Pilot Study on Ketogenic Diet and Metformin for Glioblastoma: Feasibility and Metabolic Imaging

Inclusion Criteria

• Must have a confirmed diagnosis of a high-grade brain tumor, such as glioblastoma or similar types.
• Must have had an MRI scan within 21 days before starting the study diet and be on a stable dose of steroids for at least 5 days.
• Must not have been treated with bevacizumab.
• Must not be taking insulin or other diabetes medications and must be at least 6 weeks off these medications.
• Must not have type 1 or type 2 diabetes that requires medication.
• Must be over 18 years old.
• Must have a performance status score of over 60% (able to care for oneself with some assistance).
• Must have a life expectancy of more than 12 weeks.
• Must have normal organ and bone marrow function, as shown by specific blood test results.
• Must not have any serious medical conditions that cannot be controlled or would make it hard to tolerate the treatment.
• If recently had surgery for the tumor, must have recovered from surgery, be on a stable steroid dose, and have had a recent MRI scan.
• Must be able to understand and sign a consent form.

Exclusion Criteria

• Cannot be taking any other experimental treatments.
• Cannot have had previous treatment with bevacizumab or similar drugs.
• Cannot be taking insulin or diabetes medications and must be at least 6 weeks off these medications.
• Cannot have a history of allergic reactions to metformin.
• Cannot have uncontrolled illnesses, such as ongoing infections, heart failure, unstable chest pain, or psychiatric conditions that would affect participation.
• Cannot have another cancer that required treatment in the last year or will need treatment in the next year, except for certain skin or cervical cancers.
• Women and men must agree to use effective birth control during the study due to unknown effects on pregnancy.
• Cannot have current alcoholism.