A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)
NCT ID: NCT02296580
Last Updated: 2023-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2014-02-28
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nativis Voyager RFE Therapy
Subjects will be treated with Nativis Voyager therapy until tumor progression.
Nativis Voyager RFE Therapy
Nativis Voyager Radiofrequency Energy Therapy
Interventions
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Nativis Voyager RFE Therapy
Nativis Voyager Radiofrequency Energy Therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Nativis, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Donna Morgan Murray, PhD
Role: STUDY_DIRECTOR
Nativis, Inc.
Locations
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University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
Center for Neurosciences
Tucson, Arizona, United States
cCARE - California Cancer Associates for Research & Excellence
Encinitas, California, United States
John Wayne Cancer Institute @ Providecne St. Johns Health Center
Santa Monica, California, United States
Associated Neurologists of Southern CT, P.C.
Fairfield, Connecticut, United States
Boca Raton Regional Hospital
Boca Raton, Florida, United States
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, United States
Providence Brain & Spine Institute
Portland, Oregon, United States
Cancer Care Collaborative
Austin, Texas, United States
Baylor Scott & White Health
Temple, Texas, United States
Virginia Mason Hospital & Medical Center
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
St Vincent's Hospital Melbourne
Melbourne, , Australia
Countries
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References
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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.
Other Identifiers
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NAT-101
Identifier Type: -
Identifier Source: org_study_id
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