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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nativis, Inc.
ClinicalTrials.gov Identifier:
NCT02296580
First received: November 18, 2014
Last updated: August 23, 2017
Last verified: August 2017
  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 64 subjects of which 32 will be treated with the Voyager therapy alone (monotherapy) and 32 will be treated with Voyager plus concurrent chemotherapy. Safety and clinical utility will be evaluated.

Condition Intervention
Glioblastoma Multiforme Device: Nativis Voyager RFE Therapy

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Nativis, Inc.:

Primary Outcome Measures:
  • Number of any adverse events associated with the investigational therapy. [ Time Frame: 6 months ]
  • Progression-free Survival (PFS) [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Tumor Progression [ Time Frame: Two months ]
    Radiological response of the tumor will be assessed by MRI studies according to RANO

  • Overall Survival [ Time Frame: 6 months ]

Enrollment: 64
Study Start Date: December 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nativis Voyager RFE Therapy
Subjects will be treated with Nativis Voyager therapy for up to six months.
Device: Nativis Voyager RFE Therapy
Nativis Voyager Radiofrequency Energy Therapy

Detailed Description:
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 64 subjects of which 32 will be treated with the Voyager therapy alone (monotherapy) and 32 will be treated with Voyager plus concurrent chemotherapy. Safety and clinical utility will be evaluated.
  Eligibility

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

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 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.

Exclusion Criteria:

  • 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 has a clinically significant electrolyte abnormality.
  • Subject has an active implantable 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 course of the study.
  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: NCT02296580

Locations
United States, Alabama
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States, 35233
United States, Arizona
Center for Neurosciences
Tucson, Arizona, United States, 85718
United States, California
cCARE - California Cancer Associates for Research & Excellence
Encinitas, California, United States, 92024
John Wayne Cancer Institute
Santa Monica, California, United States, 90404
United States, Connecticut
Associated Neurologists of Southern CT, P.C.
Fairfield, Connecticut, United States, 06824
United States, Florida
Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486
United States, Kansas
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, United States, 66303
United States, Texas
Seton Brain & Spine Institute
Austin, Texas, United States, 78701
Baylor Scott & White Health
Temple, Texas, United States, 76508
United States, Washington
Virginia Mason Hospital & Medical Center
Seattle, Washington, United States, 98101
Swedish Medical Center
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Nativis, Inc.
  More Information

Responsible Party: Nativis, Inc.
ClinicalTrials.gov Identifier: NCT02296580     History of Changes
Other Study ID Numbers: NAT-101
Study First Received: November 18, 2014
Last Updated: August 23, 2017

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 September 19, 2017