Clinical trial NCT03995667: Tumor Treating Fields (TTFields) Therapy to Manage Brain Metastases in Small Cell Lung Cancer
Official title: Prophylactic Tumor Treating Fields in Management of Patients With Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
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
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: NovoCure Ltd.
name: Oregon Health and Science University
First posted: 2019-06-24
Enrollment: 3
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of Small Cell Lung Cancer (SCLC) Brain Metastases at 6 Months
timeFrame: 6 months following start of tumor treating fields (TTFields) therapy
Secondary outcomes:
measure: Incidence of SCLC Brain Metastases at 12 Months
timeFrame: 12 months following start of TTFields therapy
measure: Overall Survival
timeFrame: Death or last follow up following start of TTFields therapy, whichever comes first (assessed at 6, 12, 24, 36 and 60 months)
measure: Incidence of TTfield Related Adverse Events
timeFrame: Continuously following start of TTFields therapy (up to 12 months)
measure: Incidence of Cognitive Adverse Events (AEs) Using Mini Mental State Exam (MMSE)
timeFrame: Continuously following start of TTFields therapy (up to 12 months)
measure: Change in Quality of Life Over Time: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30)
timeFrame: 6 and 12 months following start of TTFields therapy
measure: Incidence of SCLC Brain Metastases
timeFrame: Up to 180 days from Day 1 of the 4th cycle of chemotherapy (each cycle is 28 days)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Hospital in Arizona
state: Arizona
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Timur Mitin, MD
role: PRINCIPAL_INVESTIGATOR
References: