conditions

Head and Neck Cancer

Keywords

STAT 3 DECOY

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety of a single injection.

  pre and post surgery

Secondary Outcomes (1)

• Evaluate the biological activity by observing the consequences of STAT3 decoy administration on STAT3 activation and target gene expression in the tumor.

  pre and post surgery

Study Arms (1)

A

EXPERIMENTAL

STAT 3 decoy administration

Drug: STAT 3 DECOY

Interventions

STAT 3 DECOY DRUG

single administration to a head and neck tumor

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (1)

• Sen M, Thomas SM, Kim S, Yeh JI, Ferris RL, Johnson JT, Duvvuri U, Lee J, Sahu N, Joyce S, Freilino ML, Shi H, Li C, Ly D, Rapireddy S, Etter JP, Li PK, Wang L, Chiosea S, Seethala RR, Gooding WE, Chen X, Kaminski N, Pandit K, Johnson DE, Grandis JR. First-in-human trial of a STAT3 decoy oligonucleotide in head and neck tumors: implications for cancer therapy. Cancer Discov. 2012 Aug;2(8):694-705. doi: 10.1158/2159-8290.CD-12-0191. Epub 2012 Jun 20.

  PMID: 22719020 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Jennifer Grandis, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2008
• First Posted: June 12, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: July 23, 2015

Record last verified: 2012-09

Locations

US (1)