Efficacy Study of Oral Arginine to Improve Immune Function in Glioblastoma Multiforme

Inclusion criteria

• Age 18 and above.
• Imaging consistent with GBM without clinical indication for primary CNS lymphoma or abscess, as determined by the treating physician.
• Patient must be planned to proceed to definitive surgery intended for tumor resection, rather than needle biopsy, within a reasonable time frame from initial evaluation (7-14 days).
• Patient must be neurologically stable, allowing for reasonable time frame between initial evaluation and subsequent surgical procedure (7-14 days).
• Patient must have initial KPS greater than 80.
• At the time of initial evaluation the patient must be on a stable dose of steroid medication if indicated.
• Patient must have laboratory values, as determined by institutional controls, within the following parameters:

• White blood cell count above lowest level for normal range
• Renal function within normal limits (creatinine, BUN)
• Liver function within normal limits (AST/ALT, total bilirubin, alkaline phosphatase)
• Written informed consent is obtained prior to initiation of study procedures.

Exclusion criteria

• Known autoimmune condition, underlying immune disease, or use of immunomodulatory prescription drugs (aside from steroids) for any medical condition.
• Prescribed vasodilator medications: Phosphodiesterase Inhibitors: Sildenafil (Viagra), Nitrates, Alpha blockers: Terazosin (Hytrin), doxazosin (Cardura), alfuzosin (Uroxatral), tamsulosin (Flomax), and prazosin (Minipress).
• Glaucoma
• Known Herpes simplex virus (i.e. cold sores)
• History of myocardial infarction or coronary artery disease.
• Known allergy or intolerance to arginine.
• Uncontrolled or poorly controlled seizures.
• KPS less than 80.
• Known renal or hepatic insufficiency or failure.
• Known deficiency or dysfunction of intestinal absorption or motility.
• History of other malignancy regardless of current status or treatment.
• Underlying psychiatric condition or altered mental status that would violate stringent acquisition of informed consent or potentially preclude, in the opinion of the investigator, compliance with study requirements
• Pregnancy