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Trial record 1 of 1 for:    NAT-101
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02296580
Recruitment Status : Recruiting
First Posted : November 20, 2014
Last Update Posted : January 30, 2019
Information provided by (Responsible Party):
Nativis, Inc.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
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)
Study Start Date : December 2014
Actual Primary Completion Date : January 21, 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT02296580

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Contact: Donna Morgan Murray, PhD 206-708-2288 ext 109

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United States, Alabama
University of Alabama at Birmingham (UAB) Completed
Birmingham, Alabama, United States, 35233
United States, Arizona
Center for Neurosciences Active, not recruiting
Tucson, Arizona, United States, 85718
United States, California
cCARE - California Cancer Associates for Research & Excellence Active, not recruiting
Encinitas, California, United States, 92024
John Wayne Cancer Institute @ Providecne St. Johns Health Center Active, not recruiting
Santa Monica, California, United States, 90404
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   
Principal Investigator: Jeffrey Gross, MD         
United States, Florida
Boca Raton Regional Hospital Active, not recruiting
Boca Raton, Florida, United States, 33486
United States, Kansas
University of Kansas Medical Center (KUMC) Recruiting
Kansas City, Kansas, United States, 66205
Contact: Sasha Moores    913-588-5520   
Principal Investigator: Michael Salacz, MD         
United States, Oregon
Providence Brain & Spine Institute Active, not recruiting
Portland, Oregon, United States, 97225
United States, Texas
Cancer Care Collaborative Recruiting
Austin, Texas, United States, 78705
Contact: Heidi Herndon, RN    512-324-7000 ext 77713   
Principal Investigator: Brian D Vaillant, MD         
Baylor Scott & White Health Recruiting
Temple, Texas, United States, 76508
Contact: Dedra Preece, BS, CCRP    254-724-5939   
Contact: Gates Anderson    254.724.5889   
Principal Investigator: Ekokobe Fonkem, DO         
United States, Washington
Virginia Mason Hospital & Medical Center Completed
Seattle, Washington, United States, 98101
Swedish Medical Center Active, not recruiting
Seattle, Washington, United States, 98122
St Vincent's Hospital Melbourne Active, not recruiting
Melbourne, Australia
Sponsors and Collaborators
Nativis, Inc.
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Study Director: Donna Morgan Murray, PhD Nativis, Inc.

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Responsible Party: Nativis, Inc. Identifier: NCT02296580     History of Changes
Other Study ID Numbers: NAT-101
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

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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
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue