Nativis Voyager for Newly Diagnosed GBM

NCT03276286 | Completed FDA Device

• 1 other identifier: NAT109
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 7

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.

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• Treatment-related Adverse Events (Safety)

  Safety as measured by number of investigational treatment-related adverse events as assessed by CTCAE v4.0.

  Through study completion, average of 1 year

Secondary Outcomes (2)

• Clinical Utility PFS

  6 months

• Clinical Utility OS

  Through patient completion, expected average 8 months

Study Arms (1)

Nativis Voyager

EXPERIMENTAL

Nativis Voyager combined with SOC Radiotherapy and temozolomide

Device: Nativis Voyager

Interventions

Nativis Voyager DEVICE

Nativis Voyager treatment combined with standard of care radiotherapy and temozolomide

Nativis Voyager

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• There is pathological evidence of GBM using World Health Organization (WHO) classification.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nativis, Inc.: lead

Study Sites (7)

Center for Neurosciences

Tucson, Arizona, 85718, United States

Location

California Cancer Care Associates

Encinitas, California, 92024, United States

Location

John Wayne Cancer Institute @ Providence St Johns Health Center

Santa Monica, California, 90404, United States

Location

Associated Neurologists of Southern CT, PC

Fairfield, Connecticut, 06824, United States

Location

Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States

Location

Cancer Care Collaborative

Austin, Texas, 78705, United States

Location

Baylor Scott and White Health

Temple, Texas, 98101, United States

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Donna Morgan Murray, PhD

  Nativis, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Nativis Voyager combined with standard radiotherapy and temozolomide

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 8, 2017
• Study Start: November 10, 2017
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)