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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 September 2017 by Nativis, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02296580
First Posted: November 20, 2014
Last Update Posted: October 12, 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.
November 18, 2014
November 20, 2014
October 12, 2017
December 2014
June 2018   (Final data collection date for primary outcome measure)
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
  • Number of any adverse events associated with the investigational therapy. [ Time Frame: 6 months ]
  • Tumor Progression [ Time Frame: Two months ]
    Radiological response of the tumor will be assessed by MRI studies according to RANO
Complete list of historical versions of study NCT02296580 on ClinicalTrials.gov Archive Site
  • Clinical Utility: PFS [ Time Frame: Six months ]
    Progression Free Survival as assessed by RANO
  • Clinical Utility: OS [ Time Frame: 18 months ]
    Overall Survival
Overall survival and progression free survival [ Time Frame: six months ]
Not Provided
Not Provided
 
A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)
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. Safety and clinical utility will be evaluated.
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Glioblastoma Multiforme
Device: Nativis Voyager RFE Therapy
Nativis Voyager Radiofrequency Energy Therapy
Experimental: Nativis Voyager RFE Therapy
Subjects will be treated with Nativis Voyager therapy until tumor progression.
Intervention: Device: Nativis Voyager RFE Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
December 2018
June 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Donna Morgan-Murray, PhD 206-708-2288 ext 109 dmorganmurray@nativis.com
United States
 
 
NCT02296580
NAT-101
No
Not Provided
Not Provided
Nativis, Inc.
Nativis, Inc.
Not Provided
Not Provided
Nativis, Inc.
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP