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

This feasibility study will assess the effects of the Nativis Voyager therapy in patients with first or second recurrence of GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to 32 subjects with Voyager plus lomustine with or without bevacizumab. Safety and clinical utility will be evaluated.

Study Overview

• Status: Completed
• Conditions: Glioblastoma Multiforme
• Intervention / Treatment: Device: Nativis Voyager RFE Therapy

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia
    • St Vincent's Hospital Melbourne
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham (UAB)
  • Arizona
    • Tucson, Arizona, United States, 85718
      • Center for Neurosciences
  • California
    • Encinitas, California, United States, 92024
      • cCARE - California Cancer Associates for Research & Excellence
    • Santa Monica, California, United States, 90404
      • John Wayne Cancer Institute @ Providecne St. Johns Health Center
  • Connecticut
    • Fairfield, Connecticut, United States, 06824
      • Associated Neurologists of Southern CT, P.C.
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Boca Raton Regional Hospital
  • Kansas
    • Kansas City, Kansas, United States, 66205
      • University of Kansas Medical Center (KUMC)
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Brain & Spine Institute
  • Texas
    • Austin, Texas, United States, 78705
      • Cancer Care Collaborative
    • Temple, Texas, United States, 76508
      • Baylor Scott & White Health
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center
    • Seattle, Washington, United States, 98101
      • Virginia Mason Hospital & Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject has histologically confirmed diagnosis of GBM.
• Subject has failed or intolerant to radiotherapy.
• Subjects has failed or intolerant to temozolomide therapy.
• Subject has progressive disease with at least one measureable lesion on MRI.
• Subject is at least 18 years of age.
• Subject has a KPS ≥ 60.
• Subject has adequate organ and marrow function.

Exclusion Criteria:

• Subject has received bevacizumab (Avastin).
• Subjecting has any condition, including compromised pulmonary function, that would preclude the use of lomustine.
• Subject is currently being treated with other investigational agents.
• Subject has received other investigational therapy within the last 28 days.
• Subject has received surgery within the last four weeks.
• Subject is within 12 weeks of completion of radiation.
• Subject has an active implantable or other electromagnetic device.
• Subject has a metal implant, including a programmable shunt, in the head or neck that is incompatible with MRI.
• Subject is known to be HIV positive.
• Subject is pregnant, nursing or intends to become pregnant during the course of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nativis Voyager RFE Therapy; Subjects will be treated with Nativis Voyager therapy until tumor progression.	Device: Nativis Voyager RFE Therapy; Nativis Voyager Radiofrequency Energy Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of any adverse events associated with the investigational therapy.	Safety Assessment as assessed by adverse events	Through one month following investigational treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Utility: PFS	Progression Free Survival as assessed by RANO	Six months
Clinical Utility: OS	Overall Survival	18 months

Collaborators and Investigators

• Sponsor: Nativis, Inc.
• Investigators: Study Director: Donna Morgan Murray, PhD, Nativis, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: November 18, 2014
• First Submitted That Met QC Criteria: November 19, 2014
• First Posted (Estimate): November 20, 2014

Study Record Updates

• Last Update Posted (Actual): February 2, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: NAT-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes