Expired Study
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Lexington, Kentucky 40536


Purpose:

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.


Criteria:

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


NCT ID:

NCT02425072


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

Lexington, Kentucky 40536
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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