Tumor-Treating Fields Therapy in Preventing Brain Tumors in Patients with Extensive-Stage Small Cell Lung Cancer
- 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
- 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 received 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
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.
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 QLQ 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.
Patients 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, patients are followed up at 8 weeks.
Trial Phase Phase NA
Trial Type Prevention
Vanderbilt University / Ingram Cancer Center
- Primary ID VICC THO 1747
- Secondary IDs NCI-2018-01428
- Clinicaltrials.gov ID NCT03607682