Clinical Trials Roundup: May 2017
by Marlon Saria
We are pleased to announce a new clinical trial this month using the revolutionary Optune device. Recent data published by Dr. Santosh Kesari supports early initiation and continued use of Optune in combination with standard systemic therapies for the treatment of Glioblastoma multiforme (GBM). In addition we have several ongoing trials in ischemic and hemorrhagic stroke and quality & outcomes research as well as brain cancer. Please contact our centers for eligibility criteria.
* NEWLY OPENED CLINICAL TRIAL *
The purpose of this study is to test the effectiveness and safety of the NovoTTF- 200A device in patients with low-grade glioma when it’s used by itself or used together with temozolomide.
NovoTTF-200A is a device that produces alternating electrical fields within the human body that disrupt cell division. These very low intensity intermediate frequency electric fields (TTFields) impair the growth of tumor cells through the arrest of cell division and inducing apoptosis.
ACTIVELY RECRUITING CLINICAL TRIALS
Primary Brain Cancer
ImmunoCellular (PDF): A Phase III Randomized Double-Blind, Controlled Study of ICT-107 with Maintenance Temozolomide (TMZ) in Newly Diagnosed Glioblastoma following Resection and Concomitant TMZ Chemoradiotherapy (NCT02546102)
Medicenna Therapeutics, Inc. (PDF): An Open-Label Non-Randomized, Multi-Center Phase-2 Study of Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Glioblastoma at First Recurrence or Progression (NCT02858895)
See news clip about MDNA55 from abc7 news.
Orbus Therapeutics (PDF): A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy (NCT02796261)
Eli Lilly and Company (PDF): A Phase 2 Study of Abemaciclib in Patients With Brain Metastases Secondary to Hormone Receptor Positive Breast Cancer, Non-small Cell Lung Cancer, or Melanoma (NCT02308020)
Kadmon (PDF): Study of Tesevatinib in Subjects With Non-Small Cell Lung Cancer, EGFR Activating Mutation, Prior Treatment With a Tyrosine Kinase Inhibitor, and Brain Metastases or Leptomeningeal Metastases (NCT02616393)
Incyte Corporation: A Platform Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of Pembrolizumab + INCB Combinations in Advanced Solid Tumors (NCT02646748)
SanBio, Inc. / Sunovion (PDF): A Double-Blind, Controlled Phase 2b Study of the Safety and Efficacy of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke (NCT02448641)
National Space Biomedical Research Institute (NSBRI) (PDF): Validation of a Cephalad Fluid Shift Countermeasure: Selection of Optimal Cuff Design Followed by ICP Measurements During Extended Cuff Application: A Study in Collaboration with the National Space Biomedical Research Institute (NSBRI) and National Aeronautics and Space Administration (NASA) (NCT03097523)
See the abc7 news clip about this study.
We are currently conducting a feasibility study to determine optimal thigh cuff design using a cephalad fluid shift protocol in patients who have an intraventricular catheter (such as Ommaya reservoir) placed for the delivery of central nervous system chemotherapy or for diagnosing potential elevation of ICP. This study is in collaboration with Dr. Brandon Macias, scientist from NSBRI who is testing a device that will prevent visual impairment and intracranial pressure (VIIP) syndrome in astronauts involved in long duration space flights on the International Space Station. The current study explores a number of physiologic variables that may impact vision changes that have been reported in more than half of American astronauts after long duration space flights.
Quality and Outcomes Research
About the Author
Marlon Garzo Saria, PhD, RN, AOCNS, FAAN, is an oncology clinical nurse specialist and nurse scientist for the Inpatient Oncology and Caritas concierge suites at Providence Saint John’s Health Center in Santa Monica, California. He is an Assistant Professor of Neurosciences and Neurotherapeutics and Director of the Center for Quality Outcomes and Research at Pacific Neuroscience Institute and Saint John’s Cancer Institute. Dr. Saria serves in the Nurse Corps of the U.S. Air Force Reserve as a flight commander in the Aerospace Medical Squadron. He was inducted as a Fellow of the American Academy of Nursing in 2014.
Last updated: September 9th, 2019