Pilot Study of Metformin in HNSCC to Investigate the Effects of MF, Tumor Genotype and MF-genotype Interactions, on Tumor Metabolism and Anoikis

• Status: Terminated
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The study researchers want to look at the overall effects that Metformin may have on the tumor characteristics of Head and Neck cancer cells as well as the interactions that Metformin has on the growth or death of tumor cells.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: West Virginia University
• Collaborators: West Virginia Clinical & Translational Science Institute; West Virginia Clinical and Translational Science Institute
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Newly diagnosed HNSCC Stage II-IVB (T1N1-3, T2-3, N0-3, M0) OR Patients with suspected Stage II-IVB tumor as determined by clinical examination or noted via imaging.

• Planned complete resection of the primary tumor.

• Age >= 18 years.

• ECOG performance status of 0 or 1

• Adequate hepatic, renal, and bone marrow function

Exclusion Criteria:

• Prior therapy for head and neck cancer

• Candidates for neo-adjuvant chemotherapy or chemo-radiation therapy for curative intent.

• Co-existing malignancy or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma or in situ cervical cancer.

• History of diabetes mellitus or taking any medications indicated for diabetes mellitus treatment

• Contraindication to metformin including hypersensitivity or allergic reaction

• Active diagnosis of Alcoholism

• Congestive heart failure requiring pharmacologic treatment.

• BMI < 25

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

• Pregnant or breastfeeding women are excluded from this study