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

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ClinicalTrials.gov Identifier: NCT02507102
Recruitment Status : Completed
First Posted : July 23, 2015
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Nativis, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Device: Voyager Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM) in Australia
Actual Study Start Date : August 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : March 26, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  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 Outcome Measures :
  1. Overall survival at six months compared with historical response [ Time Frame: 6 months ]
  2. Progression free survival [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507102


Locations
Australia, Victoria
St. Vincent's Hospital Melbourne
Melbourne, Victoria, Australia, 3065
Sponsors and Collaborators
Nativis, Inc.
Investigators
Study Director: Donna Morgan Murray, PhD Nativis, Inc.

Responsible Party: Nativis, Inc.
ClinicalTrials.gov Identifier: NCT02507102     History of Changes
Other Study ID Numbers: NAT-105
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue