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

This study is currently recruiting participants.
Verified November 2017 by Nativis, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02296580
First Posted: November 20, 2014
Last Update Posted: November 14, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Nativis, Inc.
  Purpose
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. Safety and clinical utility will be evaluated.

Condition Intervention
Glioblastoma Multiforme Device: Nativis Voyager RFE Therapy

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Nativis, Inc.:

Primary Outcome Measures:
  • 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:
  • Clinical Utility: PFS [ Time Frame: Six months ]
    Progression Free Survival as assessed by RANO

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


Estimated Enrollment: 32
Study Start Date: December 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
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 (CCNU). Safety and clinical utility will be evaluated.
  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


Contacts
Contact: Donna Morgan-Murray, PhD 206-708-2288 ext 109 dmorganmurray@nativis.com

Locations
United States, Alabama
University of Alabama at Birmingham (UAB) Recruiting
Birmingham, Alabama, United States, 35233
Contact: Thiru Pillay, RN BSN    205-934-1842    thiru@uab.edu   
Principal Investigator: Burt Nabors, MD         
United States, Arizona
Center for Neurosciences Recruiting
Tucson, Arizona, United States, 85718
Contact: Margie Pazzi, RN, MSN       mpazzi@neurotucson.com   
Principal Investigator: Michael Badruddoja, MD         
United States, California
cCARE - California Cancer Associates for Research & Excellence Active, not recruiting
Encinitas, California, United States, 92024
John Wayne Cancer Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Anand Moses    310-582-7097    mosesa@jwci.org   
Principal Investigator: Garni Barkhoudarian, MD         
United States, Connecticut
Associated Neurologists of Southern CT, P.C. Recruiting
Fairfield, Connecticut, United States, 06824
Contact: Tori Pascoe, CRC    203-333-1151 ext 4    tpascoe@anscneuro.com   
Principal Investigator: Nicholas Blondin, MD         
United States, Florida
Boca Raton Regional Hospital Recruiting
Boca Raton, Florida, United States, 33486
Contact: Viviana Boronat, MD    561-955-4800    vbornat@brrh.com   
Principal Investigator: Sajeel Chowdhary, MD         
United States, Kansas
University of Kansas Medical Center (KUMC) Active, not recruiting
Kansas City, Kansas, United States, 66303
United States, Texas
Seton Brain & Spine Institute Recruiting
Austin, Texas, United States, 78701
Contact: Heidi Herndon, RN    512-324-7000 ext 77713    hherndon@seton.org   
Principal Investigator: Brian D Vaillant, MD         
Baylor Scott & White Health Active, not recruiting
Temple, Texas, United States, 76508
United States, Washington
Virginia Mason Hospital & Medical Center Active, not recruiting
Seattle, Washington, United States, 98101
Swedish Medical Center Active, not recruiting
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Nativis, Inc.
  More Information

Responsible Party: Nativis, Inc.
ClinicalTrials.gov Identifier: NCT02296580     History of Changes
Other Study ID Numbers: NAT-101
First Submitted: November 18, 2014
First Posted: November 20, 2014
Last Update Posted: November 14, 2017
Last Verified: November 2017

Additional relevant 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