Tumor-Treating Fields Therapy in Preventing Brain Tumors in Participants With Extensive-Stage Small Cell Lung Cancer

Study Purpose

This trial studies how well tumor-treating fields therapy works in preventing brain tumors in participants with small cell lung cancer that has spread to other places in the body. Tumor-treating fields therapy involves the use of the NovoTTF-200A which delivers alternating electrical fields, or tumor treating fields, through ceramic discs placed on the head. This electric force may slow and/or reverse tumor growth by disrupting the way cancer cells grow.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 22 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Life expectancy of > 3 months - Histologically proven extensive stage small cell lung carcinoma (ES-SCLC) (any T any N and any M stage) within 6 months prior to start of study treatment with the NovoTTF-200A, with a partial or complete response to at least four cycles of first-line chemotherapy - Karnofsky performance status (KPS) > 70 - Neutrophil count > 1.5 x 10^9/L - Platelet count > 100 x 10^9/L - Bilirubin < 1.5 x upper limit of normal (ULN) - Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) < 2.5 x ULN or < 5 x ULN if patient has documented liver metastases - Serum creatinine < 1.5 x ULN

    Exclusion Criteria:

    - Evidence of brain metastases on magnetic resonance imaging (MRI) of brain with and without contrast - History of other prior malignancy within the past 5 years except for superficial skin cancers - No severe comorbidities: - History of significant cardiovascular disease unless the disease is well controlled.
Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea)
  • - History of arrhythmia that is symptomatic or requires treatment.
Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial - History of cerebrovascular accident (CVA) within 6 months prior to start of study treatment - Active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol therapy - History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent - Active implantable electronic medical devices in the brain; a skull defect, a shunt, or bullet fragments - Known allergies to medical adhesives or hydrogel - Unable to operate the NovoTTF-200A device independently or with the help of a caregiver - If a female, currently pregnant, breastfeeding, or unwilling to avoid pregnancy while on study treatment - Concurrent brain directed therapy (beyond NovoTTF-200A as per protocol) - Prior clinical trial participation with brain directed therapy - Concurrent treatment clinical trials

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03607682
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Albert Attia
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Albert Attia, MD
Principal Investigator Affiliation Vanderbilt-Ingram Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Extensive Stage Small Cell Lung Carcinoma
Additional Details

PRIMARY OBJECTIVES:

  • I. To measure the feasibility and compliance of NovoTTF-200A as prophylactic cranial tumor treatment fields (TTF) therapy, determined by percent (%) of patients continuing TTF therapy until intracranial tumor progression, discontinuation due to dose limiting toxicity (DLT), or 6 months.
SECONDARY OBJECTIVES:
  • I. To evaluate time to intracranial failure after NovoTTF-200A.
  • II. To evaluate overall survival after NovoTTF-200A.
  • III. To evaluate the rates of intracranial failure at 2, 4, 6, 8, 10, 12 months after NovoTTF-200A.
  • IV. To evaluate intracranial failure free survival after NovoTTF-200A.
  • V. To evaluate the rate of decline in Hopkins Verbal Language Test-Revised (HVLT-R) free recall, delayed recall and delayed recognition, Controlled Oral Word Association Test (COWAT) and Trail Making Test (TMT) Parts A and B at 2, 4, 6, 8, 10, 12 months after NovoTTF-200A.
  • VI. To evaluate time to neurocognitive failure after NovoTTF-200A.
  • VII. To evaluate neurocognitive failure-free survival after NovoTTF-200A.
  • VIII. To evaluate quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC Quality of life Questionnaire C30) with BN20 addendum after NovoTTF-200A.
  • IX. To assess adverse events, severity, and frequency associated with NovoTTF-200A using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
OUTLINE: Participants undergo tumor-treating fields therapy using the NovoTTF-200A device over 18 hours per day for a minimum of 4 weeks and up to 1 year in the absence of disease progression, unacceptable toxicity, or intracranial failure. After completion of study treatment, participants are followed up at 8 weeks.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232

Site Contact

Clinical Trials Information Program

cip@vanderbilt.edu

800-811-8480

Winston-Salem, North Carolina

Status

Recruiting

Address

Wake Forest Baptist Health Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157

Site Contact

Alexandra Bolick, BS, MBA

cip@vanderbilt.edu

336-713-7683

Johns Hopkins Suburban Hospital, Bethesda, Maryland

Status

Recruiting

Address

Johns Hopkins Suburban Hospital

Bethesda, Maryland, 20817

Site Contact

Barbara Squiller, RN, MSN

cip@vanderbilt.edu

301-896-2719

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