Tumor Treating Fields (TTFields) Therapy to Manage Brain Metastases in Small Cell Lung Cancer
Condition: 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
MeSH terms: Carcinoma; Lung Neoplasms; Small Cell Lung Carcinoma; Carcinoma, Small Cell
Intervention: Questionnaire Administration; Tumor Treating Fields Therapy
Intervention description: Ancillary studies; Optune-Tumor Treating Fields (TTFields). Transducer arrays affixed to scalp, worn continuously.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 22 Years
Healthy volunteers: No

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.
    

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