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WithdrawnPhase 2NCT02425072
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNovoTTF-100A plus chemotherapy

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC) · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 10, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Withdrawn

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?John Villano

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
John Villano
Interventions being studied
Device: NovoTTF-100A plus chemotherapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Small cell lung cancer (SCLC)→
Disease setting
Resistant or refractory→
Treatment approach
Chemotherapy→
Study topics
Brain metastases→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Kentucky, Markey Cancer CenterLexington, Kentucky

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 10, 2017. Always confirm current availability with the study team.

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