NovoTTF-100A Therapy for Refractory CNS Involved Small Cell Lung Cancer
Withdrawn before enrolling · Phase 2
Conditions studied: Small Cell Lung Cancer, Brain Metastasis
In brief
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.
Key facts
- Study ID
- NCT02425072
- Run by
- John Villano
- People needed
- 0
- Starts
- 2016-04-01
- Expected to finish
- 2022-07-01
- Last updated by the study team
- 2017-08-10
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University of Kentucky, Markey Cancer Center — Lexington, Kentucky, United States
Full record on ClinicalTrials.gov
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