Status:
COMPLETED
Ketogenic Diet Treatment Adjunctive to Radiation and Chemotherapy in Glioblastoma Multiforme: a Pilot Study
Lead Sponsor:
Mid-Atlantic Epilepsy and Sleep Center, LLC
Collaborating Sponsors:
Neuroscience Research Foundation, Sewickley,PA
Conditions:
Glioblastoma Multiforme of Brain
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The goal of the present study is to evaluate efficacy, safety and tolerability of 4:1 ketogenic diet administered adjunctively to standard radiation and temozolomide chemotherapy in patients with GBM ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Age 18-65
- Ability and willingness to signed informed consent form
- Astrocytoma grade 4 (glioblastoma multiforme, GBM, histologically confirmed, WHO criteria)
- Documented surgical resection/debulking
- Measurable contrast-enhancing GBM by MRI imaging ≤ two weeks before screening or prior to surgery if done ≤ 2 months before
- Karnovsky Performance Score of 70 or more
Exclusion
- 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)
- Prior treatment with any of the following: (a) small-molecule kinase inhibitor; (b) non-cytotoxic hormonal agent; (c) KD ≤6 months of enrollment
- Planned continued use of glucocorticoids
- 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)
- 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
- 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
- History of uncontrolled hyperlipidemia
- Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators would interfere with adherence to study requirements
- History of human immunodeficiency virus, or hepatitis C
- Failure to recover from \<CTCAE grade 2 toxicities related to prior therapy
- Pregnancy or breastfeeding
- Use of any investigational drug within 1 months of enrollment
- Inability or unwillingness of subject to give written informed consent
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT02302235
Start Date
February 1 2014
End Date
May 1 2022
Last Update
August 11 2022
Active Locations (1)
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1
MidAtlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States, 20817