Status:
COMPLETED
A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)
Lead Sponsor:
Nativis, Inc.
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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. T...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT02296580
Start Date
February 1 2014
End Date
September 30 2021
Last Update
February 2 2023
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States, 35233
2
Center for Neurosciences
Tucson, Arizona, United States, 85718
3
cCARE - California Cancer Associates for Research & Excellence
Encinitas, California, United States, 92024
4
John Wayne Cancer Institute @ Providecne St. Johns Health Center
Santa Monica, California, United States, 90404