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Completed

NCT Number: NCT02507102

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

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.

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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, Victoria, 3065, 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 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.

Treatment and study plan

Voyager

Device

Non-invasive RFE therapy

Primary outcomes

  1. Incidence and evaluation of any serious adverse events associated with the Nativis Voyager System

    Time frame: 6 months

  2. Tumor Response

    Time frame: 2 months

    Tumor imaging response (RANO) at two months of therapy.

Secondary outcomes

  1. Overall survival at six months compared with historical response

    Time frame: 6 months

  2. Progression free survival

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Nativis, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jul 23, 2015
Registry last updated
Mar 30, 2018

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.

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