NAT109: Nativis Voyager for Newly Diagnosed GBM

Sponsor

Nativis, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03276286

Collaborator

(none)

Enrollment

Locations

Arm

26.7

Anticipated Duration (Months)

5.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Nativis Voyager combined with standard radiotherapy and temozolomideNativis 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 :

Nov 10, 2017

Anticipated Primary Completion Date :

Jan 31, 2020

Anticipated Study Completion Date :

Jan 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

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

Treatment-related Adverse Events (Safety) [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 [6 months]
Progression Free Survival
Clinical Utility OS [Through patient completion, expected average 8 months]
Overall Survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	Center for Neurosciences	Tucson	Arizona	United States	85718
2	California Cancer Care Associates	Encinitas	California	United States	92024
3	John Wayne Cancer Institute @ Providence St Johns Health Center	Santa Monica	California	United States	90404
4	Associated Neurologists of Southern CT, PC	Fairfield	Connecticut	United States	06824
5	Boca Raton Regional Hospital	Boca Raton	Florida	United States	33486
6	Cancer Care Collaborative	Austin	Texas	United States	78705
7	Baylor Scott and White Health	Temple	Texas	United States	98101

Sponsors and Collaborators

Nativis, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nativis, Inc.

ClinicalTrials.gov Identifier:

NCT03276286

Other Study ID Numbers:

NAT109

First Posted:

Sep 8, 2017

Last Update Posted:

Aug 20, 2019

Last Verified:

Aug 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Glioblastoma

Study Results

No Results Posted as of Aug 20, 2019