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

Primary aims of the study will be to 1) To evaluate efficacy of ketogenic diet as adjunctive
treatment of radiation treatment in glioblastoma multiforme. 2) To evaluate the safety of
ketogenic diet as adjunctive treatment of radiation treatment in glioblastoma multiforme.
Secondary aim will be to evaluate tolerability of ketogenic diet as adjunctive treatment of
radiation treatment in glioblastoma multiforme.

Participants will be seen at one, 2 weeks, and 4 weeks after KG diet initiation, and then
monthly until month 6 after diet initiation, then every 2 months until 2 years after
treatment initiation or death, then every 3 months until 3 years after treatment initiation
or death. KD treatment will last for 6 months or until exit criteria are met, whichever comes
first. Exit criteria are the primary outcome measures, the first of either (a) MRI tumor
progression or (b) death. Secondary outcome measures will include treatment compliance,
hunger scale scores, fasting serum glucose and BOH levels and occurrence of adverse events.

Patients with documented tumor progression will receive standard care for progressive GBM as
directed by their treating oncologist, independent of the study.

Inclusion Criteria:

1. Age 18-65

2. Ability and willingness to signed informed consent form

3. Astrocytoma grade 4 (glioblastoma multiforme, GBM, histologically confirmed, WHO
criteria)

4. Documented surgical resection/debulking

5. Measurable contrast-enhancing GBM by MRI imaging ≤ two weeks before screening or prior
to surgery if done ≤ 2 months before

6. Karnovsky Performance Score of 70 or more

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
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