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

NCT03995667 | Terminated Phase 2 Results DMC FDA Device

• 2 other identifiers: STUDY00018029NCI-2020-00574
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Small Cell Lung Cancer (SCLC) Brain Metastases at 6 Months

  6 months following start of tumor treating fields (TTFields) therapy

Secondary Outcomes (6)

• Incidence of SCLC Brain Metastases at 12 Months

  12 months following start of TTFields therapy

• Overall Survival

  Death or last follow up following start of TTFields therapy, whichever comes first (assessed at 6, 12, 24, 36 and 60 months)

• 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)

• 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

Study Arms (1)

Prevention (TTFields therapy, questionnaire)

EXPERIMENTAL

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.

Other: Questionnaire Administration; Device: Tumor Treating Fields Therapy

Interventions

Questionnaire Administration OTHER

Ancillary studies

Prevention (TTFields therapy, questionnaire)

Tumor Treating Fields Therapy DEVICE

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

Also known as: Alternating Electric Field Therapy, TTF, TTFields

Prevention (TTFields therapy, questionnaire)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• NovoCure Ltd.: collaborator
• Oregon Health and Science University: collaborator

Study Sites (2)

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054, United States

Location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Due to very low accrual overall, no data was collected for the protocol outcomes.

Results Point of Contact

• Title: Dr. Timur Mitin, MD, PhD
• Organization: Oregon Health & Science University

mitin@ohsu.edu

503-494-8756

Study Officials

• Timur Mitin, MD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 24, 2019
• Study Start: June 11, 2019
• Primary Completion: August 4, 2022
• Study Completion: August 4, 2022
• Last Updated: October 30, 2023
• Results First Posted: October 30, 2023

Record last verified: 2023-10

Locations

US (2)