Metformin Hydrochloride and Doxycycline in Treating Patients With Head and Neck Squamous Cell Carcinoma That Can Be Removed by Surgery
NCT ID: NCT03076281
Last Updated: 2018-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
7 participants
INTERVENTIONAL
2017-04-03
2020-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Arm A (metformin hydrochloride)
Patients receive metformin hydrochloride PO daily on days 1-3 and twice daily starting on day 4 to the day prior to surgery in the absence of disease progression or unacceptable toxicity
Metformin Hydrochloride
Given orally
Arm B (doxycycline)
Patients receive doxycycline PO every 12 hours on days 1 to the day prior to surgery in the absence of disease progression or unacceptable toxicity.
Doxycycline
Given orally
Arm C (metformin hydrochloride, doxycycline)
Patients receive metformin hydrochloride PO daily on days 1-3 and twice daily starting on day 4 to the day prior to surgery and doxycycline PO every 12 hours on days 1to the day prior to surgery in the absence of disease progression or unacceptable toxicity.
Metformin +Doxycycline
Given orally
Interventions
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Metformin Hydrochloride
Given orally
Doxycycline
Given orally
Metformin +Doxycycline
Given orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
10. Patients scheduled for definitive cancer surgical resection less than 7 days from beginning of study drug administration or greater than 6 weeks from beginning study drug administration.
11. Patients with history of hepatic dysfunction or hepatic disease and abnormal liver function tests defined as AST, ALT, Alk Phos, and or total bilirubin greater than 2.5 times the upper limit of normal. Patients who have a history of hepatic dysfunction or hepatic disease and normal liver function tests will be eligible to participate.
12. Patients with a current history (in the past 30 days) of heavy drinking which is defined in accordance with CDC definition as more than 8 drinks per week for women and more than 15 drinks per week for men. A standard drink contains .6 ounces of pure alcohol. Generally, this amount of pure alcohol is found in 12-ounces of beer, 8-ounces of malt liquor, 5-ounces of wine, 1.5-ounces or a "shot" of 80-proof distilled spirits or liquor (e.g., gin, rum, vodka, or whiskey). While on study, patients should limit their alcohol consumption to no more than 8 drinks per week for women and no more than 15 drinks per week for men.
13. Patient with prior allergic reaction to metformin, doxycycline, or any other tetracycline antibiotic in the past.
14. Patient is on medications that are contraindicated with metformin or doxycycline under current FDA recommendations. The following is a list of medications identified as class D (consider therapy modification) when treatment with metformin or doxycycline is considered:
* Class D:
* Bismuth Subsalicylate
* Cimetidine
* Iodinated cont
18 Years
ALL
No
Sponsors
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Sidney Kimmel Cancer Center at Thomas Jefferson University
OTHER
Responsible Party
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Principal Investigators
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Jennifer Johnson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Sidney Kimmel Cancer Center at Thomas Jefferson University
Locations
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Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Countries
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Related Links
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Sidney Kimmel Cancer Center
Thomas Jefferson University Hospital
Other Identifiers
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16D.703
Identifier Type: -
Identifier Source: org_study_id