Finding studies
Finding studies
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Lead
Vanderbilt-Ingram Cancer Center
With
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.
Age
22–any
Sex
ALL
Healthy volunteers
Not accepted
