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TERMINATEDPHASE2

Metformin Hydrochloride and Doxycycline in Treating Patients With Head and Neck Squamous Cell Carcinoma

A Phase II Study of Metformin, Doxycycline, or a Combination of Both Agents in Head and Neck Squamous Cell Carcinoma

NCT03076281•Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Summary

This randomized phase II trial studies how well metformin hydrochloride and doxycycline work in treating patients with head and neck squamous cell carcinoma that can be removed by surgery. Metformin hydrochloride may reduce the metabolic activity of cancer cells and of surrounding supportive tissue. Doxycycline may minimize toxic side effects of anti-cancer therapy. Giving metformin hydrochloride and doxycycline may work better in treating patients with head and neck squamous cell carcinoma.

Detailed Description

PRIMARY OBJECTIVES: I. To determine if treatment with metformin hydrochloride (metformin), doxycycline, or a combination of metformin and doxycycline can increase the percentage of stromal cells that express CAV1 in patients with squamous cell carcinoma of the head and neck. SECONDARY OBJECTIVES: I. To determine the effect of metformin, doxycycline, or metformin and doxycycline treatment on the percentage of tumor cells that are apoptotic as determined by the TdT-Mediated dUTP Nick End Labeling Assay (TUNEL) assay, and express MCT4, MCT1, BGAL, and TOMM20 in squamous carcinoma of head and neck region tumor cells. II. To assess safety and tolerability of metformin, doxycycline, or metformin and doxycycline treatment in subjects with squamous cell carcinoma of the head and neck. TERTIARY OBJECTIVES: I. To assess the effect of metformin, doxycycline, or metformin and doxycycline therapy on the metabolic profile of cancer cells and stroma using mass spectroscopy imaging (MSI) on paired samples, comparing metabolite profiles in the pre-treatment and post-treatment tumor samples. II. To assess the effect of metformin, doxycycline, or metformin and doxycycline therapy on the metabolic state of the patient as characterized serologically by: erythrocyte sedimentation rate, exosome evaluation, metabolomics profile, and micro ribonucleic acid (RNA) expression profiles and physiologically by performing a nutritional assessment via a nutritionist-mediated 3-day dietary recall and comparing a patient's estimated dietary intake against their estimated caloric needs.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosis of head and neck squamous cell carcinoma that is either biopsy proven or suspected based on history, physical, and or radiographic findings, and who are planned for definitive resection of the tumor without the use of neoadjuvant chemotherapy or radiation therapy at TJUH are eligible to participate.
•2. Subjects must be ≥ 18 years of age at time of consent.
•3. Patient must be able to swallow pills.
•4. Patients with serum creatinine levels less than 1.5 mg/dL
•5. Women of childbearing potential must have a negative urine or blood pregnancy test within 14 days of study enrollment.
•6. Informed Consent: All subjects must be able to comprehend and sign a written informed consent document.
•7. ECOG Performance status ≤1

Exclusion Criteria

•1. Subjects that do not have a baseline tumor specimen/biopsy prior to starting study medications.
•a. Tumor specimens do not need to be at Jefferson at time of eligibility determination. Tumor specimens held at outside institutions should be requested for analysis of pre-treatment tumor vs post-treatment tumor.
•2. Subjects who are pregnant or breastfeeding, or may become pregnant during metformin and doxycycline administration.
•3. Received prior cancer therapy for the HNSCC that is being resected.
•4. Subjects on metformin or doxycycline for any reason during the preceding 4 weeks.
•5. Diabetic subjects that are managed by taking metformin or insulin
•6. Subjects who have received iodinated contrast dye must wait 12 hours prior to starting Metformin. If a CT scan with contrast is scheduled after screening and consent, the metformin cannot be taken until after the CT with contrast has been completed and they have waited 12 hours.
•7. Patients with serum creatine ≥1.5 mg/dL
•8. Patients with history of lactic or any other metabolic acidosis.
•9. Patients with history of congestive heart failure stage III or greater.
+9 more criteria

Locations (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

April 3, 2017

Primary Completion Date

December 3, 2018

Completion Date

December 3, 2018

Last Updated

January 29, 2026

Enrollment

ACTUAL participants

Conditions

LarynxLIPOral CavityPharynx

Interventions

Metformin Hydrochloride

DRUG

Doxycycline

DRUG

Metformin +Doxycycline

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Metformin Hydrochloride and Doxycycline in Treating Patients With Head and Neck Squamous Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

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