Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02296580
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : February 2, 2023
Sponsor:
Information provided by (Responsible Party):
Nativis, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Device: Nativis Voyager RFE Therapy Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)
Actual Study Start Date : February 2014
Actual Primary Completion Date : September 30, 2021
Actual Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of any adverse events associated with the investigational therapy. [ Time Frame: Through one month following investigational treatment ]
    Safety Assessment as assessed by adverse events


Secondary Outcome Measures :
  1. Clinical Utility: PFS [ Time Frame: Six months ]
    Progression Free Survival as assessed by RANO

  2. Clinical Utility: OS [ Time Frame: 18 months ]
    Overall Survival


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02296580


Locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States, 35233
United States, Arizona
Center for Neurosciences
Tucson, Arizona, United States, 85718
United States, California
cCARE - California Cancer Associates for Research & Excellence
Encinitas, California, United States, 92024
John Wayne Cancer Institute @ Providecne St. Johns Health Center
Santa Monica, California, United States, 90404
United States, Connecticut
Associated Neurologists of Southern CT, P.C.
Fairfield, Connecticut, United States, 06824
United States, Florida
Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486
United States, Kansas
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, United States, 66205
United States, Oregon
Providence Brain & Spine Institute
Portland, Oregon, United States, 97225
United States, Texas
Cancer Care Collaborative
Austin, Texas, United States, 78705
Baylor Scott & White Health
Temple, Texas, United States, 76508
United States, Washington
Virginia Mason Hospital & Medical Center
Seattle, Washington, United States, 98101
Swedish Medical Center
Seattle, Washington, United States, 98122
Australia
St Vincent's Hospital Melbourne
Melbourne, Australia
Sponsors and Collaborators
Nativis, Inc.
Investigators
Layout table for investigator information
Study Director: Donna Morgan Murray, PhD Nativis, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Nativis, Inc.
ClinicalTrials.gov Identifier: NCT02296580    
Other Study ID Numbers: NAT-101
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: February 2, 2023
Last Verified: January 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue