Partial Brain RT, Temozolomide, Chloroquine, and TTF Therapy for the Treatment of Newly Diagnosed Glioblastoma

Inclusion Criteria:

• Histologically confirmed newly diagnosed grade IV glioma (gliosarcoma allowed)

• The subject must have recovered from the effects of surgery, postoperativeinfection, and other complications before enrollment. Post-operative unenhanced andcontrast-enhanced MRI scan should be done within 72 hours after surgery. If it isnot obtained within 72 hours post-resection, then an MRI obtained at least 2 weeks (or longer) after surgery is required

• Karnofsky performance status >= 70%

• Absolute neutrophil count >= 1,500/mm^3 (=< 21 days prior to registration)

• Platelets >= 100,000/mm^3 (=< 21 days prior to registration)

• Hemoglobin (Hgb) >= 9.0 g/dL (Note: The use of transfusion or other intervention toachieve Hgb >= 9.0 g/dL is acceptable.) (=< 21 days prior to registration)

• Calculated creatinine clearance >= 30 mL/min by Cockcroft-Gault formula (=< 21 daysprior to registration)

• Total bilirubin =< 1.5 times upper limit of normal (ULN) (=< 21 days prior toregistration)

• Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 1.5 times upper limit of normal (ULN) (=< 21 days prior to registration)

• Female subjects of childbearing potential (i.e., those who are not postmenopausalfor at least 1 year or surgically sterile by bilateral tubal ligation, bilateraloophorectomy or hysterectomy) and their male partners should practice at least oneof the methods of birth control listed below during study entry, for the entireduration of the study and for at least 6 months after treatment with temozolomideand chloroquine:

• A vasectomized male subject or a vasectomized partner of a female subject;hormonal contraceptives (oral, parenteral, or transdermal) for at least 3 monthsprior to study drug administration; intrauterine device (females); double-barriermethod (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidaljellies or cream)

• Female subjects of child-bearing potential must have a negative pregnancy test (urine or serum) within 3 days of registration

• Must voluntarily sign and date informed consent form for study participation,approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB),prior to the initiation of any screening or study-specific procedures

Exclusion Criteria:

• Gliomatosis cerebri (a diffuse glioma [usually astrocytic] growth pattern consistingof exceptionally extensive infiltration of a large region of the central nervoussystem, with involvement of at least 3 cerebral lobes, usually with bilateralinvolvement of the cerebral hemispheres and/or deep grey matter, and frequentextension to the brain stem, cerebellum, and even the spinal cord.)

• Recurrent glioblastoma (GBM)

• Metastatic GBM

• Infratentorial tumor

• Prior chemotherapy or radiosensitizers for cancers of the head and neck region; notethat prior chemotherapy for a different cancer is allowable, except priortemozolomide. Implanted carmustine (BCNU) wafer is allowed

• Prior radiotherapy to the head or neck (except for T1 glottic cancer ornonmelanomatous skin cancer), resulting in overlap of radiation fields

• Any prior therapy for glioblastoma besides surgery (intra-operative techniques toguide resection and experimental imaging techniques are allowed). BCNU wafer isallowed

• Prior invasive malignancy (except for non-melanomatous skin cancer; carcinoma insitu (CIS) of the breast, CIS oral cavity, or CIS cervix, T1 glottic cancer) unlessdisease free for >= 5 years

• Prior, concomitant, or planned concomitant treatment with bevacizumab, carmustineimplant (Gliadel) wafers or other intratumoral or intracavitary anti-neoplastictherapy, or other experimental therapeutics intended to treat the tumor; theexceptions are diagnostic and operative guides to improve extent of resection orimaging studies, quality of life, biomarker, or epidemiological studies

• History of hypersensitivity to temozolomide or excipients

• Known glucose-6-phosphate dehydrogenase (G6PD) deficiency

• Lactating or pregnant female

• Severe, active, co-morbidity defined as follows:

• Moderate or severe hepatic impairment (Child-Pugh category B or higher [score of 7or higher ]); unstable angina and/or congestive heart failure within the last 6months; transmural myocardial infarction within the last 6 months; evidence ofrecent myocardial infarction or ischemia by the findings of S-T elevations of >= 2mm using the analysis of an electrocardiogram (EKG) performed within 14 days priorto enrollment; New York Heart Association grade II or greater congestive heartfailure requiring hospitalization within 12 months prior to enrollment

• History of stroke, cerebral vascular accident (CVA), or transient ischemic attackwithin 6 months (except if intra- or post-operative); serious and inadequatelycontrolled cardiac arrhythmia; acute bacterial or fungal infection requiringintravenous antibiotics at the time of enrollment; chronic obstructive pulmonarydisease exacerbation or other respiratory illness requiring hospitalization orprecluding study therapy at the time of enrollment; uncontrolled humanimmunodeficiency virus (HIV) with CD4 count < 200; note, however, that HIV testingis not required for entry into this protocol

• Any other major medical illnesses or psychiatric impairments that in theinvestigator's opinion will prevent administration or completion of protocol therapy

• Subjects treated on any other therapeutic clinical protocols within 30 days prior tostudy entry or during participation in the study, except intra-operative therapy toguide resection or experimental imaging without therapeutic intent

• Inability to undergo contrast-enhanced MRI scans

• Presence of implanted pacemaker, programmable shunts, defibrillator, deep brainstimulator, or other implanted electronic devices in the brain

• Documented clinically significant arrhythmia or severe ischemic heart disease

• Patients with underlying ocular disorders, including but not limited to:maculopathy, macular degeneration, and retinopathy