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.
- 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.
- 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
- 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).
- 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
John L Villano, MD, PhD
Lucille P. Markey Cancer Center at University of Kentucky