Clinical Trials Roundup: May 2017

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 *

NovoCure, Ltd. (PDF) A Single-Center, Open-Label, Randomized Phase II Study of NovoTTF-200A Alone and Combined With Temozolomide in Patients With Low-Grade Gliomas (NCT02507232)

 

ACTIVELY RECRUITING CLINICAL TRIALS

Primary Brain Cancer

AbbVie / RTOG (PDF): A Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (NCT02646748)

Boehringer Ingelheim (PDF): A Phase I Dose Escalation and CNS Pharmacokinetic Study of the ErbB Family Inhibitor Afatinib in Patients with Recurrent or Progressive Brain Cancer (NCT02423525)

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.

 

Nativis (PDF): A Feasibility Study of the Nativis Voyager System in Patients With Recurrent Glioblastoma Multiforme (GBM)(NCT02296580)

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)

Triphase MRZ-108 (PDF): Phase 2 Trial of Single Agent Marizomib in Progressive or Recurrent Grade IV Malignant Glioma(NCT02330562)

Triphase MRZ-112 (PDF): Study of Marizomib With Temozolomide and Radiotherapy in Patients With Newly Diagnosed Brain Cancer(NCT02903069)

 

Brain Metastasis

Boehringer Ingelheim (PDF): A Phase I Dose Escalation and CNS Pharmacokinetic Study of the ErbB Family Inhibitor Afatinib in Patients with Recurrent or Progressive Brain Cancer (NCT02423525)

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)

EpiCentRX (PDF): Dose-Escalation Study of RRx-001 in Combination With Whole Brain Radiation in Subjects With Brain Metastases (BRAINSTORM) (NCT02215512)

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)

 

Solid Tumors

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)

 

Stroke

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)

                                                                                                                                         

Other Studies

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

CancerLife (PDF): Evaluation of a Mobile Digital Solution for Cancer Care and Research: A Feasibility Study (NCT03094741)

 

For more information, please click the hyperlinks or contact the Neuro-Oncology Clinical Trial Team at: neuro.oncology@jwci.org  |  310-829-8265  |  clinical trials website

 

Investigators:
Achal S. Achrol, MD
Garni Barkhoudarian, MD
Daniel Kelly, MD
Santosh Kesari MD, PhD, FANA, FAAN
Steven O’Day, MD
Marlon Garzo Saria, PhD, RN, AOCNS, FAAN

Clinical Trials Team:
Najee Boucher, CRA
Jaya M. Gill, RN., BSN
Annie Heng, RN, BSN
Tiffany Juarez, PhD
Marlon Garzo Saria, PhD, RN, AOCNS, FAAN