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

February 20, 2024 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin
Drug: Metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
date of biopsy and date of surgery (9-28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Investigators

  • Principal Investigator: Joseph Curry, MD, Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2013

Primary Completion (Actual)

May 9, 2016

Study Completion (Actual)

April 6, 2017

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (Estimated)

March 11, 2014

Study Record Updates

Last Update Posted (Actual)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13D.458

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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