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

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02296580
• Other study ID #: NAT-101
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: September 30, 2021

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 with first or second recurrence of GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to 32 subjects with Voyager plus lomustine with or without bevacizumab. Safety and clinical utility will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject has histologically confirmed diagnosis of GBM.
• Subject has failed or intolerant to radiotherapy.
• Subjects has failed or intolerant to temozolomide therapy.
• Subject has progressive disease with at least one measureable lesion on MRI.
• Subject is at least 18 years of age.
• Subject has a KPS = 60.
• Subject has adequate organ and marrow function.

Exclusion Criteria:

• Subject has received bevacizumab (Avastin).
• Subjecting has any condition, including compromised pulmonary function, that would preclude the use of lomustine.
• Subject is currently being treated with other investigational agents.
• Subject has received other investigational therapy within the last 28 days.
• Subject has received surgery within the last four weeks.
• Subject is within 12 weeks of completion of radiation.
• Subject has an active implantable or other electromagnetic device.
• Subject has a metal implant, including a programmable shunt, 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 course of the study.

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Device:
• Nativis Voyager RFE Therapy
Nativis Voyager Radiofrequency Energy Therapy

Locations

Country	Name	City	State
Australia	St Vincent's Hospital Melbourne	Melbourne
United States	Cancer Care Collaborative	Austin	Texas
United States	University of Alabama at Birmingham (UAB)	Birmingham	Alabama
United States	Boca Raton Regional Hospital	Boca Raton	Florida
United States	cCARE - California Cancer Associates for Research & Excellence	Encinitas	California
United States	Associated Neurologists of Southern CT, P.C.	Fairfield	Connecticut
United States	University of Kansas Medical Center (KUMC)	Kansas City	Kansas
United States	Providence Brain & Spine Institute	Portland	Oregon
United States	John Wayne Cancer Institute @ Providecne St. Johns Health Center	Santa Monica	California
United States	Swedish Medical Center	Seattle	Washington
United States	Virginia Mason Hospital & Medical Center	Seattle	Washington
United States	Baylor Scott & White Health	Temple	Texas
United States	Center for Neurosciences	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Nativis, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of any adverse events associated with the investigational therapy.	Safety Assessment as assessed by adverse events	Through one month following investigational treatment
Secondary	Clinical Utility: PFS	Progression Free Survival as assessed by RANO	Six months
Secondary	Clinical Utility: OS	Overall Survival	18 months