This study is being done to see if a Ketogenic Diet (KD) or short-term Ketone supplement (KS) is feasible and safe for patients with recurrent Glioma who are undergoing a clinically indicated surgery.
Histopathologic diagnosis of a glioma that has received prior irradiation and is presumed recurrent.
Clinical indication for open biopsy or surgical resection.
On MRI, a 2x2x2 cm enhancement absent of bleed, calcification, or other features that can obscure MRS signal.
Karnofsky performance status ≥ 70.
Patients with a history of a metabolic disorder including documented defect in urea metabolism (including documented history of gout), carnitine deficiency (primary carnitine deficiency, carnitine palmitoyl transferase I or II deficiency, carnitine translocase deficiency), fatty acid metabolism, beta-oxidation defects, pyruvate carboxylase deficiency, mitochondrial function, porphyria, or treatment refractory nephrolithiasis.
Active uncontrolled infection.
BMI < 20.0.
Active bowel obstruction, ileus, or active or remote pancreatitis, known gastroparesis/delayed gastric emptying.
Single group
Arm 1 will use Ketone supplement 80 gm daily
Dietary supplementArm 1 will use Ketone supplement 80 gm daily
Arm 2 will follow Ketogenic Diet 7 days leading up to the clinically indicated surgery.
Other interventionArm 2 participants will follow a 2.5:1 - 3:1 ketogenic diet (KD) daily for 7 days leading up to the clinically indicated surgery.
Feasibility as assessed by Proportion of patients who complete 80% or more of the study intervention
Proportion of patients who complete 80% or more of the study intervention
Safety as assessed by incidence and severity of treatment-associated adverse events
Safety as measured by incidence and severity of treatment-associated adverse events attributed to study intervention as graded by the CTCAE v6.0
Proportion of patients achieving beta-hydroxybuterate (Analysis of metabolic marker BHB)
Proportion of patients achieving beta-hydroxybuterate (BHB) on MRS (BHB/tCr ratio) greater than 1.0 at Day 7 of intervention.
Change in beta-hydroxybuterate (BHB) on Magnetic Resonance Imaging with intervention
Change in beta-hydroxybuterate (BHB) on Magnetic Resonance Imaging (MRI)
Change in beta-hydroxybuterate (BHB) on Spectroscopy (MRS)
Change in beta-hydroxybuterate (BHB) on Spectroscopy (MRS) with intervention (BHB/tCr ratio D7 vs pre-treatment)
Detection of Acetone (mL)
Detection of Acetone on MRS with intervention
Click on the lead sponsor to view all of their trials.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
Ludwig Institute for Cancer Research
Collaborator
Kenetik
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
