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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nativis Voyager RFE Therapy | Experimental | Subjects will be treated with Nativis Voyager therapy until tumor progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nativis Voyager RFE Therapy | Device | Nativis Voyager Radiofrequency Energy Therapy |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Utility: PFS | Progression Free Survival as assessed by RANO | Six months |
| Clinical Utility: OS | Overall Survival | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donna Morgan Murray, PhD | Nativis, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham (UAB) | Birmingham | Alabama | 35233 | United States | ||
| Center for Neurosciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37462385 | Derived | Barkhoudarian G, Badruddoja M, Blondin N, Chowdhary S, Cobbs C, Duic JP, Flores JP, Fonkem E, McClay E, Nabors LB, Salacz M, Taylor L, Vaillant B, Gill J, Kesari S. An expanded safety/feasibility study of the EMulate Therapeutics Voyager System in patients with recurrent glioblastoma. CNS Oncol. 2023 Sep 1;12(3):CNS102. doi: 10.2217/cns-2022-0016. Epub 2023 Jul 18. |
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| Tucson |
| Arizona |
| 85718 |
| United States |
| cCARE - California Cancer Associates for Research & Excellence | Encinitas | California | 92024 | United States |
| John Wayne Cancer Institute @ Providecne St. Johns Health Center | Santa Monica | California | 90404 | United States |
| Associated Neurologists of Southern CT, P.C. | Fairfield | Connecticut | 06824 | United States |
| Boca Raton Regional Hospital | Boca Raton | Florida | 33486 | United States |
| University of Kansas Medical Center (KUMC) | Kansas City | Kansas | 66205 | United States |
| Providence Brain & Spine Institute | Portland | Oregon | 97225 | United States |
| Cancer Care Collaborative | Austin | Texas | 78705 | United States |
| Baylor Scott & White Health | Temple | Texas | 76508 | United States |
| Virginia Mason Hospital & Medical Center | Seattle | Washington | 98101 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| St Vincent's Hospital Melbourne | Melbourne | Australia |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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