NOVOTTF-200A for the Treatment of Recurrent WHO Grade III Malignant Astrocytoma

Inclusion Criteria

• Understand and voluntarily sign and date an informed consent document before any study related assessments/procedures are conducted
• All subjects must have histologic evidence of grade 3 (G3) malignant astrocytoma (MG) and radiographic evidence of recurrence or disease progression (defined as either a greater than 25% increase in the largest bi-dimensional product of enhancement, a new enhancing lesion or a significant increase in T2 fluid attenuated inversion recovery [FLAIR])
• Subjects with archival tumor tissue suitable for genetic testing must give permission to access and test the tissue; subjects without archival tumor tissue are eligible
• No prior treatment with bevacizumab (BEV) or any anti-angiogenesis agents
• At least 4 weeks from surgical resection and 12 weeks from end of radiotherapy prior to enrollment in this study, unless relapse is confirmed by tumor biopsy or new lesion outside of radiation field, or if there are two magnetic resonance imaging (MRIs) confirming progressive disease that are 8 weeks apart
• All adverse events (AEs) resulting from prior chemotherapy, surgery or radiotherapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) (version [v.] 4.03) grade =< 1 (except for laboratory parameters outlined below)
• Hemoglobin >= 9 g/dL (within 7 days prior to NOVOTTF-200A administration [transfusions and/or growth factor support may be used at the discretion of the Investigator during screening])
• Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (within 7 days prior to NOVOTTF-200A administration [transfusions and/or growth factor support may be used at the discretion of the Investigator during screening])
• Platelet count >= 100 x 10^9/L (within 7 days prior to NOVOTTF-200A administration [transfusions and/or growth factor support may be used at the discretion of the Investigator during screening])
• Serum bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN if Gilbert’s disease is documented (within 7 days prior to NOVOTTF-200A administration [transfusions and/or growth factor support may be used at the discretion of the Investigator during screening])
• Aspartate transaminase (AST) =< 2.5 ULN (within 7 days prior to NOVOTTF-200A administration [transfusions and/or growth factor support may be used at the discretion of the Investigator during screening])
• Serum creatinine =< 1.5 x ULN (within 7 days prior to NOVOTTF-200A administration [transfusions and/or growth factor support may be used at the discretion of the Investigator during screening])
• Karnofsky performance status (KPS) score >= 70%
• Willing and able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria

• The presence of 1p19q loss of heterozygosity (LOH) which is diagnostic for anaplastic oligodendroglioma (AO)
• Co-medication that may interfere with study results, e.g., immunosuppressive agents other than corticosteroids. (Steroid therapy for control of cerebral edema is allowed at the discretion of the investigator. Subjects should be on a stable dose of steroids for at least 1 week prior to study beginning.)
• Chemotherapy administered within 4 weeks (6 weeks for an intravenous [IV] nitrosoureas and 12 weeks for an implanted nitrosoureas wafer) prior to day 1 of study treatment
• Pregnancy or breastfeeding
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics & psychiatric illness/social situations that would limit adherence with study requirements, or disorders associated with significant immunocompromised state
• Known previous/current malignancy requiring treatment within =< 3 years except for cervical carcinoma in situ, squamous or basal cell skin carcinoma and superficial bladder carcinoma
• Any comorbid condition that confounds the ability to interpret data from the study as judged by the investigator