Study Of NOVOTTF-200A In Bevacizumab-Naive Subjects With Recurrent Grade III Malignant Astrocytoma

Inclusion Criteria

• •1. Understand and voluntarily sign and date an informed consent document before any study related assessments/procedures are conducted.
• •2. Males and females of age ≥18 years at the time of the signing of the informed consent document.
• •3. All subjects must have histologic evidence of G3 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 FLAIR).
• •4. 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.
• •5. No prior treatment with BEV or any anti-angiogenesis agents.
• •6. 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 MRIs confirming progressive disease that are 8 weeks apart.
• •7. All AEs resulting from prior chemotherapy, surgery or radiotherapy must have resolved to NCI-CTCAE (v. 4.03) Grade ≤1 (except for laboratory parameters outlined below).
• •8. Laboratory results 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):
• •* Hemoglobin ≥9 g/dL.
• •* Absolute neutrophil count (ANC) ≥1.5 × 109/L.
• •* Platelet count ≥100 × 109/L.
• •* Serum bilirubin ≤1.5 × upper limit of normal (ULN) or ≤3 × ULN if Gilbert's disease is documented.
• •* Aspartate transaminase (AST) ≤ 2.5 ULN.
• •* Serum creatinine ≤1.5 × ULN.
• •9. Karnofsky Performance Status (KPS) score ≥70%.
• •10. Willing and able to adhere to the study visit schedule and other protocol requirements.