Nativis Voyager for Newly Diagnosed GBM

Glioblastoma Multiforme Clinical Trial

— NAT109  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03276286
• Other study ID #: NAT109
• Status: Completed
• Phase: N/A
• Start date: November 10, 2017
• Est. completion date: May 31, 2022

Study information

• Verified date: January 2023
• Source: Nativis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Device:
• Nativis Voyager
Nativis Voyager treatment combined with standard of care radiotherapy and temozolomide

Locations

Country	Name	City	State
United States	Cancer Care Collaborative	Austin	Texas
United States	Boca Raton Regional Hospital	Boca Raton	Florida
United States	California Cancer Care Associates	Encinitas	California
United States	Associated Neurologists of Southern CT, PC	Fairfield	Connecticut
United States	John Wayne Cancer Institute @ Providence St Johns Health Center	Santa Monica	California
United States	Baylor Scott and White Health	Temple	Texas
United States	Center for Neurosciences	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Nativis, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical Utility PFS	Progression Free Survival	6 months
Secondary	Clinical Utility OS	Overall Survival	Through patient completion, expected average 8 months