Spots Global Cancer Trial Database for Pilot Study of Metformin in HNSCC to Investigate the Effects of MF, Tumor Genotype and MF-genotype Interactions, on Tumor Metabolism and Anoikis

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Trial Identification

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

Official Title: Pilot Study of Metformin (MF) IN HNSCC (Head and Neck Squamous Cell Carcinoma) as Window Trial Design in Operable HNSCC, to Investigate the Effects of MF, Tumor Genotype and MF Genotype Interactions, on Tumor Metabolism and Anoikis

Study ID: NCT02402348

Conditions

Cancer of Head and Neck

Interventions

Metformin

Study Description

Brief 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.

Detailed Description: Subjects will sign informed consent and have their medical records reviewed, a physical exam and blood taken for lab tests and a biopsy of the cancer will be taken to determine eligibility for the study. Following enrollment, the subject will begin to take Metformin at a dosage of 850 mg daily on Days 1 through 3 (in the mornings with breakfast). On day 3 the study team will call to see if the subject is tolerating the Metformin. If tolerated, then the dose will increase to 850 mg twice a day (with breakfast and dinner) on starting on Day 4. This dose is to continue until 24 hours prior to surgery, with a minimum of 14 days but can be extended until 28 days dependent on planned surgery date. The study team will provide the subject with the Metformin and a study diary to record when they take their pills and if there are any issues to communicate to the physician. They will also be contacted by phone or planned visit days to see how their body is tolerating the Metformin throughout their treatment (approximately every 3 days). On Day 14 plus or minus 3 days (or 2 weeks after staring Metformin) and immediately prior to surgery, the physician will collect a blood sample. On the day of surgery, the surgeon will remove the tumor and send it to the lab for evaluation as part of standard cancer care. They will also collect an additional biopsy of the tumor for research purposes to test the effects of Metformin on the tumor cells. The subjects will be followed for 30 days after their surgery. The blood and tumor samples collected will be sent to a research lab at WVU for to test the effect of Metformin, tumor genotype and Metformin genotype interactions on critical tumor cell metabolic parameters and also on anoikis-sensitivity.