A Feasibility Study of the Nativis Voyager System in Patients With Recurrent Glioblastoma Multiforme (GBM)

This feasibility study will assess the effects of the Nativis Voyager therapy in patients
with recurrent GBM who have either failed standard of care or are intolerant to therapy. The
study will enroll and treat up to 64 subjects of which 32 will be treated with the Voyager
therapy alone (monotherapy) and 32 will be treated with Voyager plus concurrent
chemotherapy. Safety and clinical utility will be evaluated.

Eligibility Criteria

Inclusion Criteria:

- Subject has histologically confirmed diagnosis of GBM.

- Subject has failed or intolerant to radiotherapy.

- Subjects has failed or intolerant to temozolomide therapy.

- Subject has at least one measureable lesion on MRI or CT.

- Subject is at least 18 years of age.

- Subject has a KPS ≥ 60.

- Subject has adequate organ and marrow function.

Exclusion Criteria:

- 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 has a clinically significant electrolyte abnormality.

- Subject has an active implantable or other electromagnetic device.

- Subject has a metal implant, including a stent, 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.

Principal Investigator

Michael Salacz

Study Contact

Christopher Baierl, cbaierl@kumc.edu, 913-588-3058

Estimated Completion Date

Thursday, June 1, 2017

ClinicalTrials.gov #

NCT02296580
07/13/2016