A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)
Completed · Not applicable
Conditions studied: Glioblastoma Multiforme
In brief
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.
Key facts
- Study ID
- NCT02296580
- Run by
- Nativis, Inc.
- People needed
- 37
- Starts
- 2014-02-01
- Expected to finish
- 2021-09-30
- Last updated by the study team
- 2023-02-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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