Head and Neck Squamous Cell CancerEarly Phase 1NCT02083692
Pilot Study of Metformin in Head and Neck Squamous Cell Cancer and Its Effects on Stromal-epithelial Metabolic Uncoupling
A Early Phase 1 study testing Metformin in people with Head and Neck Squamous Cell Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Squamous Cell Cancer
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2013to 6 Apr 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: 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.
- Conditions
- Head and Neck Squamous Cell Cancer
- Being tested
- Metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Not described Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TOMM20 and MCT4 expression from tumor cells from date of biopsy and date of surgery
Measured: date of biopsy and date of surgery (9-28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study start5 Sep 2013
- Primary completion9 May 2016
- Study completion6 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Curry, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083692
- Sponsor's protocol ID
- 13D.458
- Other IDs
- JT 3153
- Status last verified
- May 2025
- First submitted
- 4 Mar 2014
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36328378Amin 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.
PubMed 31593308Curry 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.
PubMed 28185288
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Metformin in Head and Neck Squamous Cell Cancer and Its Effects on Stromal-epithelial Metabolic Uncoupling.
- ClinicalTrials.gov ID
- NCT02083692
- Acronym / sponsor ID
- 13D.458
- Conditions
- Head and Neck Squamous Cell Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 5 Sep 2013 (actual)
- Primary completion
- 9 May 2016 (actual)
- Study completion
- 6 Apr 2017 (actual)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: Metformin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin | Drug | Metformin |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Derived from this study: PubMed 36328378Crist 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.
- Derived from this study: PubMed 31593308Amin 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.
- Derived from this study: PubMed 28185288Curry 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.
- Thomas Jefferson University HospitalLink provided by the sponsor.
Related trials for Head and Neck Squamous Cell Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruiting
Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma
Squamous Cell Cancer of Head and Neck (SCCHN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Curry, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Metformin in people with Head and Neck Squamous Cell Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02083692, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.