Effect of NovoTTF-100A in Recurrent Glioblastoma Multiforme (GBM)

Inclusion Criteria:

• Pathological evidence of GBM using WHO classification criteria.
• > 18 years of age.
• Not a candidate for further radiotherapy or additional resection of residual tumor.
• Patients with disease progression (by Macdonald criteria i.e., > 25% or new lesion) documented by CT or MRI within 4 weeks prior to enrollment
• Karnofsky scale ≥ 70
• Life expectancy at least 3 months
• Participants of childbearing age must use effective contraception.
• All patients must sign written informed consent.

Exclusion Criteria:

• Actively participating in another clinical treatment trial
• Within 4 weeks from surgery for recurrence
• Within 4 weeks from any prior chemotherapy.
• Within 4 weeks from radiation therapy
• Pregnant

• Significant co-morbidities (within 4 weeks prior to enrollment):

  1. Significant liver function impairment - AST or ALT > 3 times the upper limit of normal
  2. Total bilirubin > upper limit of normal
  3. Significant renal impairment (serum creatinine > 1.7 mg/dL)
  4. Coagulopathy (as evidenced by PT or APTT >1.5 times control in patients not undergoing anticoagulation)
  5. Thrombocytopenia (platelet count < 100 x 103/μL)
  6. Neutropenia (absolute neutrophil count < 1 x 103/μL)
  7. Anemia (Hb < 10 g/L)
  8. Severe acute infection
• Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias.
• Infra-tentorial tumor
• Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)