GLAD-KE GLioma Biomarker and Safety Assessment During Dietary Ketone Elevation Subtitle: A Surgical Biomarker Discovery Study of Ketogenic Therapy in Recurrent Glioma

Ki vehet részt

• 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
• Age > 18 years
• Willing to submit archival tumor sample if available
• Patients must have the following organ and marrow function:
• Absolute neutrophil count >1,000/mcL
• Total bilirubin < 1.5 x institutional upper limit of normal (ULN) OR total bilirubin >1.5 × ULN with direct bilirubin < 1.5 × ULN
• AST (SGOT) and ALT (SGPT) < 2.5 x institutional ULN
• PT or PTT < 1.5 x institutional ULN
• Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2 calculated by the CKD-EPI equation
• Patients must be maintained on a stable or decreasing dose of systemic corticosteroid regimen of dexamethasone < 4mg (no increase for 5 days) prior to start of study intervention (Day 1). Topical and inhaled steroid treatment is allowed
• Patient must be able to provide written informed consent
• Female participants of childbearing potential must have a negative serum pregnancy test prior to study start
• Patients who have received prior ketogenic therapy (including supplements and diet) may enroll, but must have stopped prior therapy ≥ 7 days prior to day 1
• Patient willing to minimize carbohydrate-containing medications

Ki nem vehet részt

• Other concurrent experimental therapies
• 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
• Known history of clinically significant heart failure (NYHA >2), recent myocardial infarction, or symptomatic atrial fibrillation
• Conditions that may increase the risk of study intervention or significantly reduce compliance (i.e. cognitive impairment, frank dementia, etc.)
• Diabetes mellitus, defined as HbA1c ≥6.5% or use of medications to treat diabetes (note, use of medications for weight loss that have been FDA approved for diabetes is acceptable)
• Contraindication to receiving an MRI (cardiac pacemaker, insulin pumps, non-MRI-compatible stents/clips/plates/rods, non-removable glucose monitor, other non-removable ferromagnetic objects in the body, etc.)
• BMI < 20.0
• Active bowel obstruction, ileus, or active or remote pancreatitis, known gastroparesis/delayed gastric emptying
• Food restrictions that would limit study diet adherence