- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02425072
NovoTTF-100A Therapy for Refractory CNS Involved Small Cell Lung Cancer
August 8, 2017 updated by: John Villano
NovoTTFTM-100A System Therapy for Refractory CNS Involved Small Cell Lung Cancer
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- University of Kentucky, Markey Cancer Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NovoTTF-100A plus chemotherapy
NovoTTF-100A System with Physician's Choice Chemotherapy
|
NovoTTF-100A System with Physician's Choice Chemotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to treatment failure
Time Frame: Up to 3 months
|
Up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate
Time Frame: Up to 2 years
|
Up to 2 years
|
|
Duration of response
Time Frame: Up to 2 years
|
Up to 2 years
|
|
Progression Free Survival
Time Frame: Up to 6 months
|
Up to 6 months
|
|
Safety of treatment assessed by number of participants with adverse events
Time Frame: Up to 2 years
|
As a measure of safety and tolerability
|
Up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John L Villano, MD, PhD, Lucille P. Markey Cancer Center at University of Kentucky
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (Anticipated)
July 1, 2021
Study Completion (Anticipated)
July 1, 2022
Study Registration Dates
First Submitted
December 11, 2014
First Submitted That Met QC Criteria
April 22, 2015
First Posted (Estimate)
April 23, 2015
Study Record Updates
Last Update Posted (Actual)
August 10, 2017
Last Update Submitted That Met QC Criteria
August 8, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Brain Neoplasms
Other Study ID Numbers
- 14-NEURO-05-MCC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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