Nativis Voyager for Newly Diagnosed GBM (NAT109)

• ClinicalTrials.gov Identifier: NCT03276286
• Recruitment Status: Active, not recruiting
• First Posted: September 8, 2017
• Last Update Posted: August 20, 2019
• Sponsor: Nativis, Inc.
• Information provided by (Responsible Party): Nativis, Inc.

Study Description

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 37 participants
• Allocation: N/A
• 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: January 31, 2020
• Estimated Study Completion Date: January 31, 2020

Arms and Interventions

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

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

• 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

Locations

United States, Arizona

Center for Neurosciences

Tucson, Arizona, United States, 85718

United States, California

California Cancer Care Associates

Encinitas, California, United States, 92024

John Wayne Cancer Institute @ Providence St Johns Health Center

Santa Monica, California, United States, 90404

United States, Connecticut

Associated Neurologists of Southern CT, PC

Fairfield, Connecticut, United States, 06824

United States, Florida

Boca Raton Regional Hospital

Boca Raton, Florida, United States, 33486

United States, Texas

Cancer Care Collaborative

Austin, Texas, United States, 78705

Baylor Scott and White Health

Temple, Texas, United States, 98101

Sponsors and Collaborators

Nativis, Inc.

Investigators

• Study Chair: Donna Morgan Murray, PhD; Nativis, Inc.

More Information

• Responsible Party: Nativis, Inc.
• ClinicalTrials.gov Identifier: NCT03276286
• Other Study ID Numbers: NAT109
• First Posted: September 8, 2017
• Last Update Posted: August 20, 2019
• Last Verified: August 2019

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
• 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