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

Study Overview
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Brief Summary
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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.

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

Conditions
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Small Cell Lung Cancer, Brain Metastasis

Intervention / Treatment
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* Device: NovoTTF-100A plus chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NovoTTF-100A plus chemotherapy<br>NovoTTF-100A System with Physician's Choice Chemotherapy | Device: NovoTTF-100A plus chemotherapy<br>* NovoTTF-100A System with Physician's Choice Chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to treatment failure |  | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | Up to 6 months | 
| Overall response rate |  | Up to 2 years | 
| Duration of response |  | Up to 2 years | 
| Safety of treatment assessed by number of participants with adverse events | As a measure of safety and tolerability | Up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Brain, Lung, Small-cell