Patients may participate in this research study if they have glioblastoma. (a brain tumor) that has come back after being treated. Standard treatment for this cancer is a chemotherapy drug called bevacizumab. This research study involves bevacizumab in combination with a special diet called the Modified Atkins Diet (MAD). The purpose of this study is to research if patients can stay on the MAD when it is added to the standard bevacizumab treatment.
Primary Objective \- Determine compliance to treatment at 6 and 12 weeks. Compliance is assessed by review of the daily food diary and the urine and serum ketone levels. Diet compliance is defined as following the diet guidelines 80% of the time with resultant ketosis 80% of the time. If 60% of the patients are compliant with the diet, as defined above, that is a considered a positive result. Secondary Objective(s) * Determine patient compliance in monitoring of blood glucose and urine levels of ketosis. * Determine obstacles to compliance. * Determine the frequency of achieving ketosis, as measured by urine ketones checked daily and serum BHB checked every two weeks. * Determine quality of life (FACT-BR) and adverse events. * Determine response, progression free survival at 6 months (PFS 6), and overall survival (OS). Exploratory Objective * To correlate levels of ketosis and blood sugar with treatment outcome. * To correlate the level of MCT4 expression and IDH1 mutation status with treatment outcome.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Subjects receive Bevacizumab as standard of care
The modified Atkins diet (MAD) includes high fat, unlimited protein, and restricted carbohydrates (\< 20gm/day).
University of Cincinnati
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive cancer Center
Cleveland, Ohio, United States
OhioHealth Research and Innovation Institute
Columbus, Ohio, United States
Number of subjects following Modified Atkins Diet
The number of patients following a Modified Atkins Diet for at least 80% of the time as a measure of feasibility
Time frame: Up to 12 weeks
Number of subjects with ketosis
The number of patients with documented ketosis (Serum beta-hydroxybutyrate (BHB) above 4mg/L) for at least 80% of the time as a measure of feasibility
Time frame: Up to 12 weeks
Correlation of blood sugar levels by compliance level
Correlate the relationship between blood sugar levels and measured level of compliance
Time frame: Up to 12 weeks
Correlation of ketosis values by compliance level
Correlate the relationship between ketosis values and measured level of compliance
Time frame: Up to 12 weeks
Correlation of ketosis values by tumor response
Correlate the relationship between ketosis values and measured level of tumor response as a measure of treatment outcomes
Time frame: Up to 12 weeks
Correlation of blood sugar levels by tumor response
Correlate the relationship between blood sugar levels and measured level of tumor response as a measure of treatment outcomes
Time frame: Up to 12 weeks
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