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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02296580
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Nativis, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Donna Morgan Murray, PhD
Principal Investigator Affiliation Nativis, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Completed
Countries Australia, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma Multiforme
Arms & Interventions

Arms

Experimental: Nativis Voyager RFE Therapy

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

Interventions

Device: - Nativis Voyager RFE Therapy

Nativis Voyager Radiofrequency Energy Therapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

Status

Address

University of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35233

Center for Neurosciences, Tucson, Arizona

Status

Address

Center for Neurosciences

Tucson, Arizona, 85718

Encinitas, California

Status

Address

cCARE - California Cancer Associates for Research & Excellence

Encinitas, California, 92024

Santa Monica, California

Status

Address

John Wayne Cancer Institute @ Providecne St. Johns Health Center

Santa Monica, California, 90404

Fairfield, Connecticut

Status

Address

Associated Neurologists of Southern CT, P.C.

Fairfield, Connecticut, 06824

Boca Raton Regional Hospital, Boca Raton, Florida

Status

Address

Boca Raton Regional Hospital

Boca Raton, Florida, 33486

Kansas City, Kansas

Status

Address

University of Kansas Medical Center (KUMC)

Kansas City, Kansas, 66205

Providence Brain & Spine Institute, Portland, Oregon

Status

Address

Providence Brain & Spine Institute

Portland, Oregon, 97225

Cancer Care Collaborative, Austin, Texas

Status

Address

Cancer Care Collaborative

Austin, Texas, 78705

Baylor Scott & White Health, Temple, Texas

Status

Address

Baylor Scott & White Health

Temple, Texas, 76508

Virginia Mason Hospital & Medical Center, Seattle, Washington

Status

Address

Virginia Mason Hospital & Medical Center

Seattle, Washington, 98101

Swedish Medical Center, Seattle, Washington

Status

Address

Swedish Medical Center

Seattle, Washington, 98122

International Sites

St Vincent's Hospital Melbourne, Melbourne, Australia

Status

Address

St Vincent's Hospital Melbourne

Melbourne, ,

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