A Phase 2 Trial of High-Dose Ascorbate in Glioblastoma Multiforme

Exclusion Criteria

• •Recurrent high grade glioma
• •G6PD (glucose-6-phosphate dehydrogenase) deficiency.
• •Patients actively receiving insulin or using a finger-stick glucometer daily for blood glucose measurements
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide.
• •Significant co-morbid central nervous system disease, including but not limited to, multiple sclerosis.
• •Patients who are on the following drugs and cannot have a drug substitution: warfarin, flecainide, methadone, amphetamines, quinidine, and chlorpropamide.
• •Known active concurrent malignancy, as determined by treating physicians.
• •Patients who have received prior chemotherapy (including Gliadel wafers) for the current glioma.
• •Prior radiation therapy to the head or neck resulting in overlap of RT fields.
• •Patients receiving any other investigational agents (imaging agents are acceptable)
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection that would result in a hospital stay or delay of treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or impact patient safety.
• •Pregnant women.
• •Breastfeeding women.
• •Known HIV-positive individuals. High-dose ascorbate acid is a known CYP450 3A4 inducer, which results in lower serum levels of antiretroviral drugs.