Tumor Treating Fields (TTFields) Therapy to Manage Brain Metastases in Small Cell Lung Cancer

Phase 2

Terminated

Conditions: Stage IA1 Lung Cancer AJCC v8
Stage II Lung Cancer AJCC v8
Stage IIB Lung Cancer AJCC v8
Stage IIIC Lung Cancer AJCC v8
Extensive Stage Lung Small Cell Carcinoma
Stage IIIA Lung Cancer AJCC v8
Limited Stage Lung Small Cell Carcinoma
Stage I Lung Cancer AJCC v8
Stage IA2 Lung Cancer AJCC v8
Stage IA3 Lung Cancer AJCC v8

Interventions: Other: Questionnaire Administration
Device: Tumor Treating Fields Therapy

Registration Number: NCT03995667

Lead Sponsor: OHSU Knight Cancer Institute

Brief Summary: This phase II single-arm pilot study will evaluate the safety and preliminary efficacy of Optune-Tumor Treating Fields (TTFields) therapy as a prophylactic approach to reducing small cell lung cancer (SCLC) that has spread to the brain (brain metastases). Optune is a portable battery powered device that produces alternating electrical fields, termed tumor treatment fields ("TTFields") within the human body. These TTFields are applied to the patient by electrically insulated surface transducer arrays, which function to disrupt the rapid cell division of cancer cells.

Detailed Description: PRIMARY OBJECTIVE:

I. Observed rate of brain metastases following TTFields therapy at 6 months.

SECONDARY OBJECTIVES:

I. Observed rate of brain metastases following TTFields therapy at 12 months. II. Survival of participants with SCLC after using TTFields therapy. III. Usage and overall safety characteristics of TTFields therapy. IV. Quality of life among participants using TTFields therapy. V. Observed rate of SCLC brain metastases at 6 months from the beginning of the 4th cycle of chemotherapy to development of brain metastases.

OUTLINE:

Participants will receive TTFields therapy on a continuous basis (i.e., 18-24 hours a day, 7 days a week) for a period of 12 months or until the development of brain metastases, whichever comes first. Participants will be able to carry the device in an over-the-shoulder bag or backpack so that they can receive continuous at-home treatment. The investigator or other designated healthcare provider will provide detailed instructions regarding the placement/replacement and positioning of the transducer arrays on the participants head. TTFields are applied to the shaved scalp via two pairs of orthogonally positioned transducer arrays. Each pair of transducer arrays will be centered on the participants shaved head such that one pair is placed on the left and right side of the head, and the second pair placed anteriorly and posteriorly. Transducer arrays should be replaced every 2 to 3 days, with a slight relocation of the new arrays \~2 cm from the prior location.

After completion of study treatment, patients are followed up periodically.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 3

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document
Pathologically confirmed limited stage (LS)-SCLC or extensive stage (ES)-SCLC
- LS-SCLC - stage I-III (Tany, Nany, M0) that can be safely treated with radiation doses. Excludes T3-4 due to multiple nodules that are too extensive of have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan
- ES-SCLC - stage IV (Tany, Nany, M1), or T3-4 due to multiple nodules that are too extensive of have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan
Must be no more than 6 weeks from having received last dose of chemo- and/or radiotherapy for primary tumor to anticipated start of TTField therapy
Partial response to standard of care (chemo- and/or radiotherapy) as judged by treating physicians with no evidence of recurrence as observed by thoracoabdominal computed tomography (CT) within 12 weeks of enrollment
No brain metastases as observed by gadolinium (gd)-magnetic resonance imaging (MRI) within 12 weeks of enrollment
No previous or currently active second malignancy, with exception of non-metastatic prostate cancer, treated stage I breast cancer, skin malignancies
Life expectancy of at >= 3 months
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60)
Participants must be willing and able to fully comply with the minimum required 18 hours/day of TTField therapy
Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation

Exclusion Criteria

Malignant disease, other than that being treated in this study, with exception of non-metastatic prostate cancer, treated stage I breast cancer, skin malignancies
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)
- External medical devices (e.g., insulin pumps) are permitted
Skull defect (e.g. missing bone with no replacement)
Shunt
Bullet fragments
Evidence of increased intracranial pressure (midline shift > 5 mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
Sensitivity to conductive hydrogels
Pregnant or lactating women
Underlying serious skin condition on the scalp, which in the opinion of the investigator, would prevent or interfere with TTField therapy
Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of participant safety or study results

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prevention (TTFields therapy, questionnaire)	Tumor Treating Fields Therapy	Patients undergo TTFields therapy over 18-24 hours daily. Cycles repeat every 4 weeks for 12 months in the absence of disease progression or unacceptable toxicity.
Prevention (TTFields therapy, questionnaire)	Questionnaire Administration	Patients undergo TTFields therapy over 18-24 hours daily. Cycles repeat every 4 weeks for 12 months in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Incidence of Small Cell Lung Cancer (SCLC) Brain Metastases at 6 Months	6 months following start of tumor treating fields (TTFields) therapy

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Death or last follow up following start of TTFields therapy, whichever comes first (assessed at 6, 12, 24, 36 and 60 months)	Overall survival of participants with SCLC after using TTFields therapy. The distribution of overall survival will be graphically described using Kaplan-Meier plot, for all subjects together, and for each disease group (extensive stage and limited stage).
Incidence of SCLC Brain Metastases at 12 Months	12 months following start of TTFields therapy
Incidence of TTfield Related Adverse Events	Continuously following start of TTFields therapy (up to 12 months)
Incidence of Cognitive Adverse Events (AEs) Using Mini Mental State Exam (MMSE)	Continuously following start of TTFields therapy (up to 12 months)	Incidence of cognitive AEs will be assessed by measuring changes in MMSE scores over time. Descriptive statistical analysis will be conducted.
Change in Quality of Life Over Time: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30)	6 and 12 months following start of TTFields therapy	Quality of life (QoL) among participants using TTFields therapy evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30). The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). For questions 29 and 30, a 7-points scale is used. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Summary of QoLs and its change over time will be presented graphically.
Incidence of SCLC Brain Metastases	Up to 180 days from Day 1 of the 4th cycle of chemotherapy (each cycle is 28 days)