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Antibiotic

Metformin Hydrochloride and Doxycycline in Treating Patients With Head and Neck Squamous Cell Carcinoma That Can Be Removed by Surgery

Phase 2

Waitlist Available

Led By Jennifer Johnson, MD, PhD

Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 30 days after last drug dose

Awards & highlights

All Individual Drugs Already Approved

Approved for 60 Other Conditions

No Placebo-Only Group

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.

Eligible Conditions

Lip
Laryngitis
Mouth
Pharynx

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 30 days after last drug dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 30 days after last drug dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 30 days after last drug dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in percent of CFS expressing CAV-1 at an intensity of 1+ or greater assessed in tumor-associated stroma cells by immunohistochemistry (IHC)

Secondary study objectives

Change in percent of tumor cells expressing MCT4, that are TUNEL positive and that express BGAL

Change in percent of tumor cells expressing MCT4, that are TUNEL positive and that express MCT1

Change in percent of tumor cells expressing MCT4, that are TUNEL positive and that express MCT4

+2 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm C (metformin hydrochloride, doxycycline)Experimental Treatment1 Intervention

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.

Group II: Arm B (doxycycline)Experimental Treatment1 Intervention

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.

Group III: Arm A (metformin hydrochloride)Experimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metformin

FDA approved

Doxycycline

FDA approved

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