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

Nativis

Status

Completed

Conditions

Glioblastoma Multiforme

Treatments

Device: Voyager

Study type

Interventional

Funder types

Industry

Identifiers

NCT02507102

NAT-105

Details and patient eligibility

About

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 eleven subjects over six months. Safety and clinical utility will be evaluated.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 or CT.
Subject is at least 18 years of age.
Subject has a KPS ≥ 60.
Subject has adequate organ and marrow function.
Subject has provided signed informed consent.

Exclusion criteria

Subject has life expectancy less than eight weeks
Subject has received other investigational therapy within the last 28 days.
Subject has received surgery within the last two weeks or not fully from prior surgery.
Subject has a clinically significant electrolyte abnormality.
Subject has an active implantable (e.g., neurostimulator, pacemaker) 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 study period.
Subject is participating in other investigational research.
Subject has any condition that at the discretion of the investigator would preclude participation in the study.
Subject is unable or unwilling to comply with the protocol-required follow-up schedule.