Pilot Study of Metformin in HNSCC to Investigate the Effects of MF, Tumor Genotype and MF-genotype Interactions, on Tumor Metabolism and Anoikis

February 6, 2017 updated by: West Virginia University

Pilot Study of Metformin (MF) IN HNSCC (Head and Neck Squamous Cell Carcinoma) as Window Trial Design in Operable HNSCC, to Investigate the Effects of MF, Tumor Genotype and MF Genotype Interactions, on Tumor Metabolism and Anoikis

The study researchers want to look at the overall effects that Metformin may have on the tumor characteristics of Head and Neck cancer cells as well as the interactions that Metformin has on the growth or death of tumor cells.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Subjects will sign informed consent and have their medical records reviewed, a physical exam and blood taken for lab tests and a biopsy of the cancer will be taken to determine eligibility for the study.

Following enrollment, the subject will begin to take Metformin at a dosage of 850 mg daily on Days 1 through 3 (in the mornings with breakfast). On day 3 the study team will call to see if the subject is tolerating the Metformin.

If tolerated, then the dose will increase to 850 mg twice a day (with breakfast and dinner) on starting on Day 4.

This dose is to continue until 24 hours prior to surgery, with a minimum of 14 days but can be extended until 28 days dependent on planned surgery date.

The study team will provide the subject with the Metformin and a study diary to record when they take their pills and if there are any issues to communicate to the physician. They will also be contacted by phone or planned visit days to see how their body is tolerating the Metformin throughout their treatment (approximately every 3 days).

On Day 14 plus or minus 3 days (or 2 weeks after staring Metformin) and immediately prior to surgery, the physician will collect a blood sample.

On the day of surgery, the surgeon will remove the tumor and send it to the lab for evaluation as part of standard cancer care. They will also collect an additional biopsy of the tumor for research purposes to test the effects of Metformin on the tumor cells.

The subjects will be followed for 30 days after their surgery.

The blood and tumor samples collected will be sent to a research lab at WVU for to test the effect of Metformin, tumor genotype and Metformin genotype interactions on critical tumor cell metabolic parameters and also on anoikis-sensitivity.

Study Type

Interventional

Enrollment (Actual)

3

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
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Hospitals - Mary Babb Randolph Cancer Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Newly diagnosed HNSCC Stage II-IVB (T1N1-3, T2-3, N0-3, M0) OR Patients with suspected Stage II-IVB tumor as determined by clinical examination or noted via imaging.
  • Planned complete resection of the primary tumor.
  • Age >= 18 years.
  • ECOG performance status of 0 or 1
  • Adequate hepatic, renal, and bone marrow function

Exclusion Criteria:

  • Prior therapy for head and neck cancer
  • Candidates for neo-adjuvant chemotherapy or chemo-radiation therapy for curative intent.
  • Co-existing malignancy or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma or in situ cervical cancer.
  • History of diabetes mellitus or taking any medications indicated for diabetes mellitus treatment
  • Contraindication to metformin including hypersensitivity or allergic reaction
  • Active diagnosis of Alcoholism
  • Congestive heart failure requiring pharmacologic treatment.
  • BMI < 25
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant or breastfeeding women are excluded from this study

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
Metformin 850 mg orally once a day for 3 days, then 850 mg orally twice daily starting day 4 until 24hrs before surgery.
Drug: Metformin
Other Names:
  • Glucophage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor cell death estimated by percentage
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

West Virginia University

Collaborators

West Virginia Clinical and Translational Science Institute

Investigators

  • Principal Investigator: Tanya Fancy, MD, West Virginia 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

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

December 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

March 24, 2015

First Submitted That Met QC Criteria

March 24, 2015

First Posted (Estimate)

March 30, 2015

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WV011614

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Cancer of Head and Neck

Clinical Trials on Metformin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe