NCT02296580

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

7.7 years

First QC Date

November 18, 2014

Last Update Submit

January 31, 2023

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

  • Number of any adverse events associated with the investigational therapy.

    Safety Assessment as assessed by adverse events

    Through one month following investigational treatment

Secondary Outcomes (2)

  • Clinical Utility: PFS

    Six months

  • Clinical Utility: OS

    18 months

Study Arms (1)

Nativis Voyager RFE Therapy

EXPERIMENTAL

Subjects will be treated with Nativis Voyager therapy until tumor progression.

Device: Nativis Voyager RFE Therapy

Interventions

Nativis Voyager RFE TherapyDEVICE

Nativis Voyager Radiofrequency Energy Therapy

Nativis Voyager RFE Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.
  • Subject is at least 18 years of age.
  • Subject has a KPS ≥ 60.
  • Subject has adequate organ and marrow function.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35233, United States

Location

Center for Neurosciences

Tucson, Arizona, 85718, United States

Location

cCARE - California Cancer Associates for Research & Excellence

Encinitas, California, 92024, United States

Location

John Wayne Cancer Institute @ Providecne St. Johns Health Center

Santa Monica, California, 90404, United States

Location

Associated Neurologists of Southern CT, P.C.

Fairfield, Connecticut, 06824, United States

Location

Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States

Location

University of Kansas Medical Center (KUMC)

Kansas City, Kansas, 66205, United States

Location

Providence Brain & Spine Institute

Portland, Oregon, 97225, United States

Location

Cancer Care Collaborative

Austin, Texas, 78705, United States

Location

Baylor Scott & White Health

Temple, Texas, 76508, United States

Location

Virginia Mason Hospital & Medical Center

Seattle, Washington, 98101, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

St Vincent's Hospital Melbourne

Melbourne, Australia

Location

Related Publications (1)

  • Barkhoudarian G, Badruddoja M, Blondin N, Chowdhary S, Cobbs C, Duic JP, Flores JP, Fonkem E, McClay E, Nabors LB, Salacz M, Taylor L, Vaillant B, Gill J, Kesari S. An expanded safety/feasibility study of the EMulate Therapeutics Voyager System in patients with recurrent glioblastoma. CNS Oncol. 2023 Sep 1;12(3):CNS102. doi: 10.2217/cns-2022-0016. Epub 2023 Jul 18.

    PMID: 37462385DERIVED

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, 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

November 18, 2014

First Posted

November 20, 2014

Study Start

February 1, 2014

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

February 2, 2023

Record last verified: 2023-01

Locations

US(12)AU(1)