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

NCT ID: NCT03995667

Last Updated: 2023-10-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-11
• Study Completion Date: 2022-08-04

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.

Conditions

Extensive Stage Lung Small Cell Carcinoma; Limited Stage Lung Small Cell Carcinoma; Stage I Lung Cancer AJCC v8; Stage IA1 Lung Cancer AJCC v8; Stage IA2 Lung Cancer AJCC v8; Stage IA3 Lung Cancer AJCC v8; Stage IB Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Stage IIA Lung Cancer AJCC v8; Stage IIB Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Prevention (TTFields therapy, questionnaire)

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.

Group Type: EXPERIMENTAL

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Tumor Treating Fields Therapy

Intervention Type: DEVICE

Optune-Tumor Treating Fields (TTFields). Transducer arrays affixed to scalp, worn continuously.

Interventions

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Tumor Treating Fields Therapy

Optune-Tumor Treating Fields (TTFields). Transducer arrays affixed to scalp, worn continuously.

Intervention Type: DEVICE

Other Intervention Names

Alternating Electric Field Therapy; TTF; TTFields

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NovoCure Ltd.

INDUSTRY

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Timur Mitin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timur Mitin, MD

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

OHSU Knight Cancer Institute

Portland, Oregon, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2020-00574

Identifier Type: REGISTRY

Identifier Source: secondary_id

STUDY00018029

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00018029

Identifier Type: -

Identifier Source: org_study_id