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

Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02425072
• Other study ID #: 14-NEURO-05-MCC
• Status: Withdrawn
• Phase: Phase 2
• First received: December 11, 2014
• Last updated: August 8, 2017
• Start date: April 2016
• Est. completion date: July 2022

Study information

• Verified date: August 2017
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2022
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastasis
• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Device:
• NovoTTF-100A plus chemotherapy
NovoTTF-100A System with Physician's Choice Chemotherapy

Locations

Country	Name	City	State
United States	University of Kentucky, Markey Cancer Center	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
John Villano

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to treatment failure		Up to 3 months
Secondary	Progression Free Survival		Up to 6 months
Secondary	Overall response rate		Up to 2 years
Secondary	Duration of response		Up to 2 years
Secondary	Safety of treatment assessed by number of participants with adverse events	As a measure of safety and tolerability	Up to 2 years