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Antibiotic
Arm A (metformin hydrochloride) for Laryngitis
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
Study 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
- Laryngitis
- Lipodystrophy
- 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreTrial 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
Find a Location
Who is running the clinical trial?
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
10,904 Total Patients Enrolled
Jennifer Johnson, MD, PhDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University
5 Previous Clinical Trials
100,126 Total Patients Enrolled
Frequently Asked Questions
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