Small Cell Lung CancerPhase 2NCT02425072
NovoTTF-100A Therapy for Refractory CNS Involved Small Cell Lung Cancer
A Phase 2 study testing NovoTTF-100A plus chemotherapy in people with Small Cell Lung Cancer and Brain Metastasis, run by John Villano at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Small Cell Lung Cancer, Brain Metastasis
- What is being tested?
- NovoTTF-100A plus chemotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky, Markey Cancer Center
Lexington, Kentucky, 40536
About this study
Official title: 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.
- Conditions
- Small Cell Lung Cancer, Brain Metastasis
- Being tested
- NovoTTF-100A plus chemotherapy
- Keywords
- Cancer, Brain, Lung, Small-cell
- Medical subject headings
- Small Cell Lung Carcinoma, Brain Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovoTTF-100A plus chemotherapyDevice
NovoTTF-100A System with Physician's Choice Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| NovoTTF-100A plus chemotherapy | Experimental | NovoTTF-100A System with Physician's Choice Chemotherapy Receives: Device: NovoTTF-100A plus chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment failure
Measured: Up to 3 months
Secondary outcomes (4)
Progression Free Survival
Measured: Up to 6 months
Overall response rate
Measured: Up to 2 years
Duration of response
Measured: Up to 2 years
Safety of treatment assessed by number of participants with adverse events
As a measure of safety and tolerability
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startApr 2016
- Primary completionJul 2021 (estimated)
- Study completionJul 2022 (estimated)
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Villano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Villano, University of Kentucky
- Investigators
- John L Villano, MD, PhD, Principal investigator, Lucille P. Markey Cancer Center at University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425072
- Sponsor's protocol ID
- 14-NEURO-05-MCC
- Status last verified
- Aug 2017
- First submitted
- 11 Dec 2014
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NovoTTFTM-100A System Therapy for Refractory CNS Involved Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02425072
- Acronym / sponsor ID
- 14-NEURO-05-MCC
- Conditions
- Small Cell Lung Cancer, Brain Metastasis
- Keywords
- Cancer, Brain, Lung, Small-cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- John VillanoUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NovoTTF-100A plus chemotherapy | Experimental | Device: NovoTTF-100A plus chemotherapyNovoTTF-100A System with Physician's Choice Chemotherapy |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NovoTTF-100A plus chemotherapyNovoTTF-100A System with Physician's Choice Chemotherapy | Device | NovoTTF-100A plus chemotherapy |
Primary outcome
Time to treatment failure
Time frame: Up to 3 months
4 secondary outcomes
Progression Free Survival
Time frame: Up to 6 months
Overall response rate
Time frame: Up to 2 years
Duration of response
Time frame: Up to 2 years
Safety of treatment assessed by number of participants with adverse events
Time frame: Up to 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John L Villano, MD, PhD principal investigator
Lucille P. Markey Cancer Center at University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NovoTTF-100A plus chemotherapy in people with Small Cell Lung Cancer and Brain Metastasis, run by John Villano at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to treatment failure (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.