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

John Villano

Status and phase: Withdrawn; Phase 2

Conditions: Brain Metastasis; Small Cell Lung Cancer

Treatments: Device: NovoTTF-100A plus chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02425072

14-NEURO-05-MCC

Details and patient eligibility

About

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.

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

NovoTTF-100A plus chemotherapy

Experimental group

Description:

NovoTTF-100A System with Physician's Choice Chemotherapy

Treatment:

Device: NovoTTF-100A plus chemotherapy