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

Inclusion Criteria:

* Ability to understand and willingness to sign informed consent (power of attorney and/or legally authorized representatives cannot sign on behalf of the patient)
* Patients must have newly diagnosed (i.e., within 5 weeks), histologically or cytologically confirmed glioblastoma multiforme.
* Diagnosis must be made by surgical biopsy or excision.
* Therapy must begin ≤ 5 weeks after surgery or biopsy
* Age ≥ 18 years
* ECOG performance status 0-2. (KPS \> 50)
* Absolute neutrophil count (ANC) ≥ 1500 cells per mm3
* Platelets ≥ 100,000 per mm3
* Hemoglobin ≥ 8 g/dL
* Creatinine ≤ 2.0 mg
* Total bilirubin ≤ 1.5 mg/dL
* ALT ≤ 3 times the institutional upper limit of normal
* AST ≤ 3 times the institutional upper limit of normal
* Tolerate one test dose (15g) of ascorbate.
* Not pregnant.

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.