Tumor Treating Fields (TTFields) Therapy to Manage Brain Metastases in Small Cell Lung Cancer
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 30, 2023 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Prevention
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- OHSU Knight Cancer Institute
- Interventions being studied
- Other: Questionnaire Administration; Device: Tumor Treating Fields Therapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Mayo Clinic Hospital in ArizonaPhoenix, Arizona
- OHSU Knight Cancer InstitutePortland, Oregon
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 30, 2023. Always confirm current availability with the study team.