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

Sponsor
Nativis, Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02296580
Collaborator
(none)
32
Enrollment
13
Locations
1
Arm
72
Anticipated Duration (Months)
2.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Nativis Voyager RFE Therapy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 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 :
Feb 1, 2014
Anticipated Primary Completion Date :
Jan 31, 2020
Anticipated Study Completion Date :
Jan 31, 2020

Arms and Interventions

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

Primary Outcome Measures

  1. Number of any adverse events associated with the investigational therapy. [Through one month following investigational treatment]

    Safety Assessment as assessed by adverse events

Secondary Outcome Measures

  1. Clinical Utility: PFS [Six months]

    Progression Free Survival as assessed by RANO

  2. Clinical Utility: OS [18 months]

    Overall Survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Nativis, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nativis, Inc.
ClinicalTrials.gov Identifier:
NCT02296580
Other Study ID Numbers:
  • NAT-101
First Posted:
Nov 20, 2014
Last Update Posted:
May 15, 2019
Last Verified:
May 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Glioblastoma

Study Results

No Results Posted as of May 15, 2019