Pilot Study of Metformin in HNSCC to Investigate the Effects of MF, Tumor Genotype and MF-genotype Interactions, on Tumor Metabolism and Anoikis
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | December 2014 |
| End Date: | June 2016 |
| Contact: | Toni Bulian, RN |
| Email: | ambulian@hsc.wvu.edu |
| Phone: | 304-293-2633 |
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
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.
tumor characteristics of Head and Neck cancer cells as well as the interactions that
Metformin has on the growth or death of tumor cells.
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.
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.
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
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