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

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 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

• 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.