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

Stopped early · Not applicable

Conditions studied: Extensive Stage Small Cell Lung Carcinoma

In brief

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.

Key facts

Study ID

NCT03607682

Run by

Vanderbilt-Ingram Cancer Center

People needed

2

Starts

2018-09-05

Expected to finish

2020-07-13

Last updated by the study team

2020-08-04

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.