Back to resultsNativis Voyager for Newly Diagnosed GBM (NAT109)
Primary Purpose
Glioblastoma Multiforme
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nativis Voyager
Sponsored by
About this trial
This is an interventional device feasibility trial for Glioblastoma Multiforme
Eligibility Criteria
Inclusion Criteria:
- There is pathological evidence of GBM using World Health Organization (WHO) classification.
- Subject received maximal debulking surgery. Patients may enroll in the study if received Gliadel wafers before entering the trial. Any additional treatments received prior to enrollment will be considered an exclusion.
- Subject must have at least one measurable lesion per RANO.
- Subject is at least 18 years of age.
- Subject has a Karnofsky Performance Scale (KPS) ≥ 60.
- Subject has life expectancy > 3 months.
- Subject has adequate organ and marrow function; see note 1.
- Subject able to start treatment at least 28 days from tumor resection surgery.
- Subject has provided signed informed consent.
Exclusion Criteria:
- Subject has progressive disease per RANO. If pseudoprogression is suspected, additional imaging studies must be performed to rule out true progression.
- Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
- Subject is currently being treated with Optune.
- Subject is currently being treated with other investigational agents.
- Subject has not sufficiently recovered from prior surgery in the opinion of the investigator.
- Subject has significant co-morbidities at baseline which would prevent radiotherapy and/or temozolomide treatment.
- Subject has history of hypersensitivity reaction to temozolomide or a history of hypersensitivity to dacarbazine (DTIC).
- Subject has a clinically significant electrolyte abnormality.
- Subject has an active implantable (e.g., neurostimulator, pacemaker) or other electromagnetic device that is incompatible with MRI. Subjects with programmable shunt are excluded from the study.
- 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 potentially confounding 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
- Center for Neurosciences
- California Cancer Care Associates
- John Wayne Cancer Institute @ Providence St Johns Health Center
- Associated Neurologists of Southern CT, PC
- Boca Raton Regional Hospital
- Cancer Care Collaborative
- Baylor Scott and White Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nativis Voyager
Arm Description
Nativis Voyager combined with SOC Radiotherapy and temozolomide
Outcomes
Primary Outcome Measures
Treatment-related Adverse Events (Safety)
Safety as measured by number of investigational treatment-related adverse events as assessed by CTCAE v4.0.
Secondary Outcome Measures
Clinical Utility PFS
Progression Free Survival
Clinical Utility OS
Overall Survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03276286
Brief Title
Nativis Voyager for Newly Diagnosed GBM
Acronym
NAT109
Official Title
A Feasibility Study of the Nativis Voyager® System in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 10, 2017 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This feasibility study will assess the effects of the Nativis Voyager therapy in patients newly diagnosed with GBM. The study will enroll and treat up to 32 subjects and will be combined with standard of care radiotherapy and temozolomide.
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
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Nativis Voyager combined with standard radiotherapy and temozolomide
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nativis Voyager
Arm Type
Experimental
Arm Description
Nativis Voyager combined with SOC Radiotherapy and temozolomide
Intervention Type
Device
Intervention Name(s)
Nativis Voyager
Intervention Description
Nativis Voyager treatment combined with standard of care radiotherapy and temozolomide
Primary Outcome Measure Information:
Title
Treatment-related Adverse Events (Safety)
Description
Safety as measured by number of investigational treatment-related adverse events as assessed by CTCAE v4.0.
Time Frame
Through study completion, average of 1 year
Secondary Outcome Measure Information:
Title
Clinical Utility PFS
Description
Progression Free Survival
Time Frame
6 months
Title
Clinical Utility OS
Description
Overall Survival
Time Frame
Through patient completion, expected average 8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
There is pathological evidence of GBM using World Health Organization (WHO) classification.
Subject received maximal debulking surgery. Patients may enroll in the study if received Gliadel wafers before entering the trial. Any additional treatments received prior to enrollment will be considered an exclusion.
Subject must have at least one measurable lesion per RANO.
Subject is at least 18 years of age.
Subject has a Karnofsky Performance Scale (KPS) ≥ 60.
Subject has life expectancy > 3 months.
Subject has adequate organ and marrow function; see note 1.
Subject able to start treatment at least 28 days from tumor resection surgery.
Subject has provided signed informed consent.
Exclusion Criteria:
Subject has progressive disease per RANO. If pseudoprogression is suspected, additional imaging studies must be performed to rule out true progression.
Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
Subject is currently being treated with Optune.
Subject is currently being treated with other investigational agents.
Subject has not sufficiently recovered from prior surgery in the opinion of the investigator.
Subject has significant co-morbidities at baseline which would prevent radiotherapy and/or temozolomide treatment.
Subject has history of hypersensitivity reaction to temozolomide or a history of hypersensitivity to dacarbazine (DTIC).
Subject has a clinically significant electrolyte abnormality.
Subject has an active implantable (e.g., neurostimulator, pacemaker) or other electromagnetic device that is incompatible with MRI. Subjects with programmable shunt are excluded from the study.
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 potentially confounding 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 Chair
Facility Information:
Facility Name
Center for Neurosciences
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Facility Name
California Cancer Care Associates
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
John Wayne Cancer Institute @ Providence St Johns Health Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Associated Neurologists of Southern CT, PC
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
Cancer Care Collaborative
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Baylor Scott and White Health
City
Temple
State/Province
Texas
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nativis Voyager for Newly Diagnosed GBM
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