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

March 28, 2018 updated by: Nativis, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3065
        • St. Vincent's Hospital Melbourne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject has histologically confirmed diagnosis of GBM.
  2. Subject has failed or intolerant to radiotherapy.
  3. Subjects has failed or intolerant to temozolomide therapy.
  4. Subject has progressive disease with at least one measureable lesion on MRI or CT.
  5. Subject is at least 18 years of age.
  6. Subject has a KPS ≥ 60.
  7. Subject has adequate organ and marrow function.
  8. Subject has provided signed informed consent.

Exclusion Criteria:

  1. Subject has life expectancy less than eight weeks
  2. Subject has received other investigational therapy within the last 28 days.
  3. Subject has received surgery within the last two weeks or not fully from prior surgery.
  4. Subject has a clinically significant electrolyte abnormality.
  5. Subject has an active implantable (e.g., neurostimulator, pacemaker) or other electromagnetic device.
  6. Subject has a metal implant, including a stent, in the head or neck that is incompatible with MRI.
  7. Subject is known to be HIV positive.
  8. Subject is pregnant, nursing or intends to become pregnant during the study period.
  9. Subject is participating in other investigational research.
  10. Subject has any condition that at the discretion of the investigator would preclude participation in the study.
  11. Subject is unable or unwilling to comply with the protocol-required follow-up schedule.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational Voyager Therapy
Investigational treatment with Voyager Therapy
Device: Voyager
Non-invasive RFE therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and evaluation of any serious adverse events associated with the Nativis Voyager System
Time Frame: 6 months
6 months
Tumor Response
Time Frame: 2 months
Tumor imaging response (RANO) at two months of therapy.
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: 6 months
6 months
Overall survival at six months compared with historical response
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nativis, Inc.

Investigators

  • Study Director: Donna Morgan Murray, PhD, Nativis, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

March 26, 2018

Study Registration Dates

First Submitted

July 22, 2015

First Submitted That Met QC Criteria

July 22, 2015

First Posted (Estimate)

July 23, 2015

Study Record Updates

Last Update Posted (Actual)

March 30, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAT-105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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