NCT02768389

Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma

A Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Glioblastoma
• Brain Tumor

Interventions

Type	Name	Description
DRUG	Bevacizumab	Subjects receive Bevacizumab as standard of care
BEHAVIORAL	Modified Atkins Diet	The modified Atkins diet (MAD) includes high fat, unlimited protein, and restricted carbohydrates (\< 20gm/day).

Timeline

• Start date: 2016-09-06
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2016-05-11
• Last updated: 2019-03-15

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study