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

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

The hypothesis of this study is that the addition of NovoTTF-100A System treatment to salvage chemotherapy will significantly increase time to treatment failure in the brain of small cell lung cancer patients.

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