WithdrawnPhase 2NCT02425072

NovoTTF-100A 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.

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

StatusWithdrawn
PhasePhase 2
U.S. locations1
SponsorJohn Villano
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.

03
Public criteria

Who may be able to participate

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

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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