Repeated Neural Stem Cell Based Virotherapy with or without N-Acetylcysteine amid (NACA) and Standard Radiation with Temozolomide (TMZ) for the Treatment of Newly Diagnosed High Grade Glioma

Inclusion Criteria

• Have a presumed or confirmed diagnosis of a newly identified high grade glioma (World Heath Organization [WHO] grade 3 or 4) based on clinical and radiologic evaluation. Pathologic confirmation of high grade glioma will be made at the time of biopsy on frozen section by a neuropathologist prior to NSC-CRAd-S-pk7 injection; if this is not possible, the injection will not be performed and the subject will no longer be eligible for the study, and reported as a screen failure
• Partial or gross total tumor resection is feasible based on tumor size, location and extension
• Planning to undergo standard radiation/chemotherapy
• The tumor must be accessible for injection
• Age >= 18 years
• WHO performance status =< 2
• Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) =< 3 x upper limit of normal (within 28 days prior to registration)
• Serum creatinine < 2mg/dl (within 28 days prior to registration)
• Platelets >= 100,000/mm^3 (within 28 days prior to registration)
• White blood cell (WBC) >= 3000/mm^3 (within 28 days prior to registration)
• Able to undergo a brain magnetic resonance imaging (MRI) scan
• Females of child-bearing potential (FOCBP) and males must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)
• FOCBP must have a negative pregnancy test at screening and within 7-10 days prior to receiving study drug
• Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Exclusion Criteria

• Tumor which invades the ventricular system or located in the brain stem
• Have had prior radiation therapy to the brain or prior treatment for their brain tumor (except prior biopsy or subtotal resection)
• Prior or ongoing liver disease including known history of cirrhosis, active hepatitis B or C infection (no formal serologies are required, prior history of resolved hepatitis A infection is not an exclusion criterion)
• Known human immunodeficiency virus (HIV) infection (no formal screening or serology required)
• Evidence of metastatic disease or other malignancy (except squamous or basal cell skin cancers)
• Patients receiving any other investigational agents within 14 days preceding enrollment
• Currently taking immunosuppressive drugs within 14 days of study product injection (with exception of corticosteroids for tumor treatment)
• Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide and/or N-acetylcysteine amide (NACA) are not eligible
• Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible: * Acute grade 3 hypertension requiring control with intravenous medication * Ongoing or active infection requiring systemic treatment * Symptomatic congestive heart failure * Unstable angina pectoris * Unstable cardiac arrhythmia * Psychiatric illness/social situations that would limit compliance with study requirements * Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient’s safety or study endpoints
• Female patients who are pregnant or nursing are not eligible