Clinical Trials Round Up: January 2019

Pacific Neuroscience Institute launches two new clinical trials this month.

New Studies

Cala Health (PDF): A Durability Study of the CALA TWO Device to Aid in the Transient Relief of Essential Tremor (NCT03597100)

The purpose of this study is to evaluate symptomatic hand tremor relief in the treated hand following stimulation with the Cala TWO device in adults with essential tremor over a 3-month duration

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)

The purpose of this study is to determine the efficacy of Optune (TTF) therapy with Bevacizumab as assessed by Progression Free Survival at 6 months (PFS-6) in patients with recurrent or progressive meningioma

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)

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

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)

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)

 

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) 

 

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 Neuro-Oncology 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:

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