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

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ClinicalTrials.gov Identifier: NCT02083692
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

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.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Cancer Drug: Metformin Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pilot Study of Metformin in Head and Neck Squamous Cell Cancer and Its Effects on Stromal-epithelial Metabolic Uncoupling.
Study Start Date : September 2013
Actual Primary Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Metformin Drug: Metformin



Primary Outcome Measures :
  1. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083692


Locations
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United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
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Principal Investigator: Joseph Curry, MD Thomas Jefferson University
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02083692    
Other Study ID Numbers: 13D.458
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs