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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nativis Voyager | Experimental | Nativis Voyager combined with SOC Radiotherapy and temozolomide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nativis Voyager | Device | Nativis Voyager treatment combined with standard of care radiotherapy and temozolomide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related Adverse Events (Safety) | Safety as measured by number of investigational treatment-related adverse events as assessed by CTCAE v4.0. | Through study completion, average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Utility PFS | Progression Free Survival | 6 months |
| Clinical Utility OS | Overall Survival | Through patient completion, expected average 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donna Morgan Murray, PhD | Nativis, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Neurosciences | Tucson | Arizona | 85718 | United States | ||
| California Cancer Care Associates |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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Nativis Voyager combined with standard radiotherapy and temozolomide
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| Encinitas |
| California |
| 92024 |
| United States |
| John Wayne Cancer Institute @ Providence St Johns Health Center | Santa Monica | California | 90404 | United States |
| Associated Neurologists of Southern CT, PC | Fairfield | Connecticut | 06824 | United States |
| Boca Raton Regional Hospital | Boca Raton | Florida | 33486 | United States |
| Cancer Care Collaborative | Austin | Texas | 78705 | United States |
| Baylor Scott and White Health | Temple | Texas | 98101 | United States |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |