Ketogenic Diet Treatment Adjunctive to Radiation and Chemotherapy in Glioblastoma Multiforme: a Pilot Study

Exclusion Criteria

• •1. Acute intracranial or intratumoral hemorrhage \> Grade 1 either by MRI or CT scan ≤2 weeks of screening. (Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin may enter the study)
• •2. Prior treatment with any of the following: (a) small-molecule kinase inhibitor; (b) non-cytotoxic hormonal agent; (c) KD ≤6 months of enrollment
• •3. Planned continued use of glucocorticoids
• •4. Anticoagulation treatment with ≥ 1 mg/day coumadin ≤ 7 days prior to screening (low-dose \[≤ 1 mg/day\] coumadin, heparin, and low-molecular-weight heparin are permitted)
• •5. Any systemic illness or unstable medical condition that might pose additional risk, including: cardiac, unstable metabolic or endocrine disturbances, renal or liver disease, past history of renal calculi, hyperuricemia, hypercalcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, carnitine deficiency and pancreatitis
• •6. History of non-glioma malignancy other than:
• •1. Surgically excised non-melanoma skin cancer or in situ carcinoma of the cervix
• •2. A malignancy diagnosed ≥2 years ago if the subject has had no evidence of disease for 2 years prior to screening
• •7. History of uncontrolled hyperlipidemia
• •8. Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators would interfere with adherence to study requirements
• •9. History of human immunodeficiency virus, or hepatitis C
• •10. Failure to recover from \<CTCAE grade 2 toxicities related to prior therapy
• •11. Pregnancy or breastfeeding
• •12. Use of any investigational drug within 1 months of enrollment
• •13. Inability or unwillingness of subject to give written informed consent