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

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byTimur Mitin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: OHSU Knight Cancer Institute

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Timur Mitin, MD

Principal Investigator

OHSU Knight Cancer Institute

Eligibility Criteria

Inclusion Criteria

Life expectancy of at >= 3 months

Ability to understand and the willingness to sign a written informed consent document

Pathologically confirmed limited stage (LS)-SCLC or extensive stage (ES)-SCLC

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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)

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Treatment Details

Interventions

Optune-Tumor Treating Fields (TTFields) therapy (Device)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Prevention (TTFields therapy, questionnaire)Experimental Treatment2 Interventions

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.