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

Study Overview
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Brief Summary
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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.

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

Conditions
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Glioblastoma Multiforme

Intervention / Treatment
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* Device: Voyager


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Voyager Therapy<br>Investigational treatment with Voyager Therapy | Device: Voyager<br>* Non-invasive RFE therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and evaluation of any serious adverse events associated with the Nativis Voyager System |  | 6 months | 
| Tumor Response | Tumor imaging response (RANO) at two months of therapy. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival at six months compared with historical response |  | 6 months | 
| Progression free survival |  | 6 months |