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

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 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.

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

Conditions
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Glioblastoma Multiforme

Intervention / Treatment
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* Device: Nativis Voyager RFE Therapy


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. 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.

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: Nativis Voyager RFE Therapy<br>Subjects will be treated with Nativis Voyager therapy until tumor progression. | Device: Nativis Voyager RFE Therapy<br>* Nativis Voyager Radiofrequency Energy Therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of any adverse events associated with the investigational therapy. | Safety Assessment as assessed by adverse events | Through one month following investigational treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Utility: PFS | Progression Free Survival as assessed by RANO | Six months | 
| Clinical Utility: OS | Overall Survival | 18 months |