NovoTTF-100A Therapy for Refractory CNS Involved Small Cell Lung Cancer

Inclusion Criteria:

Histologically confirmed small cell lung cancer histology with CNS metastases
Parenchymal disease, ten or less lesions, and supratentorial
PS 70% or greater
Prior CNS radiotherapy.
No previous or currently active second malignancy
Age > 22 years.
Life expectancy of ≥ 3 months.

Exclusion Criteria:

Significant liver function impairment - AST or ALT > 3 times the upper limit of normal; Total bilirubin > upper limit of normal.
Significant renal impairment (serum creatinine > 1.7 mg/dL).
Coagulopathy (as evidenced by PT or APTT >1.5 times in control patients not undergoing anticoagulation).Thrombocytopenia (platelet count < 100 x 103/μL).
Neutropenia (absolute neutrophil count < 1 x 103/μL).
Anemia (Hb < 10 g/L).
Severe acute infection. Serious non-healing wound or ulcer on scalp
Significant co-morbidities within 4 weeks prior to enrollment.
Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias.
Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmable shunts).
Skull defect (e.g. missing bone with no replacement).
Shunt
Bullet fragments
Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness).
Sensitivity to conductive hydrogels.
Pregnant or lactating women