A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02296580|
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : February 2, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Device: Nativis Voyager RFE Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)|
|Actual Study Start Date :||February 2014|
|Actual Primary Completion Date :||September 30, 2021|
|Actual Study Completion Date :||September 30, 2021|
Experimental: Nativis Voyager RFE Therapy
Subjects will be treated with Nativis Voyager therapy until tumor progression.
Device: Nativis Voyager RFE Therapy
Nativis Voyager Radiofrequency Energy Therapy
- Number of any adverse events associated with the investigational therapy. [ Time Frame: Through one month following investigational treatment ]Safety Assessment as assessed by adverse events
- Clinical Utility: PFS [ Time Frame: Six months ]Progression Free Survival as assessed by RANO
- Clinical Utility: OS [ Time Frame: 18 months ]Overall Survival
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02296580
|United States, Alabama|
|University of Alabama at Birmingham (UAB)|
|Birmingham, Alabama, United States, 35233|
|United States, Arizona|
|Center for Neurosciences|
|Tucson, Arizona, United States, 85718|
|United States, California|
|cCARE - California Cancer Associates for Research & Excellence|
|Encinitas, California, United States, 92024|
|John Wayne Cancer Institute @ Providecne St. Johns Health Center|
|Santa Monica, California, United States, 90404|
|United States, Connecticut|
|Associated Neurologists of Southern CT, P.C.|
|Fairfield, Connecticut, United States, 06824|
|United States, Florida|
|Boca Raton Regional Hospital|
|Boca Raton, Florida, United States, 33486|
|United States, Kansas|
|University of Kansas Medical Center (KUMC)|
|Kansas City, Kansas, United States, 66205|
|United States, Oregon|
|Providence Brain & Spine Institute|
|Portland, Oregon, United States, 97225|
|United States, Texas|
|Cancer Care Collaborative|
|Austin, Texas, United States, 78705|
|Baylor Scott & White Health|
|Temple, Texas, United States, 76508|
|United States, Washington|
|Virginia Mason Hospital & Medical Center|
|Seattle, Washington, United States, 98101|
|Swedish Medical Center|
|Seattle, Washington, United States, 98122|
|St Vincent's Hospital Melbourne|
|Study Director:||Donna Morgan Murray, PhD||Nativis, Inc.|
|Responsible Party:||Nativis, Inc.|
|Other Study ID Numbers:||
|First Posted:||November 20, 2014 Key Record Dates|
|Last Update Posted:||February 2, 2023|
|Last Verified:||January 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Device Product Not Approved or Cleared by U.S. FDA:||Yes|
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