Clinical Trials Round Up: February 2019

Pacific Neuroscience Institute is pleased to announce two new clinical trials this month.

New Studies

Bioness OAB (PDF):Pivotal Randomized Clinical Trial of Peripheral Nerve Stimulation with StimRouter Neuromodulation System in Overactive Bladder (NCT02873312)

The purpose of this study is to assess the efficacy of the StimRouter stimulation therapy in improving OAB symptoms of urgency and frequency as measured by Patient Voiding Diary when targeting the posterior tibial nerve. 

Stemedica (PDF):A Phase IIA, Multi-Center, Randomized, Single-Blind, Placebo-Controlled, Crossover Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogenic Human Mesenchymal Stem Cells to Subjects with Mild to Moderate Dementia due to Alzheimer’s Disease (NCT02833792)

The purpose of this study is to assess the safety and tolerability of ischemia-tolerant allogeneic human mesenchymal stem cells (hMSCs) versus placebo administered intravenously 

Actively Recruiting Studies

Brain Cancer (Primary)

Aadi Bioscience (PDF):A Phase 2, Open-label Study of ABI-009 (nab-Rapamycin) in Bevacizumab-naïve Patients with Recurrent High-grade Glioma and in Patients with Newly Diagnosed Glioblastoma (NCT03463265)

Aivita Biomedical (PDF):Phase II trial of AV-GBM-1 (autologous dendritic cells loaded with autologous tumor associated antigens) as an adjunctive therapy following primary surgery plus concurrent chemoradiation in patients with Newly-Diagnosed Glioblastoma Multiforme (GBM) (NCT03276268) 

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)

Boston Biomedical (PDF): A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma (GBM)Following Initial Therapy (NCT03149003)

Caris (PDF): Caris Molecular Intelligence Repository

Diffusion (PDF): An Open-label, Randomized, Controlled, Phase 3 Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) with Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects (NCT03393000)

Medicenna Therapeutics, Inc. (PDF):An Open-Label Non-Randomized, Multi-Center Phase-2 Study of Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma (NCT02858895)

Northwestern University (PDF):A Phase 2, single arm, multi-center, open label trial Combining Optune with concurrent Bevacizumab in the setting of Recurrent or Progressive Meningioma (NCT02847559) 

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)

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)

Pacific Neuroscience Institute/Saint John’s Cancer Institute (PDF): Neurological Outcomes in Health and Disease

Pacific Neuroscience Institute/Saint John’s Cancer Institute (PDF): A Longitudinal Assessment of Tumor Evolution in Patients with Brain Cancer (NCT03425292)

  

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)

 

Solid Tumors

Sanofi Aventis (PDF): A Phase 1/2 Open-label, Multi-center, Safety, Preliminary Efficacy and Pharmacokinetic (PK) Study of Isatuximab in Combination with Atezolizumab or Isatuximab Alone in Patients with Advanced Malignancies (NCT03463265)

Spectrum Pharmaceuticals (PDF):An Open-label, Nonrandomized, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Belinostat in Patients with Relapsed/Refractory Solid Tumors or Hematological Malignancies Who Have Wild-Type, Heterozygous, and Homozygous UGT1A1*28 Genotypes (NCT03276268) 

Prevlar (PDF): A Phase 2a Randomized, Parallel Group, Open-Label, Multicenter Study to Assess the Safety and Efficacy of Different Schedules of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Concomitant Chemoradiation for the Treatment of Locally Advanced Squamous Cell Carcinomas of the Oral Cavity or Oropharynx. (NCT03515538)

 

Neurology

Microtransponder (PDF): A Pivotal Randomized Study Assessing Vagus Nerve Stimulation (VNS) During Rehabilitation for Improved Upper Limb Motor Function After Stroke (VNS-REHAB) (NCT03131960)

Pacific Neuroscience Institute/Saint John’s Cancer Institute (PDF): Neurological Outcomes in Health and Disease

 

Quality and Outcomes Research

CancerLife2 (PDF): CancerLife: Patient-Driven Solution in Cancer Care (NCT03371147) 

Family Caregivers (PDF): An Exploratory Study of Caregiver Burden Among Family Caregivers of Cancer Patients (NCT03069105)

Pacific Neuroscience Institute/Saint John’s Cancer Institute (PDF): An Observational Study of Memantine XR (extended release) and Pregabalin Combination Therapy in Chemotherapy-Induced Peripheral Neuropathy (CIPN) (NCT03709888)

For more information, please explore the hyperlinks or contact the Neurosciences Clinical Trials Team at:
e-mail: neuro.oncology@jwci.org  |  phone: 310-829-8265
Current Clinical Trials 

Investigators:

Achal S. Achrol, MD
Garni Barkhoudarian, MD
Jose Carrillo, MD
Daniel Kelly, MD
Santosh Kesari MD, PhD, FANA, FAAN
Steven O’Day, MD
Melita Petrossian, MD
Marlon Garzo Saria, PhD, RN, FAAN

Clinical Trials Team:

Richard Bailey, CRA, BaileyR@jwci.org, phone 310-582-8808
Jaya M. Gill, RN., BSN, jaya.gill@providence.org, 310-582-7437
Annie Heng, RN, BSN, HengA@jwci.org, 310-582-7457
Tiffany Juarez, PhD, tiffany.juarez@jwci.org, 310-449-5225
Anand Moses, CRA, MosesA@jwci.org, 310-582-7097
Hanh Nguyen, CRA, NguyenThuyH@jwci.org, 310-582-7434
Michelle Phillips, Michelle.Phillips@providence.org, 310-582-7486  

Jaya Mini Gill, RN, BSN is involved in all aspects of clinical trial study design and processes in the Department of Translational Neurosciences and Neurotherapeutics at the Saint John’s Cancer Institute. An experienced nurse, she is responsible for accurate protocol implementation along with the treatment, care, management, and follow-up of patients.