Back to resultsA Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM) in Australia
Primary Purpose
Glioblastoma Multiforme
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Voyager
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 or CT.
- Subject is at least 18 years of age.
- Subject has a KPS ≥ 60.
- Subject has adequate organ and marrow function.
- Subject has provided signed informed consent.
Exclusion Criteria:
- Subject has life expectancy less than eight weeks
- Subject has received other investigational therapy within the last 28 days.
- Subject has received surgery within the last two weeks or not fully from prior surgery.
- Subject has a clinically significant electrolyte abnormality.
- Subject has an active implantable (e.g., neurostimulator, pacemaker) or other electromagnetic device.
- Subject has a metal implant, including a stent, 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 study period.
- Subject is participating in other investigational research.
- Subject has any condition that at the discretion of the investigator would preclude participation in the study.
- Subject is unable or unwilling to comply with the protocol-required follow-up schedule.
Sites / Locations
- St. Vincent's Hospital Melbourne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Investigational Voyager Therapy
Arm Description
Investigational treatment with Voyager Therapy
Outcomes
Primary Outcome Measures
Incidence and evaluation of any serious adverse events associated with the Nativis Voyager System
Tumor Response
Tumor imaging response (RANO) at two months of therapy.
Secondary Outcome Measures
Overall survival at six months compared with historical response
Progression free survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02507102
Brief Title
A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM) in Australia
Official Title
A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM) in Australia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
March 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nativis, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This feasibility study will assess the effects of the Nativis Voyager therapy in patients with recurrent GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to eleven subjects over six months. 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
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigational Voyager Therapy
Arm Type
Experimental
Arm Description
Investigational treatment with Voyager Therapy
Intervention Type
Device
Intervention Name(s)
Voyager
Intervention Description
Non-invasive RFE therapy
Primary Outcome Measure Information:
Title
Incidence and evaluation of any serious adverse events associated with the Nativis Voyager System
Time Frame
6 months
Title
Tumor Response
Description
Tumor imaging response (RANO) at two months of therapy.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Overall survival at six months compared with historical response
Time Frame
6 months
Title
Progression free survival
Time Frame
6 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 or CT.
Subject is at least 18 years of age.
Subject has a KPS ≥ 60.
Subject has adequate organ and marrow function.
Subject has provided signed informed consent.
Exclusion Criteria:
Subject has life expectancy less than eight weeks
Subject has received other investigational therapy within the last 28 days.
Subject has received surgery within the last two weeks or not fully from prior surgery.
Subject has a clinically significant electrolyte abnormality.
Subject has an active implantable (e.g., neurostimulator, pacemaker) or other electromagnetic device.
Subject has a metal implant, including a stent, 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 study period.
Subject is participating in other investigational research.
Subject has any condition that at the discretion of the investigator would preclude participation in the study.
Subject is unable or unwilling to comply with the protocol-required follow-up schedule.
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
St. Vincent's Hospital Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
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) in Australia
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