search
Back to results

Tumor-Treating Fields Therapy in Preventing Brain Tumors in Participants With Extensive-Stage Small Cell Lung Cancer

Primary Purpose

Extensive Stage Small Cell Lung Carcinoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tumor Treating Fields (TTF) Therapy
NovoTTF-200A Device
Quality-of-Life Assessment
Sponsored by
Vanderbilt-Ingram Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extensive Stage Small Cell Lung Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Life expectancy of > 3 months
  • Histologically proven extensive stage small cell lung carcinoma (ES-SCLC) (any T any N and any M stage) within 6 months prior to start of study treatment with the NovoTTF-200A, with a partial or complete response to at least four cycles of first-line chemotherapy
  • Karnofsky performance status (KPS) > 70
  • Neutrophil count > 1.5 x 10^9/L
  • Platelet count > 100 x 10^9/L
  • Bilirubin < 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) < 2.5 x ULN or < 5 x ULN if patient has documented liver metastases
  • Serum creatinine < 1.5 x ULN

Exclusion Criteria:

  • Evidence of brain metastases on magnetic resonance imaging (MRI) of brain with and without contrast
  • History of other prior malignancy within the past 5 years except for superficial skin cancers

  • No severe comorbidities:

    • History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea)
    • History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial
    • History of cerebrovascular accident (CVA) within 6 months prior to start of study treatment
    • Active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol therapy
    • History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent
  • Active implantable electronic medical devices in the brain; a skull defect, a shunt, or bullet fragments
  • Known allergies to medical adhesives or hydrogel
  • Unable to operate the NovoTTF-200A device independently or with the help of a caregiver
  • If a female, currently pregnant, breastfeeding, or unwilling to avoid pregnancy while on study treatment
  • Concurrent brain directed therapy (beyond NovoTTF-200A as per protocol)
  • Prior clinical trial participation with brain directed therapy
  • Concurrent treatment clinical trials

Sites / Locations

  • Vanderbilt-Ingram Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prevention (TTF therapy, NovoTTF-200A device)

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Patients Continuing Therapy Until Intracranial Tumor
Count of patients developed intracranial tumor divided by total number of patients.

Secondary Outcome Measures

Time to Intracranial Failure
Time to intracranial failure with death as a competing risk will be estimated using cumulative incidence function (CIF) and reported with a one-sided 95% confidence interval.
Overall Survival
Estimated using the Kaplan-Meier method.
Rate of Intracranial Failure
Estimated using the cumulative incidence function
Rate of Decline in Cognitive Function
Measured by Hopkins Verbal Language Test
Time to Neurocognitive Failure
Measured by Hopkins Verbal Language Test
Neurocognitive Failure-free Survival
Measured by Hopkins Verbal Language Test
Evaluate Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30
Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (scale 1-4)
Incidence of Adverse Events
Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Full Information

First Posted
July 11, 2018
Last Updated
July 17, 2020
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
NovoCure Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT03607682
Brief Title
Tumor-Treating Fields Therapy in Preventing Brain Tumors in Participants With Extensive-Stage Small Cell Lung Cancer
Official Title
A Multi-Institutional Pilot Study of Prophylactic Cranial Tumor-Treating Fields for Patients With Extensive-stage Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
PI left institution and loss of funding
Study Start Date
September 5, 2018 (Actual)
Primary Completion Date
June 2, 2020 (Actual)
Study Completion Date
July 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
NovoCure Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial studies how well tumor-treating fields therapy works in preventing brain tumors in participants with small cell lung cancer that has spread to other places in the body. Tumor-treating fields therapy involves the use of the NovoTTF-200A which delivers alternating electrical fields, or tumor treating fields, through ceramic discs placed on the head. This electric force may slow and/or reverse tumor growth by disrupting the way cancer cells grow.
Detailed Description
PRIMARY OBJECTIVES: I. To measure the feasibility and compliance of NovoTTF-200A as prophylactic cranial tumor treatment fields (TTF) therapy, determined by percent (%) of patients continuing TTF therapy until intracranial tumor progression, discontinuation due to dose limiting toxicity (DLT), or 6 months. SECONDARY OBJECTIVES: I. To evaluate time to intracranial failure after NovoTTF-200A. II. To evaluate overall survival after NovoTTF-200A. III. To evaluate the rates of intracranial failure at 2, 4, 6, 8, 10, 12 months after NovoTTF-200A. IV. To evaluate intracranial failure free survival after NovoTTF-200A. V. To evaluate the rate of decline in Hopkins Verbal Language Test-Revised (HVLT-R) free recall, delayed recall and delayed recognition, Controlled Oral Word Association Test (COWAT) and Trail Making Test (TMT) Parts A and B at 2, 4, 6, 8, 10, 12 months after NovoTTF-200A. VI. To evaluate time to neurocognitive failure after NovoTTF-200A. VII. To evaluate neurocognitive failure-free survival after NovoTTF-200A. VIII. To evaluate quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC Quality of life Questionnaire C30) with BN20 addendum after NovoTTF-200A. IX. To assess adverse events, severity, and frequency associated with NovoTTF-200A using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. OUTLINE: Participants undergo tumor-treating fields therapy using the NovoTTF-200A device over 18 hours per day for a minimum of 4 weeks and up to 1 year in the absence of disease progression, unacceptable toxicity, or intracranial failure. After completion of study treatment, participants are followed up at 8 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extensive Stage Small Cell Lung Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prevention (TTF therapy, NovoTTF-200A device)
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Tumor Treating Fields (TTF) Therapy
Intervention Description
Undergo TTF therapy
Intervention Type
Device
Intervention Name(s)
NovoTTF-200A Device
Intervention Description
Undergo TTF therapy
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Percentage of Patients Continuing Therapy Until Intracranial Tumor
Description
Count of patients developed intracranial tumor divided by total number of patients.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Time to Intracranial Failure
Description
Time to intracranial failure with death as a competing risk will be estimated using cumulative incidence function (CIF) and reported with a one-sided 95% confidence interval.
Time Frame
Up to 3 years
Title
Overall Survival
Description
Estimated using the Kaplan-Meier method.
Time Frame
Up to 3 years
Title
Rate of Intracranial Failure
Description
Estimated using the cumulative incidence function
Time Frame
Up to 12 months
Title
Rate of Decline in Cognitive Function
Description
Measured by Hopkins Verbal Language Test
Time Frame
Up to 12 months
Title
Time to Neurocognitive Failure
Description
Measured by Hopkins Verbal Language Test
Time Frame
Up to 3 years
Title
Neurocognitive Failure-free Survival
Description
Measured by Hopkins Verbal Language Test
Time Frame
Up to 3 years
Title
Evaluate Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30
Description
Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (scale 1-4)
Time Frame
Up to 3 years
Title
Incidence of Adverse Events
Description
Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Life expectancy of > 3 months Histologically proven extensive stage small cell lung carcinoma (ES-SCLC) (any T any N and any M stage) within 6 months prior to start of study treatment with the NovoTTF-200A, with a partial or complete response to at least four cycles of first-line chemotherapy Karnofsky performance status (KPS) > 70 Neutrophil count > 1.5 x 10^9/L Platelet count > 100 x 10^9/L Bilirubin < 1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) < 2.5 x ULN or < 5 x ULN if patient has documented liver metastases Serum creatinine < 1.5 x ULN Exclusion Criteria: Evidence of brain metastases on magnetic resonance imaging (MRI) of brain with and without contrast History of other prior malignancy within the past 5 years except for superficial skin cancers No severe comorbidities: History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea) History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial History of cerebrovascular accident (CVA) within 6 months prior to start of study treatment Active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol therapy History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent Active implantable electronic medical devices in the brain; a skull defect, a shunt, or bullet fragments Known allergies to medical adhesives or hydrogel Unable to operate the NovoTTF-200A device independently or with the help of a caregiver If a female, currently pregnant, breastfeeding, or unwilling to avoid pregnancy while on study treatment Concurrent brain directed therapy (beyond NovoTTF-200A as per protocol) Prior clinical trial participation with brain directed therapy Concurrent treatment clinical trials
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Attia, MD
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Tumor-Treating Fields Therapy in Preventing Brain Tumors in Participants With Extensive-Stage Small Cell Lung Cancer

We'll reach out to this number within 24 hrs