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

NCT02507102 | Completed

• 1 other identifier: NAT-105
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This feasibility study will assess the effects of the Nativis Voyager therapy in patients with recurrent GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to eleven subjects over six months. Safety and clinical utility will be evaluated.

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (2)

• Incidence and evaluation of any serious adverse events associated with the Nativis Voyager System

  6 months

• Tumor Response

  Tumor imaging response (RANO) at two months of therapy.

  2 months

Secondary Outcomes (2)

• Overall survival at six months compared with historical response

  6 months

• Progression free survival

  6 months

Study Arms (1)

Investigational Voyager Therapy

EXPERIMENTAL

Investigational treatment with Voyager Therapy

Device: Voyager

Interventions

Voyager DEVICE

Non-invasive RFE therapy

Investigational Voyager Therapy

Eligibility Criteria

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

You may qualify if:

• 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 or CT.
• Subject is at least 18 years of age.
• Subject has a KPS ≥ 60.
• Subject has adequate organ and marrow function.
• Subject has provided signed informed consent.

You may not qualify if:

• Subject has life expectancy less than eight weeks
• Subject has received other investigational therapy within the last 28 days.
• Subject has received surgery within the last two weeks or not fully from prior surgery.
• Subject has a clinically significant electrolyte abnormality.
• Subject has an active implantable (e.g., neurostimulator, pacemaker) or other electromagnetic device.
• 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 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 (1)

St. Vincent's Hospital Melbourne

Melbourne, Victoria, 3065, Australia

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 DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: July 23, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: March 26, 2018
• Last Updated: March 30, 2018

Record last verified: 2018-03

Locations

AU (1)