A Pilot Study of Ketogenic Diet and Metformin in Glioblastoma: Feasibility and Metabolic Imaging

Inclusion Criteria

• •1. Patients must have histologically confirmed high-grade glioma (e.g. glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma or other anaplastic gliomas).
• •2. Patients must have an MRI performed within 21 days prior to beginning the study diet and on a fixed dose of steroids for at least 5 days. If the steroid dose is increased between the date of imaging and registration, a new baseline MR/CT is required.
• •3. Patients must not have been exposed to bevacizumab.
• •4. Patients cannot be taking insulin or other oral hypoglycemic. Must be at least 6 weeks from last oral hypoglycemic or insulin.
• •5. Must not have known type 1 or type 2 diabetes and expected to need either insulin and/or an oral hypoglycemic agents within the next 6 months.
• •6. Patients must be \>18 years old.
• •7. Karnofsky performance status \>60%.
• •8. Life expectancy of greater than 12 weeks.
• •9. Patients must have normal organ and marrow function as defined below:
• •* Leukocytes \>3,000/mcL
• •* Absolute neutrophil count \>1,000/mcL
• •* Platelets \>100,000/mcL
• •* Total bilirubin \<2.0 X institutional upper limit of normal (unless known to have Gilbert's Disease)
• •* AST (SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal
• •* Serum Glucose: \< 200 mg/dL
• •* Creatinine \< 1.5 mg/dL (for males), \< 1.4 mg/dL (for females), or within normal lab limits OR
• •* Creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
• •10. Patients must not have any significant medical illnesses that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patients' ability to tolerate this therapy
• •11. Patients having undergone recent resection or progressive tumor will be eligible as long as all of the following conditions apply:
• •1. They have recovered from the effects of surgery.
• •2. On a steroid dosage that has been stable for at least 5 days.
• •3. Residual disease following resection of recurrent tumor is not mandated for eligibility into the study. To best assess the extent of residual disease postoperatively, a MRI should be done:
• •* No later than 96 hours in the immediate post-operative period or
• •* At least 4 weeks post-operatively, and
• •* Within 14 days of registration, and
• •* If the 96-hour scan is more than 21 days before registration, the scan needs to be repeated. If the steroid dose is increased between the date of imaging and registration, a new baseline MRI is required on a stable steroid dosage for at least 5 days.
• •12. Patients must have the ability to understand and the willingness to sign a written informed consent document.