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 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.

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Key information

Conditions

Glioblastoma Multiforme Astrocytoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Vincent's Hospital Melbourne, Melbourne, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nativis Voyager RFE Therapy

Device

Nativis Voyager Radiofrequency Energy Therapy

Primary outcomes

Number of any adverse events associated with the investigational therapy.

Time frame: Through one month following investigational treatment

Safety Assessment as assessed by adverse events

Secondary outcomes

Clinical Utility: PFS

Time frame: Six months

Progression Free Survival as assessed by RANO
Clinical Utility: OS

Time frame: 18 months

Overall Survival

Sponsors and collaborators

Lead sponsor

Nativis, Inc.

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2021
Study completion: 2021
First posted: Nov 20, 2014
Registry last updated: Feb 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed