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

Primary Purpose

Small Cell Lung Cancer, Brain Metastasis

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

NovoTTF-100A plus chemotherapy

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Cancer, Brain, Lung, Small-cell

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Kentucky, Markey Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NovoTTF-100A plus chemotherapy

Arm Description

NovoTTF-100A System with Physician's Choice Chemotherapy

Outcomes

Primary Outcome Measures

Time to treatment failure

Secondary Outcome Measures

Progression Free Survival

Overall response rate

Duration of response

Safety of treatment assessed by number of participants with adverse events

As a measure of safety and tolerability

Full Information

NCT ID

NCT02425072

First Posted

December 11, 2014

Last Updated

August 8, 2017

Sponsor

John Villano

1. Study Identification

Unique Protocol Identification Number

NCT02425072

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Withdrawn

Why Stopped

slow accrual

Study Start Date

April 2016 (undefined)

Primary Completion Date

July 2021 (Anticipated)

Study Completion Date

July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

John Villano

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Cancer, Brain Metastasis

Keywords

Cancer, Brain, Lung, Small-cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NovoTTF-100A plus chemotherapy

Arm Type

Experimental

Arm Description

NovoTTF-100A System with Physician's Choice Chemotherapy

Intervention Type

Device

Intervention Name(s)

NovoTTF-100A plus chemotherapy

Intervention Description

NovoTTF-100A System with Physician's Choice Chemotherapy

Primary Outcome Measure Information:

Title

Time to treatment failure

Time Frame

Up to 3 months

Secondary Outcome Measure Information:

Title

Progression Free Survival

Time Frame

Up to 6 months

Title

Overall response rate

Time Frame

Up to 2 years

Title

Duration of response

Time Frame

Up to 2 years

Title

Safety of treatment assessed by number of participants with adverse events

Description

As a measure of safety and tolerability

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John L Villano, MD, PhD

Organizational Affiliation

Lucille P. Markey Cancer Center at University of Kentucky

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kentucky, Markey Cancer Center

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

12. IPD Sharing Statement

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

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