Status:
COMPLETED
Ketogenic Diet as Adjunctive Treatment in Refractory/End-stage Glioblastoma Multiforme: a Pilot Study
Lead Sponsor:
Mid-Atlantic Epilepsy and Sleep Center, LLC
Collaborating Sponsors:
University of Pittsburgh Medical Center
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The first weekly KD meal package will be given to the patient at the study site. The patient will be instructed in how to process the week-long meal plan package content. Participants will measure uri...
Detailed Description
Malignant gliomas are the most common type of brain tumor in adults. They are the second leading cause of cancer mortality in people under the age of 35 and the fourth leading cause in those under the...
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 recurrence or progression after surgical resection/debulking, radiation and temozolamide chemotherapy.
- Measurable contrast-enhancing progressive or recurrent GBM by MRI imaging ≤ two weeks before screening.
- (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)
- 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 :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01865162
Start Date
January 1 2013
End Date
January 1 2021
Last Update
November 9 2022
Active Locations (1)
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1
MidAtlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States, 20817