Personalized Mutation-Derived Tumor Vaccine, Poly ICLC, and NovoTTF-200A in Treating Patients with Glioblastoma

Inclusion Criteria

• The subject must be age >= 18
• The subject must have histological confirmation of GBM (World Health Organization [WHO] grade IV)
• The subject must have stable disease after treatment of radiation with concurrent chemotherapy; if the disease is not stable or progresses while in the study the patient is allowed to continue on the study receiving the vaccine if the tumor gets controlled by other modality treatment(s)
• The subject must have received maximal debulking surgery and undergo radiotherapy concomitant with temozolomide (45-70 gray [Gy])
• The subject must have a life expectancy > 16 weeks
• The subject must have a performance status of 0-2 as determined by criteria set forward by the Eastern Cooperative Oncology Group and/or Karnofsky performance status (KPS) 70-100
• The subject must have first vaccine treatment start date at least 4 weeks out from the last dose of concomitant temozolomide or radiotherapy
• The subject must have archival tumor tissue that is sufficient quantity and quality for sequencing
• The subject requires dexamethasone =< 4 mg daily on a stable dose
• White blood count (WBC) > 3,000/ul (performed within 14 days prior to study)
• Hemoglobin > 10 gm/dl (performed within 14 days prior to study)
• Absolute neutrophil count >= 1500/mm^3 (performed within 14 days prior to study)
• Platelet count >= 100,000/mm^3 (performed within 14 days prior to study)
• Creatinine =< 2.5 mg/dL (performed within 14 days prior to study)
• Alanine aminotransferase (ALT) < 3 times the upper limits of the institutional normal (performed within 14 days prior to study)
• Aspartate aminotransferase (AST) < 3 times the upper limits of the institutional normal (performed within 14 days prior to study)
• Alkaline phosphatase < 3 times the upper limits of the institutional normal (performed within 14 days prior to study)
• Bilirubin < 3 times the upper limits of the institutional normal (performed within 14 days prior to study)
• International normalized ratio (INR) < 2 if off of anticoagulation (performed within 14 days prior to study) patients on anticoagulation therapy with an INR > 2 may be enrolled at the discretion of the investigator if they have not had any episodes of severe hemorrhage
• The subject must be deemed competent to give informed consent
• The subject must agree to use two effective forms of contraception beginning at least four (4) weeks prior to study entry, and continuing to do so for the duration of their participation in the study

Exclusion Criteria

• The subject has an implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias
• The subject has an infra-tentorial tumor or multifocal disease
• The subject has a history of hypersensitivity reaction to temozolomide or a history of hypersensitivity to dacarbazine (DTIC)
• The subject is receiving any other investigational agents; patient is allowed to get another investigational agent and to continue receiving the vaccine only if the disease progresses while in the study and the other investigational agent is a reasonable choice to treat the patient
• The subject has an active cancer being treated with chemotherapy at the time of screening
• The subject has a history of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), chronic hepatitis B or hepatitis C or is otherwise reasonably suspected to meet criteria for the diagnosis of a known congenital or acquired disorder causing systemic immunosuppression
• The subject has a history of, or is reasonably suspected to meet criteria for the diagnosis of a known congenital or acquired disorder causing systemic immunosuppression; or the subject is currently receiving any drug or supplement which is known to be associated with systemic immune suppression including those drugs which are prescribed for solid organ or stem cell transplant, autoimmune/inflammatory disorders, or other related medical conditions
• The subject has a history of, or is reasonably suspected to meet criteria for the diagnosis of a systemic auto-immune/inflammatory disease or other autoimmune disorder with the exception of: vitiligo, diabetes or thyroid dysfunction
• The subject is unable to give informed consent
• The subject is a prisoner
• The subject is cognitively impaired, and unable to give informed consent
• The subject is pregnant, as defined by a presumptive sign of pregnancy such as missed menses or a positive pregnancy test
• The subject requires or is likely to require more than a 2-week course of corticosteroids of > 4 mg
• Note: The effects of the investigational product on the developing human fetus are unknown; female subjects of childbearing potential are required to have a negative qualitative serum pregnancy test at the time of enrollment and within twenty-four (24) hours prior to the first dose of the investigational product * Female subject of childbearing potential is defined as follows: ** Subject with regular menses ** Subject with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding ** Subject with history of tubal ligation * Female subject not of childbearing potential is defined as follows: ** Subject who has undergone hysterectomy and/or bilateral oophorectomy ** Subject who is post-menopausal, which is defined as amenorrhea for at least one (1) year in a female subject who is greater than forty-five (> 45) years old