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Nativis Voyager for Newly Diagnosed GBM (NAT109)

This study is currently recruiting participants.
Verified November 2017 by Nativis, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03276286
First Posted: September 8, 2017
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Nativis, Inc.
  Purpose
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 11 subjects and will be combined with standard of care radiotherapy and temozolomide.

Condition Intervention
Glioblastoma Multiforme Device: Nativis Voyager

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Nativis, Inc.:

Primary Outcome Measures:
  • 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:
  • Clinical Utility PFS [ Time Frame: 6 months ]
    Progression Free Survival

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


Estimated Enrollment: 10
Actual Study Start Date: November 10, 2017
Estimated Study Completion Date: March 31, 2019
Estimated Primary Completion Date: March 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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, Arizona
Center for Neurosciences Recruiting
Tucson, Arizona, United States, 85718
Contact: Margie Pazzi, RN, MSN       mpazzi@neurotucson.com   
Principal Investigator: Michael Badruddoja, MD         
United States, California
John Wayne Cancer Institute 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, P.C. Recruiting
Fairfield, Connecticut, United States, 06824
Contact: Tori Pascoe, CRC    203-333-1151 ext 5    tpascoe@anscneuro.com   
Principal Investigator: Nicholas Blondin, MD         
United States, Texas
Baylor Scott and White Health Not yet recruiting
Temple, Texas, United States, 98101
Contact: Dedra Preece    254-724-5939    dedra.preece@bswhealth.org   
Principal Investigator: Ekokobe Fonkem, DO         
Sponsors and Collaborators
Nativis, Inc.
  More Information

Responsible Party: Nativis, Inc.
ClinicalTrials.gov Identifier: NCT03276286     History of Changes
Other Study ID Numbers: NAT109
First Submitted: September 5, 2017
First Posted: September 8, 2017
Last Update Posted: November 14, 2017
Last Verified: November 2017
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