Clinical Trials Roundup: April 2017

We are pleased to present our updated roster of clinical trials this month. We have broadened our reach to encompass studies in ischemic and hemorrhagic stroke and quality & outcomes research as well as brain cancer. Please contact us for eligibility criteria.

Newly Opened Clinical Trials

GLIOBLASTOMA

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)

Saint John’s Cancer Institute at Providence Saint John’s Health Center is excited to announce its participation in a clinical trial of MDNA55 in adults with recurrent Glioblastoma where MDNA55 is administered directly into the tumor by a single infusion. MDNA55 is a targeted therapy, designed to attack only tumor cells, leaving healthy tissue unaffected. It may also help the immune system to recognize and attack the tumor. The study aims to assess the risks and possible benefits of MDNA55 treatment.

The trial here will be led by Principal Investigator, Dr. Achal Achrol, Director of Neurovascular Surgery and Neurocritical Care at the Pacific Neuroscience Institute and Chief of the Glioma Surgery Program at the Saint John’s Cancer Institute at Providence Saint John’s Health Center.

Interestingly, Saint John’s Cancer Institute was home to the very first clinical study of MDNA55 in 1997 under the leadership of Dr. Robert Rand. This first clinical study of MDNA55 aimed to evaluate safety and anti-tumor activity of different doses injected directly into the tumors of 9 subjects with recurrent Glioblastoma. Promising results from this initial trial led in 1999 to the technology being licensed to a California based company who continued clinical development. To date a total of 72 adults have received intra-tumoral administration of MDNA55.

 

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)

 

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)

Dr. Steve O’Day announces a Phase I/II clinical trial across all Solid Tumors with Pembrolizamab / Keytruda (anti-PD1). The trial combines Pembro with either of two experimental drugs, (1) JAK1 inhibitor or (2) PI3K Inhibitor. Both drugs have microenvironment effects that are immune-stimulatory and appear to synergize with PD1 blockade. Both are oral once a day drugs with good safety profile to date.

Any solid tumor patient that has failed standard of care or in intolerant of standard of care treatment or refuses standard of care treatment for any reason is eligible. Patients can be naïve to PD1 or PDL1 inhibitor therapy or have received PD1 or PDL1 inhibitor therapy and progressed (but did not stop PD1 for toxicity reasons). Metasatatic Colon Cancer needs to be mismatch repair deficient; Metastatic Breast needs to be Triple Negative; Patients have to have evaluable target lesions and ECOG PS 0-1; Any number of prior regimens ok; and CNS lesions have to be treated and 4 week washout without new lesions.

 

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)

This is a double-blind, sham-surgery controlled study of stereotactic, intracranial injection of SB623 cells in patients with fixed motor deficits from ischemic stroke. SB623 cells are bone-marrow-derived stromal cells that have been transiently transfected with the intercellular domain of the human Notch-1 gene.

 

Actively Recruiting Studies

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 withMaintenance Temozolomide (TMZ) in Newly Diagnosed Glioblastoma following Resection andConcomitant TMZ Chemoradiotherapy (NCT02546102) 

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 METASTATIS

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)

 

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)

View a news clip from KABC-TV Los Angeles.

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 Trials 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

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

 

Marlon Garzo Saria, PhD, RN, is director of the Center for Quality Outcomes and Research (CQOR) in the Department of Translational Neurosciences and Neurotherapeutics and assistant professor at the Saint John’s Cancer Institute. In addition, he is an advanced practice registered nurse at Pacific Neuroscience Institute, Providence Saint John’s Health Center.