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