Clinical Trials Round-Up: February 2017

Find out about our roster of clinical trials at the Pacific Neuroscience Research Center at Pacific Neuroscience Institute.

TRIALS OPEN FOR ENROLLMENT:

New Trial

National Space Biomedical Research Institute (NSBRI): Validation of a Cephalad Fluid Shift Countermeasure: Selection of Optimal Cuff Design Followed by Intra-Cranial Pressure (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).

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. For more information, download “Dear Doctor” letter.

ONGOING TRIALS:  

Primary Brain Tumor

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

AbbVie / RTOG (NCT02573324): A Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification. Download pdf flyer

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

Inspyr Therapeutics (NCT02876003): Efficacy, Safety and CNS Exposure of G-202 in Patients with PSMA-Positive Recurrent or Progressive Glioblastoma. Download pdf flyer

ImmunoCellular (NCT02546102): 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. Download pdf flyer

Nativis (NCT02296580): A Feasibility Study of the Nativis Voyager System in Patients With Recurrent Glioblastoma Multiforme (GBM). Download pdf flyer

Orbus Therapeutics (NCT02796261): 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. Download pdf flyer
Brain Metastases

Triphase MRZ-108 (NCT02330562): Dose-Expansion Cohort – Phase 2 Trial of Single Agent Marizomib in Progressive or Recurrent Grade IV Malignant Glioma. Download pdf flyer

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

Eli Lilly and Company (NCT02308020): 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. Download pdf flyer 

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

Kadmon (NCT02616393): 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. Download pdf flyer

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

Clinical Trial Team:
Najee Boucher, CRA  |  310-582-7460
Jaya M. Gill, RN, BSN  |  310-582-7437
Annie Heng, RN, BSN   |  310-582-7457
Tiffany Juarez, PhD
Marlon Garzo Saria, PhD, RN, AOCNS, FAAN