Back to resultsPilot Study of Metformin in Head and Neck Squamous Cell Cancer and Its Effects on Stromal-epithelial Metabolic Uncoupling
Primary Purpose
Head and Neck Squamous Cell Cancer
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Metformin
Sponsored by
About this trial
This is an interventional basic science trial for Head and Neck Squamous Cell Cancer
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.
Sites / Locations
- Thomas Jefferson University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Metformin
Arm Description
Outcomes
Primary Outcome Measures
Change in TOMM20 and MCT4 expression from tumor cells from date of biopsy and date of surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT02083692
First Posted
March 4, 2014
Last Updated
October 18, 2016
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT02083692
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Metformin
Primary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Curry, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
36328378
Citation
Crist M, Yaniv B, Palackdharry S, Lehn MA, Medvedovic M, Stone T, Gulati S, Karivedu V, Borchers M, Fuhrman B, Crago A, Curry J, Martinez-Outschoorn U, Takiar V, Wise-Draper TM. Metformin increases natural killer cell functions in head and neck squamous cell carcinoma through CXCL1 inhibition. J Immunother Cancer. 2022 Nov;10(11):e005632. doi: 10.1136/jitc-2022-005632.
Results Reference
derived
PubMed Identifier
31593308
Citation
Amin D, Richa T, Mollaee M, Zhan T, Tassone P, Johnson J, Luginbuhl A, Cognetti D, Martinez-Outschoorn U, Stapp R, Solomides C, Rodeck U, Curry J. Metformin Effects on FOXP3+ and CD8+ T Cell Infiltrates of Head and Neck Squamous Cell Carcinoma. Laryngoscope. 2020 Sep;130(9):E490-E498. doi: 10.1002/lary.28336. Epub 2019 Oct 8.
Results Reference
derived
PubMed Identifier
28185288
Citation
Curry J, Johnson J, Tassone P, Vidal MD, Menezes DW, Sprandio J, Mollaee M, Cotzia P, Birbe R, Lin Z, Gill K, Duddy E, Zhan T, Leiby B, Reyzer M, Cognetti D, Luginbuhl A, Tuluc M, Martinez-Outschoorn U. Metformin effects on head and neck squamous carcinoma microenvironment: Window of opportunity trial. Laryngoscope. 2017 Aug;127(8):1808-1815. doi: 10.1002/lary.26489. Epub 2017 Feb 10.
Results Reference
derived
Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital
Learn more about this trial
Pilot Study of Metformin in Head and Neck Squamous Cell Cancer and Its Effects on Stromal-epithelial Metabolic Uncoupling
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