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

NCT ID: NCT02425072

Last Updated: 2017-08-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2022-07-31

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.

Conditions

Small Cell Lung Cancer; Brain Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NovoTTF-100A plus chemotherapy

NovoTTF-100A System with Physician's Choice Chemotherapy

Group Type: EXPERIMENTAL

NovoTTF-100A plus chemotherapy

Intervention Type: DEVICE

NovoTTF-100A System with Physician's Choice Chemotherapy

Interventions

NovoTTF-100A plus chemotherapy

NovoTTF-100A System with Physician's Choice Chemotherapy

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

John Villano

OTHER

Sponsor Role: lead

Responsible Party

John Villano

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John L Villano, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lucille P. Markey Cancer Center at University of Kentucky

Locations

University of Kentucky, Markey Cancer Center

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

14-NEURO-05-MCC

Identifier Type: -

Identifier Source: org_study_id