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

NCT02425072 | Withdrawn Phase 2 DMC

• 1 other identifier: 14-NEURO-05-MCC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Cancer; Brain; Lung; Small-cell

Outcome Measures

Primary Outcomes (1)

• Time to treatment failure

  Up to 3 months

Secondary Outcomes (4)

• 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

Study Arms (1)

NovoTTF-100A plus chemotherapy

EXPERIMENTAL

NovoTTF-100A System with Physician's Choice Chemotherapy

Device: NovoTTF-100A plus chemotherapy

Interventions

NovoTTF-100A plus chemotherapy DEVICE

NovoTTF-100A System with Physician's Choice Chemotherapy

NovoTTF-100A plus chemotherapy

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• John Villano: lead

Study Sites (1)

University of Kentucky, Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Brain Neoplasms; Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• John L Villano, MD, PhD

  Lucille P. Markey Cancer Center at University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: April 23, 2015
• Study Start: April 1, 2016
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2022
• Last Updated: August 10, 2017

Record last verified: 2017-08

Locations

US (1)