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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Nativis, Inc.
Sponsor:
Information provided by (Responsible Party):
Nativis, Inc.
ClinicalTrials.gov Identifier:
NCT02507102
First received: July 22, 2015
Last updated: September 20, 2016
Last verified: September 2016
  Purpose
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 Intervention
Glioblastoma Multiforme
Device: Voyager

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility Study of the Nativis Voyager™ System in Patients With Recurrent Glioblastoma Multiforme (GBM) in Australia

Resource links provided by NLM:


Further study details as provided by Nativis, Inc.:

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


Secondary Outcome Measures:
  • Overall survival at six months compared with historical response [ Time Frame: 6 months ]
  • Progression free survival [ Time Frame: 6 months ]

Estimated Enrollment: 11
Study Start Date: July 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational Voyager Therapy
Investigational treatment with Voyager Therapy
Device: Voyager
Non-invasive RFE therapy

  Eligibility

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02507102

Contacts
Contact: Char Bame, BSN MBA 206-775-5436 cbame@nativis.com

Locations
Australia, Victoria
St. Vincent's Hospital Melbourne Recruiting
Melbourne, Victoria, Australia, 3065
Contact: Emma Priest    61 3 9231 3551    emma.priest@svha.org.au   
Principal Investigator: Michael Murphy, MD         
Sponsors and Collaborators
Nativis, Inc.
  More Information

Responsible Party: Nativis, Inc.
ClinicalTrials.gov Identifier: NCT02507102     History of Changes
Other Study ID Numbers: NAT-105
Study First Received: July 22, 2015
Last Updated: September 20, 2016

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

ClinicalTrials.gov processed this record on May 25, 2017