Clinical Trial Details
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NCT01865162 : Ketogenic Diet as Adjunctive Treatment in Refractory/End-stage Glioblastoma Multiforme: a Pilot Study
PhasePhase 1
AgesMin: 18 Years Max: 65 Years
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

4. Documented recurrence or progression after surgical resection/debulking, radiation and
temozolamide chemotherapy.

5. Measurable contrast-enhancing progressive or recurrent GBM by MRI imaging = two weeks
before screening.

6. (a) = 3months after completion of radiation; (b) 6 weeks from a nitrosourea
chemotherapy; (c) = weeks from a non-nitrosourea chemotherapy (all [a-c] in order to
allow recovery from the potential of severe toxicity related to these treatments)

7. 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

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

6. History of non-glioma malignancy other than:

- Surgically excised non-melanoma skin cancer or in situ carcinoma of the cervix.

- 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
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