Pilot Study of Metformin in Head and Neck Squamous Cell Cancer and Its Effects on Stromal-epithelial Metabolic Uncoupling | RxWiki

Pilot Study of Metformin in Head and Neck Squamous Cell Cancer and Its Effects on Stromal-epithelial Metabolic Uncoupling

Overview[ - collapse ][ - ]

Purpose	The purpose of this study is to assess the effect of metformin in tumor metabolism in patients with head and neck cancer by evaluating metformin's ability to decrease TOMM20 expression in squamous carcinoma cells and decrease MCT4 expression in fibroblasts.
Condition	Head and Neck Squamous Cell Cancer
Intervention	Drug: Metformin
Phase	Phase 0
Sponsor	Thomas Jefferson University
Responsible Party	Thomas Jefferson University
ClinicalTrials.gov Identifier	NCT02083692
First Received	March 4, 2014
Last Updated	March 6, 2014
Last verified	March 2014

Tracking Information[ + expand ][ + ]

First Received Date	March 4, 2014
Last Updated Date	March 6, 2014
Start Date	September 2013
Estimated Primary Completion Date	Not Provided
Current Primary Outcome Measures	Change in TOMM20 and MCT4 expression from tumor cells from date of biopsy and date of surgery [Time Frame: date of biopsy and date of surgery (9-28 days)] [Designated as safety issue: No]
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Pilot Study of Metformin in Head and Neck Squamous Cell Cancer and Its Effects on Stromal-epithelial Metabolic Uncoupling
Official Title	Pilot Study of Metformin in Head and Neck Squamous Cell Cancer and Its Effects on Stromal-epithelial Metabolic Uncoupling.
Brief Summary	The purpose of this study is to assess the effect of metformin in tumor metabolism in patients with head and neck cancer by evaluating metformin's ability to decrease TOMM20 expression in squamous carcinoma cells and decrease MCT4 expression in fibroblasts.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 0
Study Design	Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Condition	Head and Neck Squamous Cell Cancer
Intervention	Drug: Metformin
Study Arm (s)	Experimental: Metformin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	40
Estimated Completion Date	Not Provided
Estimated Primary Completion Date	September 2015
Eligibility Criteria	Inclusion Criteria: - Diagnosis of head and neck cancer biopsy proven, and who have a scheduled appointment for definitive resection of the tumor at TJUH - Age ≥ 18 years of age and ≤80 years old. - Newly diagnosed with HNSCC cancer. - No prior therapy for HNSCC cancer is permitted for enrollment in the trial. - All subjects must be able to comprehend and sign a written informed consent document. Exclusion Criteria: - Pregnant or may become pregnant during metformin administration. - On metformin for any reason during the preceding 4 weeks. - Diabetic patients are eligible if they are not taking metformin, insulin or sulfonylureas. - Received iodinated contrast dye less than 48 hours prior to screening meet a temporary exclusion criteria to receive metformin. These patients cannot start investigational metformin until 48 hours have elapsed from contrast administration. Subjects who are scheduled for iodinated contrast dye administration within 48 hours of definitive surgery are excluded. - Plasma alanine aminotransferase greater than 40 IU/dL. - Plasma aspartate aminotransferase greater than 45 IU/dL. - Plasma creatinine level greater than 1.3 mg/dL. - Plasma alkaline phosphatase greater than 190 IU/dL. - Plasma bicarbonate less than 22 mEq/L or history of lactic or any other metabolic acidosis. - History of congestive heart failure. - Myocardial ischemia or peripheral muscle ischemia. - Sepsis or severe infection. - History of lung disease currently requiring any pharmacologic or supplemental oxygen treatment. - Scheduled for definitive HNSCC cancer surgical resection less than two weeks from enrollment or greater than five weeks from enrollment. - History of hepatic dysfunction or hepatic disease. - Excessive alcohol intake which is defined in accordance with CDC definitions as more than 1 drink per day for women and more than 2 drinks per day for men. All medications are permitted except those that are contraindicated with metformin under current FDA recommendations.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT02083692
Other Study ID Numbers	13D.458
Has Data Monitoring Committee	Yes
Information Provided By	Thomas Jefferson University
Study Sponsor	Thomas Jefferson University
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	March 2014

Locations[ + expand ][ + ]