Brain Metastasis, Small Cell Lung Cancer
Conditions
Keywords
Cancer, Brain, Lung, Small-cell
Brief summary
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.
Interventions
DEVICENovoTTF-100A plus chemotherapy
NovoTTF-100A System with Physician's Choice Chemotherapy
Sponsors
John Villano
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to treatment failure | Up to 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 2 years | As a measure of safety and tolerability |
Countries
United States
Outcome results
None listed