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Nativis Voyager for Newly Diagnosed GBM (NAT109)

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ClinicalTrials.gov Identifier: NCT03276286
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Nativis, Inc.

Study Description
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Brief Summary:
This feasibility study will assess the effects of the Nativis Voyager therapy in patients newly diagnosed with GBM. The study will enroll and treat up to 32 subjects and will be combined with standard of care radiotherapy and temozolomide.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Nativis Voyager combined with standard radiotherapy and temozolomide
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A Feasibility Study of the Nativis Voyager® System in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)
Actual Study Start Date : November 10, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Nativis Voyager
Nativis Voyager combined with SOC Radiotherapy and temozolomide
 Device: Nativis Voyager
Nativis Voyager treatment combined with standard of care radiotherapy and temozolomide


Outcome Measures
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Primary Outcome Measures :
  1. Treatment-related Adverse Events (Safety) [ Time Frame: Through study completion, average of 1 year ]
    Safety as measured by number of investigational treatment-related adverse events as assessed by CTCAE v4.0.


Secondary Outcome Measures :
  1. Clinical Utility PFS [ Time Frame: 6 months ]
    Progression Free Survival

  2. Clinical Utility OS [ Time Frame: Through patient completion, expected average 8 months ]
    Overall Survival


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

Inclusion Criteria:

  • There is pathological evidence of GBM using World Health Organization (WHO) classification.
  • Subject received maximal debulking surgery. Patients may enroll in the study if received Gliadel wafers before entering the trial. Any additional treatments received prior to enrollment will be considered an exclusion.
  • Subject must have at least one measurable lesion per RANO.
  • Subject is at least 18 years of age.
  • Subject has a Karnofsky Performance Scale (KPS) ≥ 60.
  • Subject has life expectancy > 3 months.
  • Subject has adequate organ and marrow function; see note 1.
  • Subject able to start treatment at least 28 days from tumor resection surgery.
  • Subject has provided signed informed consent.

Exclusion Criteria:

  • Subject has progressive disease per RANO. If pseudoprogression is suspected, additional imaging studies must be performed to rule out true progression.
  • Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
  • Subject is currently being treated with Optune.
  • Subject is currently being treated with other investigational agents.
  • Subject has not sufficiently recovered from prior surgery in the opinion of the investigator.
  • Subject has significant co-morbidities at baseline which would prevent radiotherapy and/or temozolomide treatment.
  • Subject has history of hypersensitivity reaction to temozolomide or a history of hypersensitivity to dacarbazine (DTIC).
  • Subject has a clinically significant electrolyte abnormality.
  • Subject has an active implantable (e.g., neurostimulator, pacemaker) or other electromagnetic device that is incompatible with MRI. Subjects with programmable shunt are excluded from the study.
  • 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 potentially confounding 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.
Contacts and Locations
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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): NCT03276286


Contacts
Contact: Donna Morgan Murray, PhD 206-708-2288 dmorganmurray@nativis.com

Locations
United States, Alabama
University of Alabama at Birmingham (UAB) Not yet recruiting
Birmingham, Alabama, United States, 35233
Contact: Thiru Pillay, RN BSN    205-934-1842    tpillay@uab.edu   
Principal Investigator: Burt Nabors, MD         
United States, Arizona
Center for Neurosciences Recruiting
Tucson, Arizona, United States, 85718
Contact: Margie Pazzi, RN, MSN    520-320-2147    mpazzi@neurotucson.com   
Contact    520.795.7750      
Principal Investigator: Michael Badruddoja, MD         
United States, California
California Cancer Care Associates Recruiting
Encinitas, California, United States, 92024
Contact: Beth Kimball, RN OCN    760-452-3909    bkimball@ccare.com   
Principal Investigator: Edward McClay, MD         
John Wayne Cancer Institute @ Providence St Johns Health Center Recruiting
Santa Monica, California, United States, 90404
Contact: Anand Moses    310-582-7097    mosesa@jwci.org   
Principal Investigator: Garni Barkhoudarian, MD         
United States, Connecticut
Associated Neurologists of Southern CT, PC Recruiting
Fairfield, Connecticut, United States, 06824
Contact: Tori Pascoe, CRC    203-333-1151 ext 4    tpascoe@anscneuro.com   
Principal Investigator: Nicholas Blondin, MD         
United States, District of Columbia
George Washington University Not yet recruiting
Washington, District of Columbia, United States, 20037
Contact: Lindsey Covington         
Principal Investigator: Jonathan Sherman         
United States, Florida
Boca Raton Regional Hospital Recruiting
Boca Raton, Florida, United States, 33486
Contact: Pilar Zuniga, MD    561-955-4800    pzuniga@brrh.com   
Principal Investigator: Sajeel Chowdhary, MD         
United States, Kansas
University of Kansas Medical Center (KUMC) Not yet recruiting
Kansas City, Kansas, United States, 66205
Contact: Sasha Moores    913-588-5520    smoores@kumc.edu   
Principal Investigator: Michael Salacz, MD         
United States, Texas
Cancer Care Collaborative Recruiting
Austin, Texas, United States, 78705
Contact: Heidi Herndon, RN    512-324-7000 ext 77713    hherndon@ascension.org   
Principal Investigator: Brian D Vaillant, MD         
Baylor Scott and White Health Recruiting
Temple, Texas, United States, 98101
Contact: Dedra Preece    254-724-5939    dedra.preece@bswhealth.org   
Contact: Gates Anderson    254.724.5889    Gates.Anderson@bswhealth.org   
Principal Investigator: Ekokobe Fonkem, DO         
Sponsors and Collaborators
Nativis, Inc.
Investigators
Study Chair: Donna Morgan Murray, PhD Nativis, Inc.
More Information
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Responsible Party: Nativis, Inc.
ClinicalTrials.gov Identifier: NCT03276286     History of Changes
Other Study ID Numbers: NAT109
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

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