Back to resultsA Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)
Primary Purpose
Glioblastoma Multiforme
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Nativis Voyager RFE Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma Multiforme
Eligibility 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.
Sites / Locations
- University of Alabama at Birmingham (UAB)
- Center for Neurosciences
- cCARE - California Cancer Associates for Research & Excellence
- John Wayne Cancer Institute @ Providecne St. Johns Health Center
- Associated Neurologists of Southern CT, P.C.
- Boca Raton Regional Hospital
- University of Kansas Medical Center (KUMC)
- Providence Brain & Spine Institute
- Cancer Care Collaborative
- Baylor Scott & White Health
- Virginia Mason Hospital & Medical Center
- Swedish Medical Center
- St Vincent's Hospital Melbourne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nativis Voyager RFE Therapy
Arm Description
Subjects will be treated with Nativis Voyager therapy until tumor progression.
Outcomes
Primary Outcome Measures
Number of any adverse events associated with the investigational therapy.
Safety Assessment as assessed by adverse events
Secondary Outcome Measures
Clinical Utility: PFS
Progression Free Survival as assessed by RANO
Clinical Utility: OS
Overall Survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02296580
Brief Title
A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)
Official Title
A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nativis, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nativis Voyager RFE Therapy
Arm Type
Experimental
Arm Description
Subjects will be treated with Nativis Voyager therapy until tumor progression.
Intervention Type
Device
Intervention Name(s)
Nativis Voyager RFE Therapy
Intervention Description
Nativis Voyager Radiofrequency Energy Therapy
Primary Outcome Measure Information:
Title
Number of any adverse events associated with the investigational therapy.
Description
Safety Assessment as assessed by adverse events
Time Frame
Through one month following investigational treatment
Secondary Outcome Measure Information:
Title
Clinical Utility: PFS
Description
Progression Free Survival as assessed by RANO
Time Frame
Six months
Title
Clinical Utility: OS
Description
Overall Survival
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna Morgan Murray, PhD
Organizational Affiliation
Nativis, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham (UAB)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Center for Neurosciences
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Facility Name
cCARE - California Cancer Associates for Research & Excellence
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
John Wayne Cancer Institute @ Providecne St. Johns Health Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Associated Neurologists of Southern CT, P.C.
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Boca Raton Regional Hospital
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
University of Kansas Medical Center (KUMC)
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Providence Brain & Spine Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Cancer Care Collaborative
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Baylor Scott & White Health
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Virginia Mason Hospital & Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
St Vincent's Hospital Melbourne
City
Melbourne
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)
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